I'm John Sperzel, Chairman and CEO at T2 Biosystems. Welcome to our 2022 Analyst and Investor Day. I'll start with our safe harbor statement, which can be found in the investor relations section of the company's website, and remind you that our presentation may contain forward-looking statements and that actual results may differ from these statements. Today's agenda includes a company overview, which will be led by me. A panel discussion led by our Chief Medical Officer, Dr. Aparna Ahuja. Our commercial strategy led by our Chief Commercial Officer, Brett Giffin. Product pipeline led by our Senior Vice President of Science Research a nd Development, Roger Smith. Financial summary led by our Chief Financial Officer, John Sprague, and a Q&A session with the management team. Let's start with a company overview.
Our mission is to fundamentally change the way medicine is practiced through transformative culture-independent diagnostics that improve the lives of patients around the world. We have a patented technology platform, novel diagnostic tests focused on sepsis, a multi-billion-dollar market opportunity, established U.S. reimbursement under the DRG payment system, a robust product pipeline funded by up to $69 million from the U.S. government or BARDA, and heavy focus on commercialization targeting the hospital market. Our focus is sepsis, the body's overwhelming and life-threatening response to an infection, which is a global problem with fatal consequences. An estimated 11 million people die with sepsis each year worldwide, more than all cancers combined. Sepsis contributes to one in five deaths globally. In the U.S., sepsis is the number one cause of hospitalization, costing nearly $62 billion annually.
It's the number one cause of death in U.S. hospitals, claiming nearly 270,000 American lives each and every year. Sepsis is the number one cause of 30-day hospital readmissions, requiring nearly 20% of survivors to be re-hospitalized within 30 days. To advance our mission, we've set three corporate priorities for 2022: accelerating our sales, enhancing our operations, and advancing our pipeline. I will now turn the presentation over to Dr. Ahuja to lead the panel discussion on culture-independent diagnostics.
Good afternoon to all participating and attending the session today. I'm excited to chair the panel discussion on sepsis and clinical value of T2 Biosystems sepsis panels. Joining us today as key panelists are Dr. Thomas Walsh, the Founding Director, Center for Innovative Therapeutics and Diagnostics, Investigator of Emerging Infectious Diseases of the Save Our Sick Kids Foundation, and Adjunct Professor of Medicine, Microbiology, and Immunology, University of Maryland School of Medicine. Thanks, Dr. Walsh, for joining. We have Dr. James Snyder, Professor of Pathology and Laboratory Medicine, Director of Microbiology and Infectious Diseases Molecular Diagnostics at the University of Louisville School of Medicine . Thank you, Dr. Snyder. Sepsis is the body's extreme response to an infection and is a potentially life-threatening medical emergency. Sepsis is a burdensome condition across the world in terms of morbidity, mortality, and healthcare cost.
Sepsis represents $62 billion in U.S. healthcare cost, claims more lives each year than three leading causes of cancer deaths combined. The CDC data states that each year, 1.7 million adults in U.S. develop sepsis. 270,000 Americans die as a result of sepsis. One in three patients who die in hospital have sepsis. Another concerning fact is that the hospitalized COVID-19 patient, as compared to hospitalized influenza patients, faces a 22% higher risk of developing sepsis and is 113% more likely to experience septic shock. Antimicrobial resistance is also on the rise globally and is one of the biggest public health challenges of our time. The CDC reports that each year in the U.S., more than 2.8 million people get an antibiotic-resistant infection and more than 35,000 die.
Antimicrobial-resistant infections are estimated to cause 1.27 million deaths annually worldwide. If no action is taken, the death toll because of AMR could rise to as many as 10 million deaths annually by 2050 and cause a 3.8% reduction in annual gross domestic product. Also, extended time from presentation to appropriate therapy continues to be a major contributor to poor patient outcomes and proliferation of antimicrobial resistance. The current standard to detect sepsis-causing pathogens, blood culture, is a race against time, thus the reliance on empiric probability-based protocols which are optimal only in 30%-60% of cases. The time to positivity of a blood culture varies and on an average takes two to three days, which can delay time-sensitive, life-saving targeted treatment.
Other limitations of blood culture are that the positivity rates are low, contamination rates are high, administering antibiotics prior to culture and improper or inadequate specimen collection can alter results. Survival decreases by 7.6% during septic shock for every hour delay in time to appropriate therapy. Also, prolonged use of broad-spectrum antimicrobials is a key risk factor associated with development and spread of antimicrobial resistant organisms. On the left of the slide is the time of sample collection, and it takes about one to five days to get a positive blood culture. The culture-based rapid diagnostic test, which you can see on the right side of the slide, can provide species identification rapidly in one to three hours, however, only after a positive blood culture. They cannot be leveraged until culture becomes positive and cannot be utilized in cases of culture negative sepsis.
Culture negative sepsis is a common clinical concern where the patient appears septic with a lack of pathogen growth on culture. Non-culture-based test, T2 panels provide sepsis, species, and resistance gene identification directly from whole blood within three to five hours, are not reliant on culture positivity or influenced by antibiotic intake prior to the test. On this slide, you will see the various products that T2 Biosystems has. The FDA-cleared T2Dx Instrument on the left is a fully automated walkaway clinical multiplex benchtop. Seven individual random access drawers, which can be loaded at any time, so no batching is required. Its user-friendly touch screen display provides step-by-step guidance to the operator to load a sample. I t's a proprietary methodology which enables inhibition-free DNA amplification in complex clinical matrices. There's no background interference from either human DNA or antibiotics, et cetera.
Simplifies process and eliminates extraction and purification of targets. The technology enables measurement direct from patient sample, thus higher sensitivity with the limit of detection as low as 1 CFU/mL and sensitivity as high as more than 98%. Both T2Candida Panel and T2Bacteria Panel are FDA-cleared and CE marked. Candida is the fourth most common isolate in U.S. and seventh most common in Europe for fungal bloodstream infections. The T2Candida Panel identifies the five fungal pathogens that lead to more than 90% of invasive candidiasis. The T2Bacteria Panel is designed for the detection of most of the ESKAPE pathogens and E. coli, which are a group of infectious bacteria that have garnered particular attention for their ability to escape or evade common therapies through antimicrobial resistance.
ESKAPE pathogens are resistant against common empirical therapies and are responsible for majority of nosocomial infections. These pathogens remain a major healthcare burden and are associated with highest risk of mortality and increased healthcare cost. A recent study found that ESKAPE pathogens when compared to non-ESKAPE pathogens were associated with 3.3 days increase in length of stay, a $5,500 increase in cost of care, and 2.1% absolute increase in mortality. Coming to the T2Resistance Panel, which has a sensitivity and specificity of more than 99%, detects 13 molecular markers of antibiotic resistance for both gram-positive and gram-negative organisms. This panel is CE marked and is available in the U.S. as research use only product. It is not yet FDA cleared and the clinical trial for its FDA submission is currently ongoing. The T2SARS-CoV-2 Panel is a swab test.
It's available in the U.S. under EUA with an NPA of 100% and PPA of 95%. It detects all variants so far of COVID-19 virus, including Omicron. There is growing real-world evidence demonstrating positive impact of T2Candida and T2Bacteria on patient care and antimicrobial stewardship. Across hospitals, we note reduction in ICU and hospital length of stay, faster initiation of targeted therapy, as well as discontinuation of antimicrobials and hospital savings. To mention one of such articles, in May 2021, meta-analysis of 14 controlled studies was published in a peer-reviewed journal, which highlights the benefits of T2 panel as compared to blood culture. Results were as follows.
T2 showed faster time to detection and species identification as compared to blood culture by three days, faster time to targeted antimicrobial therapy for patients testing positive on T2 by 42 hours, almost two days, and faster time to de-escalation from empirical therapy for patients testing negative on T2 by seven hours. Shorter length of ICU stay and hospital stay by five days was seen on patients tested by T2. Now I'd like to open up the discussions and invite the key panelists for answering the questions. I would like to pose the first question to Dr. Thomas Walsh. Dr. Walsh, what is sepsis and why is time of critical importance in sepsis management?
Well, Aparna, I think, as we try to understand the importance of diagnosing sepsis, it's critical to understand what is sepsis and how the relentless process further injures host tissue. We can define sepsis as the immune system's response to severe infections, including those caused by bacterial, fungal, or viral pathogens in response to what we call pathogen-associated molecular patterns, PAMPs, that lead to tissue injury, organ failure, and death. This tissue injury is also inflicted by the microbial pathogens directly through a wide variety of virulence factors. Both organism-mediated injury and host inflammatory damage are contributing in real time to the release of a host of molecules known as danger-associated molecular patterns, DAMPs, which circulate in a negative feedback loop to paralyze host response to microbial pathogens.
The pathophysiology of sepsis impacts in a multi-system way, directly affecting lungs, kidney, the coagulation system, central nervous system, cardiovascular system. All of this is ensuing in part from release of lipopolysaccharides from gram-negative pathogens, of peptidoglycan from gram-positive pathogens interacting with toll-like receptors, triggering the re-release of NF-κB, further going into the nucleus and then resulting in transcriptional upregulation and release of IL-1β, TNF-α, IL-10. These are potent pro-inflammatory and immunomodulatory molecules that then further propagate prostaglandins, protease, leukotrienes, and oxidative metabolites from phagocytic cells.
All of this is ensuing then with the damage to lungs, where we see ARDS, with the damage to kidneys, where we see renal failure, with the damage to the heart, where we see diminished cardiac output, to the coagulation system, where we see a hypercoagulable state in DIC, and then to the central nervous system with impaired cerebral blood flow. All of this is ensuing literally over hours. As we speak about sepsis, it is paramount therefore to be able to rapidly diagnose it, diagnose the cause, and initiate a timely therapy in order to prevent the relentless tissue injury, organ failure, and death from multi-system dysfunction.
Thank you. Thank you, Dr. Walsh. Very informative. Dr. Snyder, I would like to understand from your perspective, what are the limitations of current culture-based diagnostics, and what is the current standard for testing of bloodstream infections?
Thank you, Aparna. I appreciate it. Blood cultures are regarded as the reference or gold standard for diagnosing bloodstream infections, just like cultures of urine, respiratory, and other sites that we culture for determining the etiological agent. Blood cultures currently represent the main method for determining the etiology or the causative organism of a bloodstream infection because they are highly sensitive. The sensitivity, I should emphasize, is dependent to a great extent on the volume of blood that is collected, which currently 20 mL is considered the optimal volume for one blood culture. That translates into multiple blood cultures being collected in patients suspected of sepsis and/or bacteremia. Before antibiotics are administered, we always try to get our blood cultures collected before antibiotics are administered. That's not always the case, but ideally, we want two to four blood cultures.
Two to four blood cultures would represent 40 mL-80 mL of blood necessary to detect 80%-96% of bacteremia or fungemia. Blood volume drives sensitivity of the gold standard that we refer to as the blood culture. There are some drawbacks of a blood culture, what we call a longer turnaround time or duration of time required for the detection of the organism, which is dependent upon growth of the organisms. In general, anywhere from 24 hours to five days to recover an organism in a blood culture, 'cause once again, the blood culture is a growth-dependent technology. We need viable organisms. Any delay or even failure to detect microorganisms in the bloodstream infections when the patient has previously received antibiotics can be another problem.
We have to understand the impact that prior administration of antibiotics will have on the viability of the organisms, and et cetera. On the other hand, the T2 system is culture independent. It addresses, if you will, the direct specimen. Being culture independent, we can directly detect the current organisms that you saw previously on the screen, the five bacteria and the five fungal isolates. But we also remember that this technology is not, and I emphasize, is not intended to replace the standard blood culture. Be advised, the T2 technology currently is the only technology of its kind, and there is no other technology like it, from the perspective that within three to five hours in a 4 mL blood specimen, we can detect these respective organisms that were summarized in the previous slides.
There are occasions when there will be other agents that are not in the T2 database. We have both the 4- mL blood specimen along with the accompanying blood culture. Very important that when the T2 sample's collected, that a blood culture accompany it. Thank you.
Thank you, Doctor Snyder. I would like to continue this discussion since you mentioned it, the advantage and limitations of the current standard and T2 panels. What attracted you to pursue adoption of T2 panels at your facility? To add to that question, I would say could you also highlight the process followed for the implementation of T2Bacteria Panel and T2Candida Panel in the routine clinical usage in your facility? Doctor Snyder.
Several years ago, defined as five to eight years ago, we made the decision that we are in the era of rapid diagnostics. The technologies are there to assist in obtaining diagnostic information in relatively short period of time. Our laboratory is driven by that philosophy of rapid diagnostics. That drives our current planning as well. Realizing that the longer turnaround time may and often results in delays of administering appropriate and pathogen-directed antimicrobial therapy, we realize that there's additional consequences associated with that, such as increased length of stay, higher complication rates, and ultimately increased healthcare costs. As a result of that, highlighting the process that we followed to implement this technology, approximately five years ago, sepsis became a very important and focused situation or problem in our system.
I thought at this time that the T2 would be an ideal technology to evaluate and play potentially a key role in supporting the sepsis protocol that is in our institution, beginning with the emergency room. Not only the sepsis protocol, but also antimicrobial stewardship. Antimicrobial stewardship is another key program that all of us are expected to follow per the CMS and the federal government in general. Antimicrobial stewardship. Once again, we get the answer sooner. We start antibiotics, the appropriate, and I emphasize appropriate antibiotics, sometimes referred to as targeted therapy, much sooner. Now, at that particular time that we began to investigate the T2, the T2Candida Panel was the only test panel that was available at the time. We evaluated it, and shortly thereafter, the T2Bacteria Panel became available, actually about 2.5 years later.
We decided to conduct an evaluation along with our team, and this is another factor that is very, very important in acquiring and applying such technology. That team consisted of our pharmacy colleagues, infectious disease colleagues, and selected clinicians from some of the specialty services, namely oncology, bone marrow, organ transplants, and of course, our emergency room. We conducted the evaluation, and we also know that fungemia is a big problem in our oncology and our transplant patients, especially bone marrow. The evaluation overall was successful, and shortly thereafter, we had an opportunity to evaluate the bacterial panel. As a result of that evaluation was as well accepted. Keep in mind, we were also looking at the potential impact on patient outcome and the use of antibiotics. It's just not an analytical evaluation.
We carried it over to impact on patients. The data for both the fungal and the bacterial panels were very good, as I indicated. We requested that the instrument be acquired. Both pharmacy and infectious diseases were very supportive. After many months of negotiation with the administration, the director of the cancer center, who was totally in support of its use in the bone marrow center, as well as the individual that directed the solid organ transplant program, they really wanted this test. They wrote a letter to the hospital administration endorsing our request and offering a tremendous amount of support. Shortly thereafter, shortly being within a month, the system was acquired, and we have been live for nearly two years. It's been, without a doubt, a team effort to accomplish this.
At this point in time, it's been very successful and continues to be.
Thank you, Dr. Snyder. Just to add, because you mentioned a lot about the team effort along with all the great points that you highlighted. During your implementation process, were there any requirements that you needed any support from T2? Was the T2 Biosystems team able to provide you support as needed at any time?
The support from T2 has been simply outstanding. Initially when we went live, their representatives came in and trained our phlebotomists on the collection of the T2 sample. They trained the nursing staff and yes, they even trained some of the physicians in their respective units. Now, not to go into great detail, but we offer this assay to selected services, namely the emergency room, the intensive care units, oncology, and of course the transplant units, bone marrow and solid organs, respectively. Infectious Diseases is a major player on the team, and they are allowed to order the test as well. Anyone outside of those services have to get an ID consult in order for that test to be ordered. We are also a 24/7 service where we have a dedicated microbiology staff around the clock 24/7.
As I indicated earlier, instruments of this type or technology are designed to run 24/7. We were fortunate, as I said, to convince the administration, not just because of the T2, but because of our other rapid diagnostic technologies, to support our efforts in creating a dedicated 24/7 technical staff. Now, I must admit that during COVID-19 it was quite challenging. With COVID-19 being such a problem in our high volume of testing, we never missed a beat because the instrument T2 is located in our molecular lab in proximity to the platforms that we were using to do COVID-19 testing. While COVID-19 testing were being run, the T2 was available for the technologist to program and initiate.
One of the big things about the T2 from the administrative or cost point of view is there's less than five minutes of labor. Labor expenditure, which administrators look at, is minimal. Which we think is a very good benefit of a technology of this type. Also, the technology is very simple. It's fully automated. Minimal training of personnel, but we extended the number of people that were trained so we could facilitate more testing. As I said, there's five minutes or less hands-on time, and the time to result's three to five hours. As I said, the training was also conducted for the nursing staffs in those respective services that I mentioned earlier.
Our goal is to have the phlebotomy team, which, a dedicated phlebotomy team, to collect all the blood samples and try to avoid having the nurses collect them. Right now it's probably 80% phlebotomy drawn, but the remainder 20% are drawn by nurses. From a workflow perspective, the instrument does and has fit into our system extremely well. Even though staffing has been a challenge, we still have been able to maintain our T2 services 24/7. The company has provided not only the training support but technical support when we do encounter what we would call downtime. I have to be very complimentary of their response and their sincerity in responding to our needs.
Sometimes, although it's minimal, we can repair or conduct getting the system back online by phone. Once again, I can emphasize technical support is very important and T2 Biosystems has risen to the challenge. Not much, but when we do need them, they are there, and I can't tell you how much we appreciate that.
Thank you.
As a result of that, they have been very, very good to work with.
Thank you. Thank you, Dr. Snyder. As I understand that the T2 panels and the instrument fits very well into the clinical labs workflow of yours, right?
Not a problem.
Yeah. Also I really like the way you mentioned about the synergy between the ID doctors and the lab experts and the pharmacy. Since we heard your perspective as a lab expert, I'm thinking, Dr. Walsh, you could actually share your experiences as to how what are the benefits of T2Bacteria Panel and T2Candida P anel that you have experienced in your clinical practice. Please describe the way it fits very well into the clinical lab workflow that way. How does it fit into the sepsis management clinical flow? When and how do you use the panels? Dr. Walsh to you.
Thank you. Thank you, Aparna, and thank you, Dr. Snyder. I think it's helpful to take an historical perspective. I have had the privilege of being involved with the original development, conceptual development of T2Candida and guiding with the T2 team the selection of organisms and the anticipated standards, and then with that was also involved in the original concepts, conceptual development, selection of organisms and anticipated performance standards also with T2Bacteria. With T2Bacteria, we were fortunate to participate in the pivotal study, which really defined and is helpful to understand the performance standards.
Basically that study with T2Bacteria demonstrated that if we look at positive blood cultures amongst more than 1,400 blood cultures drawn, 3% were positive in patients with for bacterial infections, and 13% were positive for those T2Bacteria. Strikingly, not only was there a greater degree of detection of organisms that even on further analysis were found largely to be highly accurate and likely more sensitive, but also we were able to see a striking improvement, almost tenfold difference in time to positivity. If you were to look, for example, at the time to positivity, that was approximately four hours for T2Bacteria and approximately 40 hours for conventional blood cultures.
If we were to look at species identification, it was approximately seven hours for T2Bacteria and 70 hours for conventional blood cultures with subsequent phenotypic analysis. In that regard, we're seeing a striking ability and consistent with the need for intervening clinically, therapeutically in septic patients suspected of having sepsis or bloodstream infections to be able to identify, yes, this patient is infected, yes, we know the organism, and we can also target appropriate therapy. We then also focused in on our oncology patients, where Dr. Helfgott and my other colleagues and I enrolled 84 patients with hematological malignancies and stem cell transplant. Within that, similar to what we saw with the overall study in T2Bacteria, we found 14% of blood cultures were positive.
Forgive me, 14% of T2Bacteria Panel were positive, whereas only 5% were positive by blood cultures. Among the eight cases in which we saw T2 positive blood culture negative cases, they were very consistent with what we anticipate in an oncology population. That is, with translocation across the gastrointestinal tract, including E. coli, Enterococcus faecium, and Pseudomonas aeruginosa. Organisms, particularly Enterococcus faecium and Pseudomonas aeruginosa, which if you know they're present, do have a major impact on altering therapy. With Enterococcus faecium, because of the relatively high frequency of vancomycin-resistant organisms, we may initiate daptomycin. For Pseudomonas aeruginosa, if we know that's present in an oncology patient, we may initiate combination therapy, whether it's with a beta-lactam and aminoglycoside or a beta-lactam and a fluoroquinolone. Certainly there is a role potentially for combination therapy.
Very critically, again recapitulating the observations that we made in the larger T2 bacteria study in our T2 bacteria oncology study, we saw significant differences in time to identification. Approximately four hours on the T2Bacteria Panel in comparison to approximately 48 hours for conventional blood cultures for final ID of the organism. For T2Candida, very similar. In the original study authored by Dr. Mylonakis, the T2Candida demonstrated high degree of specificity with a mean time to positivity or negativity within four hours. That is strikingly a major advance in historical comparison to conventional blood cultures, where we typically will have as much as 48 - 72 hours or no positivity in that regard.
The authors in that study, with which I agree, said and ended their paper with stating that, quote, "T2 represents a major breakthrough, shift into a new era of molecular diagnostics." Our own experience replicates this, where in the adult medical intensive care unit over several years we saw that rapid diagnosis was greatly facilitated within hours and allowed the initiation and continuation of antifungal therapy. Whereas often consideration of invasive candidiasis or disseminated candidiasis in a septic patient is not given that high of recognition. With training and in-servicing, we were able to utilize T2Candida in a way that allowed for definitive initiation and with a high degree of specificity, also the ability to discontinue or to adjust therapy if we thought there was resistant organisms such as with a Candida glabrata.
In that regard, we can address the question, how then do the results from T2Bacteria allow us to adjust our clinical workflow? Within a very rapid period of time, literally, on the same shift, one is already then able to say, "We have Pseudomonas." As I mentioned before, starting combination therapy, which would not be routinely done in most septic patients or patients that are febrile and suspected of having bacteremia. The initiation, for example, of vancomycin for MRSA, that may not be part of the overall protocol. Then finally, only if you have Enterococcus faecium since in many hospitals these are positive to be able to narrow for targeting.
Thank you. Thank you, Dr. Walsh. This is very, very helpful. Affairs team members, we are focused on engaging with key opinion leaders like you, creation of the scientific advisory board, and we leverage your understanding and perspectives on our product's clinical utility, preclinical development, and also post-market release. We are focused on clinical education programs, clinical value awareness generation through publication conferences, webinars, and also to mention the investigator-initiated study. Having said that, I am aware, Dr. Walsh, that you have been an investigator also on some clinical research work on T2Resistance Panel. I would really like to understand from you, what do you believe as a clinician and a very accomplished ID doctor, what is the potential for impact on patient care and clinical value of T2Resistance Panel as an investigational tool?
Thank you for that question, Aparna. We can reflect for a moment that while we're able to make an earlier diagnosis, a more rapid diagnosis for specific pathogens, for example, such as Pseudomonas and E. coli, we're not in a position to necessarily identify the resistance patterns. There's still then obviously the need for culture and then subsequently recovery of organism and then either molecular or phenotypic identification of genes encoding resistance, molecules. That takes considerable time. Yet in our investigation of T2Resistance, where I've had the privilege to serve as PI on the pilot study, working with excellent colleagues from the hospital at University of Perugia and the hospital at Evangelismos in Athens, we have been able to identify a...
What we think is a very key role, insofar, for example, as being able to, using T2Resistance, identify common genes. In the case of T2Resistance, there are 24 resistance genes that are able to be identified, commonly of which, KPC, the metallo-beta-lactamase genes, NDM, VIM, IMP, CTX-M, for example, AMP-C, and then for Staph aureus, of course, with mecA. So it does allow us to be able to identify in parallel with the identification of the organism, whether the organism may have also a resistance profile.
As a case in point, for example, if we were able to find the presence of in T2Resistance, the presence of a carbapenemase producer, for example, for KPC, which otherwise we would just be able to find on T2Bacteria, Klebsiella pneumoniae, then having to wait potentially 48-72 hours by phenotypic analysis, the presence of a carbapenemase-producing gene with the detection of KPC. We could then come in with a more appropriate antimicrobial, for example, ceftazidime-avibactam, that would be able to knock out the KPC with more definitive therapy. We obviously routinely would not be initiating ceftazidime-avibactam as empirical therapy for sepsis, but this would allow us literally within hours, potentially, to be able to target these organisms with the potential for life-saving intervention.
If you initiate antimicrobial therapy, for example, in an early basis for Klebsiella, and you might use a third-generation cephalosporin, or piperacillin-tazobactam. It's as if it was KPC, you're hardly treating anything. The ensuing pathophysiology of sepsis that I outlined with the cellular tissue and organ destruction, that's still ongoing. By comparison, if we can identify an early resistance gene, for example, again, a carbapenemase-producing gene, for example, from KPC, then we're able to come in with definitive therapy. This is revolutionary, and revolutionary in the sense that we can recover the genes directly from blood culture. There are many fine instruments and systems that are able to identify the presence of the genes from organisms that are recovered from blood cultures, but that still is limited by culture positivity.
Here, we're able to detect the genes with the advanced T2MR technology, with the extraction and the T2MR system to be able to identify key resistant genes that would have a profound effect in modifying and adjusting antimicrobial therapy in critically ill patients.
Thank you. Thank you, Dr. Walsh. I would like to close the panel discussion now. We really appreciate your insights, Dr. Snyder and Dr. Walsh, on this critically important topic of diagnostics and management of sepsis patients. Thank you. Now I'd like to hand over to Brett Giffin, our Chief Commercial Officer. Thank you.
I'm Brett Giffin, Chief Commercial Officer for T2 Biosystems. Our commercial strategy involves increasing our instrument installed base and expanding sepsis testing on a worldwide basis. Two predominant themes will carry through my presentation, one being expansion, the other being enhancement. In the United States market, we sell direct. We have 90 instruments as part of our installed base. We've dramatically expanded our sales force in the U.S. to 20 territories covering each of the key regions in the U.S. market. That team is managed by two regional sales directors who are deployed East and West and reporting to a vice president of sales. A big key as part of our process with this expansion has been to focus heavily on the qualitative elements of that team. We've worked hard to...
We've actually been recruiting through the end of 2021 and into early 2022, and have brought on people that have a high degree of experience with selling diagnostic products in U.S. hospitals, but also very importantly and key, they have the experience and the wherewithal to be able to call on multiple decision makers, both on the economic as well as clinical decision-making front, truly selling on more of a, on more of an enterprise-wide level. We've greatly enhanced our training program.
We engaged and partnered with a sales excellence firm called Force Management, who has led a very, very in-depth training of our entire sales team, focusing on deal qualifications, on qualifying of champions, and very importantly, a focus on providing a common language for our sales and management team to use as we work through deal placements and work through our sales progressions. Importantly, this program involves weekly follow-ups, and our own live deals are actually incorporated into that. It's not just a training program that's sort of a one time and then we move on. It's reinforced weekly as we go forward. We've seen really, really nice results from this here in the couple of months since we did that.
To accelerate our sales cycle in the U.S., we have also employed and are very aggressively employing instrument placement programs to primarily short cycle the time it takes for a capital purchase deploy. Obviously, our instruments, you know, in the past have been more capital oriented. By these placement programs, we're able to greatly reduce that time. Essentially, it's a contractual arrangement with the hospital having the ability to buy our and having requirements to buy a certain number of tests at an elevated price. As the COVID-19 pandemic, obviously, transitioned everything in the market, we were a beneficiary of that from an instrument placement perspective.
We were able to place a number of instruments in hospitals that T2 probably would not have had access to in that short time cycle. What that's provided us is an increased installed base of instruments to work from, which we're now aggressively focusing on those originally COVID-19 driven instruments to be converted to sepsis testing. Additionally of note, we've had great success in our recent deals that we've closed in the U.S. with hospitals where we've been able, even though COVID-19 may have been an interest as part of their process to bring us in, but we've been able to secure agreements around transitioning to sepsis testing even right up front in the implementation process. In the international market, unlike the U.S., we sell through distribution partners.
We have an installed base of 55 instruments in the international markets. Much like the U.S., we've also expanded this team. We have a team of three international business managers, one that's focused on the European market, another that's focused in the Middle East region, and then a third most recent that we added beginning of the year that's focused on Asia-Pacific and Latin America. Importantly, this team of international business managers all come with years of experience and great market acuity with the markets that they manage, but also in addition, distributor relationships and the ability to have managed in this type of a setting, you know, with multiple markets. Keeping with the theme of expansion, clearly, we're very aggressively expanding our reach in the international markets.
We've over the last several months added several markets in Asia-Pacific and in Europe, and we have very aggressive plans for further additions in Asia-Pacific as well as in Latin America. Importantly to note, our current base of countries, we operate in 24 countries actively and have another 15 that are part of our targeting efforts for later this year and beyond. Just like in the U.S., we've actually taken and adopted the investment that we made in the Force Management program with the sales training.
We've actually incorporated that into a distribution training model that we're now rolling that out and launching that with our distribution partners in Europe, and we intend to in the other regions, to further enhance their ability to sell our products and also importantly, to be able to drive forecast accuracy. We have a field-based service and support team that is regionally deployed in the U.S. as well as internationally to support all of these commercial efforts. In addition, the sales team and the commercial organizations works very closely in collaboration with our medical affairs team to increase sepsis test utilization at an account level and also to drive overall clinical value awareness. We have a rapidly growing awareness of T2 in the marketplace in a number of areas. T2 has been featured in several independent clinical studies.
In addition, we've had great success with a number of different governmental agencies. Obviously, you know, being granted breakthrough device designation for our T2Resistance Panel with FDA, with CMS, our T2Bacteria being the very first diagnostic product that gained incremental reimbursement through CMS's new NTAP program. With BARDA, we've clearly had a great success of being awarded a significant contract with milestone base for product development funding. Of particular note, and what helps to really accelerate our sales efforts in the U.S. market is our contract with the Vizient organization, which provides access to more than 50% of the nation's acute care hospitals.
Importantly, with this contract, this allows us to actually shorten our sales cycle by the fact that when we get to the end of a deal process with a hospital, we don't have to take a lengthy amount of time negotiating terms and conditions. We already have that contract umbrella through Vizient. So very much an enabler of our efforts in that regard. All of everything that I've discussed before, all of our expansions and training and programs that we're running, although are the foundation for all of that is our ability to successfully implement at a hospital level. We've designed our organization and resourced and built ourselves to be able to execute along that line across the sales, medical affairs, and service organizations.
Clearly, a sales organization driving clinical and economic value proposition on the front end, clear through the process of the medical affairs team working closely with departmental level and the clinical departments on, you know, patient selection criteria on through our service team implementation, and ultimately to drive to routine testing and full integration into an account. All of these efforts on the front end, together with everything we're doing from an expansion perspective, as I mentioned, we've invested heavily in advancing and enhancing our team, as well as being able to integrate all of these efforts across the organization from a commercial perspective, really does give us a great opportunity for outstanding results here in 2022 and clearly sets the table for us, beyond 2022 in the years following.
I'll now be followed by Roger Smith, who will discuss our product pipeline.
I'm Roger Smith, Senior Vice President of Science Research and Development at T2 Biosystems. T2 Biosystems has a number of existing products in our pipeline. This table provides an overview of our progress on the development of these products. The T2Resistance Panel is currently CE marked and available for sale in Europe. In Q4 of 2021, we initiated a clinical trial, which is ongoing to collect additional data for this product for an FDA submission. The T2Biothreat Panel has completed development and has also started a clinical trial in Q4 of last year. The comprehensive panel for the detection of bloodstream infections and antimicrobial resistance has completed feasibility, and development is ongoing for this product. The next generation instrument, which will be used to run the comprehensive panel, is also in development.
The T2Candida Panel is currently in early development and is available for sale as a research use only product. Finally, the T2Lyme Panel has completed feasibility and is in early development. I would like to take the opportunity now to share a little bit more about some of our pipeline products. The T2Resistance Panel, as I indicated, is currently available in Europe. This panel is a direct from blood molecular diagnostic that detects 13 resistance genes from both gram-negative and gram-positive pathogens. The panel runs on the T2Dx Instrument, which is utilized for our current FDA-cleared T2Bacteria Panel and T2Candida Panel. It produces a result in three to five hours. The T2Resistance Panel has obtained a breakthrough device designation by the FDA. This designation has allowed us to expedite discussions with the FDA on analytical and clinical test plans.
In December of 2021, we initiated a clinical trial for this panel and expect to submit to the FDA in 2022. The T2Resistance Panel covers the most clinically important resistant mechanisms found in pathogens that the CDC has listed as urgent or serious threats for resistance. This panel would potentially detect carbapenem-resistant Acinetobacter, carbapenem-resistant Enterobacteriaceae, or CRE, broad-spectrum beta-lactamase-producing Enterobacteriaceae, vancomycin-resistant Enterococci, or VRE, and methicillin-resistant Staph aureus, or MRSA. The CDC has estimated that these infections result in over 590,000 hospitalizations and 25,000 deaths in the U.S. annually. Patients that have symptoms of bloodstream infections are typically treated with empiric antimicrobials. This means that physicians are treating patients without any diagnostic data to support the type of treatment that they're giving. Many of these patients are found to be treated with an inappropriate antimicrobial.
Approximately 46% are not responsive to empiric therapy. Many of these are associated to the fact that many pathogens are resistant to common empiric drugs. Additionally, it's been shown that getting patients on the appropriate therapy rapidly and early during the infection can have a significant impact on mortality. The use of T2Resistance Panel, which provides resistance results within three to five hours with no need for culture, will provide clinicians with needed diagnostic information that can be used to rapidly determine the appropriate treatment for patients. The T2Biothreat Panel detects six biothreat pathogens, all of which have been noted by the CDC to be either Category A or Category B biothreat pathogens. These categories are based on their ability to be spread and the type of severity and of the infection cost.
The T2Biothreat Panel will be an aid in the diagnosis of several serious infectious diseases, including anthrax, tularemia, melioidosis, glanders, typhus fever, and plague. These infections can result in high mortality if patients are not appropriately treated quickly during the infection process. Bioterrorism is a real threat to U.S. security. In 1984, Russia was reported to have used bioweapons during their war with Afghanistan. More recently, in 2001, anthrax attacks where Bacillus anthracis was mailed to U.S. congressional members resulted in 22 illnesses and five deaths. Just last month, the U.S. government warned that Russia may use bioweapons in their war against Ukraine. The T2Biothreat Panel detects pathogens directly from a blood sample with no need for culture. They're run on the T2Dx Instrument and provides results in approximately four hours.
Based on reported data, the panel is expected to be more sensitive than other FDA-cleared molecular diagnostics, which may be important for the early detection of acute infections and rapidly getting patients on the appropriate therapy. The T2Biothreat Panel is currently being evaluated in a clinical trial, and we expect to submit to the FDA in 2022. The comprehensive panel for diagnosis of bloodstream infections and antimicrobial resistance is currently in development. This panel is proposed to be a direct from blood that will detect a combination of genus, species, and resistance markers. This broad array of detections are proposed to detect greater than 95% of bloodstream infections from a single blood sample and present a result in approximately three hours with no culture required.
When we reviewed the proposed panel design with ID physicians and pharmacists, there were overwhelmingly positive comments, and I've listed a few of these comments here on this slide. "I think that it is very exciting technology, and I would be excited to have something like that brought on to my institution, so I could definitely see this advantageous to having available to our sepsis patients." "Is this comprehensive panel helpful to me as a clinician for faster treatment and antimicrobial stewardship? There is no doubt." "I could see broad interest in this. Our hospitalists and intensivists would want to use this." Based on these and other comments, we feel that the comprehensive panel has the potential to significantly change how bloodstream infections will be diagnosed and treated. The comprehensive panel is going to be run on a next-generation instrument that we are developing in parallel.
This instrument will be able to present clinicians with a much larger amount of detections associated with a single blood sample, providing them with the needed information to appropriately treat sepsis patients. The device will utilize whole blood samples. It'll be fully automated and require no upfront manual processing, will be random access, able to process multiple samples simultaneously, and utilize a self-contained consumable for easy loading of samples and disposal after testing. We are developing the T2Resistance Panel, the T2Biothreat Panel, the Comprehensive Bloodstream Infection Panel, and the next generation instrument under a BARDA contract that can provide up to a total of $69 million if all options are exercised. We are excited to advance these products and believe that they will be important contributors in the future.
I will now turn it over to John Sprague to provide a summary of our financials.
Hello, I'm John Sprague, Chief Financial Officer at T2 Biosystems. For the full year 2022, we expect total revenue of $28 million-$31 million, including product revenue of $16 million-$17 million. We expect COVID-19 test revenue to decrease from $9.5 million-$3.5 million, and we expect our sepsis test revenue to double from $5.1 million-$10.2 million. We continue to drive increases in U.S. sepsis test utilization. Test utilization has more than doubled since 2020, and we believe it can reach $20,000 per instrument per year. We expect research and contribution revenue from our product development contract with BARDA of $12 million-$14 million. As Roger noted, we are excited about the products in our pipeline.
We expect to close 60-70 T2Dx Instruments in 2022, and we anticipate the mix will split evenly between the U.S. and international markets. Now, I'd like to turn the session over to T2 management for a Q&A session. Thank you.
Thank you. Ladies and gentlemen, at this time, we will conduct our question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. To remove yourself from the queue, you can press star two on your telephone keypad. Once again, to ask a question, press star one on your telephone keypad. Our first question comes from Mark Massaro with BTIG. Please go ahead with your question.
Hey, everyone. Thanks so much for putting this nice Analyst Day on today. I guess if Dr. Snyder is still on, I wanted to ask, you know, he talked about using T2Dx across multiple parts of the hospital system, you know, obviously emergency department, ICU, I believe oncology and transplant. Would it be possible for him to comment how many systems he's using and maybe what it took to go from one to maybe more than one? Maybe just, you know, does he have any intention on adding additional T2Dx systems to his system?
Hi, Mark. This is John. Thanks for the question. I'm gonna ask Dr. Ahuja to take that because Dr. Walsh and Dr. Snyder are not on for the Q&A.
Okay.
Hello. This is Aparna. Dr. Snyder, as he shared with you, worked very closely with different stakeholders to show the impact of the system, the panels and the instrument on the clinical outcomes, and that's how he is working on taking it to various different locations. Right now, I would not be able to comment on his behalf as to how many instruments he is planning to have there, but I can tell you that he is very confident, and he's got huge support, like he told you when he was answering the questions, that he's got huge support from ID docs and various stakeholders across the hospital after seeing the impact. That's what I'd heard from him even when he started.
The more expansion of this, the clinical utility roles of me and my medical affairs team is to. I hope I answered your question. Not completely?
I guess, you know, my second question is really around the strategy of converting all of the T2Dx systems that were placed during COVID-19. You know, my understanding is that there were some relatively small portion of the installed base for COVID-19 that has started to move over to sepsis. But can you maybe just speak to the strategy, the conversations? I mean, obviously in many parts of the country, we are seeing COVID-19 cases decline a little bit. I would like to think that that should free up some capacity maybe to shift some of those instruments from COVID-19 over to sepsis. I'm curious if you have any updates there.
You know, maybe for Brett, you know, what is the strategy to try to convert as many of those as possible from COVID-19 to sepsis?
Yeah, great question, Mark. Brett will take that one for you.
Yes. Thank you, Mark. I appreciate that. I think you accurately characterized the scenario. I mean, we've certainly seen, you know, the COVID-19 impacts were still quite significant through the end of the year and frankly, even into the first quarter of the year. We do, yes, as of late, particularly, certainly our efforts, as you heard, are very focused around, you know, moving these to sepsis. We're really seeing from the market's perspective a much more sort of I'll call it an open willingness, maybe a beginning of the transition away from the COVID-19 mindset towards that. We've got a number of targets with that.
It's an all-in effort, both from the sales team's perspective as well as you heard Aparna mention from, you know, the medical affairs colleagues perspective. So, yeah, I mean, that's certainly a primary area of thrust and certainly one that we expect is, you know, gonna begin to bear fruit here as we've kind of gotten to this point and hopefully gotten COVID-19, you know, at least largely behind us from the focus, you know, at the hospital level.
Okay. I wanted to ask another one. I don't know if you have this, but you know, you guys do expect roughly a 50/50 split in placements this year between U.S. and O.U.S. Do you have a sense for what the pull through per box might look like O.U.S.? You know, is it similar or is it going to be perhaps a little bit lighter? I guess it probably depends on the size of the system and you know, where it's deployed.
Mark, I would say that they're similar. Keep in mind that we did not sell COVID-19 outside of the U.S., so I wouldn't include that in any of the modeling.
Yeah. Okay, that makes sense. Would also love to hear, you know, obviously you guys did a nice update on your pipeline, but, can you just remind us on the next-gen T2Dx system and the expanded bacteria panel, what are the key hurdles that need to be tackled here? You know, how soon do you think we could see, you know, either of these launched in the U.S. market?
Okay, I'll start with that. Then Roger or Alec Barclay may wanna add some color to it. I think as you heard from Roger, we have four programs running in parallel, and they're all within the BARDA contract or under the BARDA contract. That's the T2Resistance Panel, the T2B io threat Panel, and then our next gen instrument and next gen comprehensive panel. Our objective, obviously, is to commercialize those products as soon as possible. The priority, because we have two of those products in U.S. clinical trials, is to complete those clinical trials and file the submissions, both of which we plan to do this year. It's worth noting, and Roger didn't mention this in his presentation, that the negative testing arm of the T2B io threat Panel is completed, and that specificity data looks very promising.
The next gen instrument and the comprehensive sepsis panel, which obviously are going to dramatically expand our ability to detect fungal pathogens, bacterial pathogens, and antibiotic resistance genes, are in the development stage, and we're super excited about those. I think the thing that's really exciting is that we believe that the comprehensive panel for the detection of bloodstream infections and antimicrobial resistance will replace most blood cultures for patients at risk of sepsis. Dr. Snyder talked about how today our products are used in concert with blood culture because we're detecting these resistant pathogens, ones that clinicians would want to know if the patient is affected with immediately. When we launch our next gen products, our positioning is gonna shift from an adjunctive test to a primary test to detect sepsis-causing pathogens and antibiotic resistance genes.
I think that's an important first step that we're taking with the pathogens that we detect, which we believe are incredibly valuable. We heard that from Dr. Walsh and Dr. Snyder. Our next generation products, we think, are going to dramatically impact the blood culture workflow and potentially replace most blood cultures for patients at risk of sepsis. Roger or Alec, do you want to add anything else on the hurdles related to the panel or the instrument?
Yeah. I think, you know, when we think about developing a much more comprehensive panel, a panel that will provide a significantly larger number of detections from a single blood sample, I think the biggest hurdle is, you know, deciding what's gonna be on the panel, how we're gonna push for the sensitivity to make our panel as sensitive as possible and to maintain the quality that we have in our current panels, so the T2Candida and T2Bacteria Panels, as far as our ability to detect and have sensitive detection direct from a blood sample. That's really what we've been focused on and pulling that together on this new platform.
Okay, that's super helpful. My last question, probably for Brett again. You indicated that I characterized the COVID-19 environment fairly accurately, I guess. Can you just give us an update on the number of reps you have in the field? I think it's somewhere around 15 or so. And then, when were they trained? You know, are they all starting to contribute or, you know, are they fully loaded, if you will, and trained? And then maybe can you just expand a little bit more on what you're seeing? You know, do they have pretty good access across the country? You know, is it more than 50% in-person hospital access? And maybe can you provide any commentary around your funnel for the year?
Sure, Mark. Yes, to start with the actual numbers of the organization, we had made the decision later in 2021 to expand to 20 territories. We currently have all but really two of those filled, and we're very close to filling the final couple. Yeah, I mean, the team is, you know, as I said, we're 90% plus there from the U.S.'s perspective. Additionally, as I mentioned, we've certainly got management in place with that group. Yeah, I think that from an effectiveness perspective and getting to your question about training, it's always a sort of a, I guess, if you will, combined over time because clearly people start at various times.
I would say that, you know, the team is about 75%, I'd say, fully trained at this point. We added some people here early in the year that are still, you know, sort of coming up to speed. From an effectiveness perspective, I think one thing that we've seen. I think it's a combination of the people that we're hiring with the familiarity and the ability they have to access hospitals. But also importantly, as I mentioned in the presentation, I think we've really doubled down heavily with this training program and the follow-on to it. It's provided a lot of very, you know, concrete things that we can fall back on and that frankly, that we use from a language perspective to monitor deals.
It's helped the sales team, I think, get up to speed even more effectively. Very encouragingly, some of the, you know, late Q4 and early successes we've had this year were actually done by people who really were relatively new in the chair. I think that gives us a lot of, you know, very sort of enhanced bullish attitude about how quickly the team can drive the numbers as we go forward. They're up to speed a lot more quickly than we may have thought. That's, I think, pretty well gives you a flavor for that.
I think from an observations perspective and from a planning as we're going forward, I mean, clearly, we've you heard us say it before, without going into anything specifically on that, we feel very, very good about our funnel for this year. I think a lot of the activities we had at the end of the year and early this year is we feel like are really, really coming, you know, gonna bloom very nicely for us here as we go forward in the quarters of the year, so.
Okay. Thanks so much, guys.
Sure.
Thanks, Mark.
Thank you. Our next question comes from Kyle Mikson with Canaccord. Please state your question.
Great. Thanks, guys, for the questions, and thanks for the data today. Very well done. I guess on the topic of using the instrument across the hospital and in light of the next gen instrument to be launched in the near term, I guess I'm just wondering if the decision to order a system could that shift to you know like a multi-departmental or like enterprise-level decision rather than a solely department-based choice? Or maybe vice versa for that matter. Just was wondering if you could clarify. Look, I'm just curious about the kinda medium-term evolution given the potential flexibility of you know the platform. Thanks.
Kyle, just to understand, is your question will the decision-making evolve from single departments to multiple departments as we evolve from the current T2Dx to the next gen? Just wanna make sure I understood it correctly.
Exactly. That was great. Yep.
I think it would be fair to characterize the decision-making process today as multidisciplinary and across the hospital. Generally, and I think this is reflected in the team that we built in our medical affairs group, we're dealing with laboratory professionals, medical doctors, typically ID docs, and pharmacy. Those are the three main, let's say, target groups that we speak to. Within a hospital, the decision-making process is typically broader than that, and it usually comprises an antibiotic stewardship committee or a sepsis committee, depending on what the hospital has in place. It's pretty broad already. I wouldn't anticipate that it gets more broad.
What I would anticipate is that between now and when we launch our next generation system, we will have employed or deployed, if you will, more KOLs, and we will have built a stronger war chest of clinical and in some cases, economic data to support our value proposition, which will help drive awareness and greater adoption between now and when we launch our next generation system. I think that the progress that we make with the T2Dx and our current panels is gonna really facilitate the adoption and traction of our next gen platform. That's the way I think about it.
All right. That was helpful, John. Thanks. You know, I appreciated the comparisons to, like, traditional blood culture, other kind of methods out there, for the kind of instrument. I guess, though, like, obviously, you know, your box is clearly faster than others. How does, like, you know, some of the other metrics stack up for some of the, you know, vendors of similar or like adjacent tests or instruments out there? You know, not that they're all kind of sepsis, but like BioFire, Accelerate, Luminex, things like that. I mean, it was clear to me, some of the definitive top characteristics of like a platform, but maybe what are some of the others and why does, you know, T2 kind of outpace those and kind of stack up against the rest? Does that make sense?
Sure. Well, all of those companies or technologies that you mentioned are post blood culture technologies. They're going to first rely on a positive blood culture in order to identify species or resistance in cases where they do. They're limited just out of the gate by blood culture. Blood culture has two significant limitations. One is that it takes a long time, and as Dr. Walsh described, this patient's status declines pretty quickly, and if they're not on targeted therapy quickly, then some of that damage is unrecoverable. I think that's important to note. It's not just about saving the patient's life, it's also about saving the patient's quality of life. It's a discussion I've had with Dr. Walsh before. The second limitation of blood culture is poor sensitivity.
I think it's well known and well documented that a single blood culture has sensitivity of somewhere in the range of 60%. That's 60. I mean, as a diagnostic tool, that's not something I would wanna rely on in a life-threatening situation. That's the current standard of care, and that's why we're so passionate about changing it.
All right, perfect. Maybe going to Brett. There was great commentary on the kind of commercial expansion in the U.S. and internationally as well. I was just wondering what the steps are to kind of expand further internationally. I heard the, I think three business managers in a few different regions. I mean, what's next there? I mean, I feel like this could really develop into an interesting, you know, opportunity for you. I guess ultimately, like, do you see yourself ever going direct O.U.S. if that becomes like a material, you know, growth driver and a larger portion of revenue?
No, that's, I really appreciate that question. I think that we're very excited about our opportunities internationally, as you know heard me say in the presentation. Yeah, I mean, you know, we've currently expanded. We had a person dedicated in Europe who we were really leveraging in most of the other regions, and we obviously had another that was based in Europe, but still helping to sign up with some of the early activities we had even in the Asia markets. You know, we had added another resource in the Middle East to focus in that area.
Earlier this year, we did bring in, as I mentioned, a focused international business manager specifically for Asia-Pacific, but also because he has a lot of great experience there, we're leveraging him for Latin America. Lots of years of experience. Has, as I mentioned, you know, really great acuity and understanding of those markets and really all of the key markets. They're not only some of the, say, the smaller Southeast Asia countries, but also the big ones like China, Japan, those types. Yeah. I think the idea behind this is that, you know, these folks, you know, hence the title, they're business managers, they're principal...
They're principally commercial drivers, but also come with, you know, experience across the board to be able to deploy all of our resources there, you know, service and support, you know, etcetera. So yeah, I mean, the plan is to continue to expand that. I mean, we've already, as you've seen, probably certainly over the last couple of months, we've had successes continuing to add other partners in those markets. And we've clearly got a number of additional targets, not only in Asia but also in Latin America. We were able to secure a entryway into Mexico, and that was just the start. We've got a number of other, you know, Latin American markets that we're looking at. So yeah, I believe this year I'm gonna put a number on it.
We certainly have our target list, but we feel really bullish that we're gonna continue to see a significant expansion in the international markets, so.
All right. That was great, Brett. Thanks a lot for that. I guess I'll ask another, and then I'll hop off. Maybe broadly about the technology. What's the path, I guess, to become the standard of care or like a, I guess, first line test and kind of replace what blood culture does today? What has to happen and how long could that take for T2's workflow and kind of user experience to be independent of blood culture?
Kyle, I'll start and then perhaps Ahuja may wanna or Aparna may wanna add some comments to that. First thing is education. We continue to make investments in clinical and medical affairs and that is to educate the community. We are going to build a scientific advisory board and part of the effort there is a peer-to-peer educational aspect. We continue to use and work with partners to educate the community, whether it be at scientific sessions or trade shows that we attend, and our attendance has significantly increased over the last 12-18 months. There's a big educational aspect of it and that is being worked at the field level between and with our medical affairs team and our sales team working together to educate and drive adoption and then later increase test utilization.
I think that's a really important part of the foundation that we're building. We are also making sure that we have the right key reference accounts, so that if one of our reps is in a particular geography and a hospital says, "Are they using it at XYZ reference account?" We can say yes and immediately remove that barrier. We have a number of really good key reference accounts already, but we are expecting and planning to expand that as we go through this year and next. From a targeting perspective, we are targeting large accounts. We obviously mentioned Mayo and Baylor, which we were able to bring into the T2 table in the last year.
We have a number of other targets, but we're also targeting regional access hospitals and critical access hospitals, kind of the medium-sized hospitals in the market, so that while some of them have longer sales cycles, we also can attack the market where there are shorter sales cycles. I will tell you today, our record from start to close is six days. That's not an expectation that we should have for every instrument, but there are cases where we're able to take an account from an unqualified lead to a close very, very quickly, and that's by targeting the right type account and by leveraging relationships that the people in the field have and brought to T2, the new RAMs and the medical affairs specialists. I'll start with that. Aparna, would you like to add anything about driving standard of care? I think you're on mute.
Sorry. Apologies. Thank you. Thank you, John. You covered almost everything. I would just add one is that working very closely with key opinion leaders, which may or may not be the users and will become I would say potential users, existing users, to be able to have them rally around the change in the standard of care. They need to believe in that and help because these guidelines are actually decided and implemented by various professional associations where these KOLs are part of these associations. We all as medical affairs team is working on working with the KOLs. Right now, I can say that we have, within the last year, been working with about 200 of the HCP and KOLs, and as John mentioned, the scientific advisory board.
One of the key things that we'll be driving through this would be generating the clinical data to show that changing the standard of care will lead to better clinical outcomes and better health economic outcomes. Data, clinical education and the KOLs supporting this would lead to the change in the standard of care. I would end at that.
Okay. Makes sense. Thanks for that. All right, I appreciate it, guys. Thanks again.
Thank you, Kyle.
Thank you.
Yes.
Thank you.
Thank you. Just a reminder to ask a question, press star one. Our next question comes from Ben Haynor with Alliance Global Partners. Please go ahead.
Good day, guys. Thanks for the presentation and thanks for taking the questions. I guess first off for me, you know, Dr. Snyder as kind of an early adopter mentioned that his institution, you know, kinda initially offered the T2 testing to a limited number of units or departments, and then, you know, it sounded like it expanded quite a bit within the institution. But it also sounds like the situation now that you're running into is that you've got a lot more broad-based support when you're initially making contact with the customer and getting contracts signed.
I guess as a stance today, what's kind of the mix of the, you know, kinda toe hold, land and expand, you know, get a system in and expand within the hospital versus, you know, okay, let's do broad-based adoption right off the bat? I mean, is there anything you can share on that front?
Brett, would you like to talk about the commercial strategy on account closes and expansion? How would you-
Sure. Yeah, sure. Yeah, Ben, so we're. I mean, our efforts from a targeting perspective and, you know, what we're as we probably mentioned a little bit in the presentation, we're. I'll call it a bit of a two-prong to some extent. I mean, we're obviously focusing on, you know, identifying and driving things with new accounts, and clearly the sales team is focused heavily on that, you know, obviously to expand our instrument install base. At the same time, you know, as we mentioned, we've got a significant base of instruments that are there, in sort of a combination of things.
Some of them are, you know, certainly existing sepsis accounts that, you know, we're obviously working, you know, with those accounts to continue to further drive adoption and test volumes. Then also, there's the, I'll call it the COVID-19 part of this, which, you know, we've obviously identified those accounts that brought in our instruments for COVID-19. I guess, you know, that's really sort of our strategy, if you will, is to really focus along all of those lines there. You know, as John mentioned earlier, you know, we're sort of resourcing ourselves to be able to drive all of those.
Clearly, the sales team on the front end and then an integrated effort of the sales group, you know, with the medical affairs team, you know, as we get into, you know, those more clinical discussions into, you know, into the accounts and trying to expand within it. That's really the strategy. I think where we're benefiting, as you would expect from all of this, is that, you know, having greatly expanded the team and greatly expanded the footprint and the outreach has, you know, clearly allowed us to obviously target a much wider array of accounts, but also to be able to, you know, on the front end, cover more ground, if you will, you know, on these discussions in the other areas.
I think that's really the way to characterize it.
Okay. That makes sense. That's definitely helpful. One of the things that Dr. Snyder mentioned that I was curious about, he said he wanted to get you know, dedicated phlebotomist draws rather than the nurses doing that. I was just curious, you know, why is that? Maybe that's specific to his institution, but was just curious about that. Maybe since he's not on, it's not answerable, but Aparna, do you have a sense about that?
Yeah. I think you partially answered the question yourself also when you asked that question. Yes, it would be hospital and lab specific whether the collection is done by a nurse or phlebotomist. However a gnostic of T2 Biosystems, it is known that phlebotomists always do a better draw because that's what they're trained on, and that's a known fact. That is something that if you want the collection to be like, this is a very critical test, we all understand that. Having the right sample, right volume of sample drawn is critical. To avoid, if I can use that terminology, the pre-analytical issues, it's very important to have a very well-trained blood draw system, which would typically be a phlebotomist, although some hospitals and lab would have nurses draw it off the floors, too. Did that.
Okay.
Mm-hmm.
No, no, that's definitely helpful.
Mm-hmm.
You know, just on, I guess, on the collaboration with BARDA. This is something that I guess I wanted to offer a little bit. You know, clearly, BARDA's funding a great deal of the R&D for your pipeline. Can you give us a sense of, you know, what proportion of the collaboration projects within the pipeline BARDA actually is funding? Because it seems to me that's a fairly significant portion.
Yes, I'm happy to take that, Ben. BARDA is funding up to $69 million if all the options are exercised. As you recall that contract was initiated, I believe, in September 2019. We just completed option 2A. We just announced option 2B. Hopefully, there will be a 3, 4, 5, 6 as we continue to advance these programs. Underneath that BARDA contract umbrella are four programs, T2Resistance Panel and T2Biothreat, both of which are in clinical trial, both of which we anticipate completing and filing with the FDA this year.
Also under that BARDA contract umbrella are the next generation instrument and the comprehensive panel for bloodstream infection and antimicrobial resistance. All four of those programs are funded under the BARDA contract. What % BARDA pays depends on the statement of work within each of the options. I would just generalize by saying it's somewhere between two-thirds and three-quarters of the cost for each of those programs.
Again, it varies a little bit depending on which option and where we are within the scope of work of each option.
Okay, great. I don't know what my odds of getting this question answered are, but you know, I think on the Q4 call we were about six weeks in to the year, and I think you had eight contracts already signed in the U.S. You know, any update on how those early successes have continued?
Well, I applaud your question, Ben. What I would say about that is we're not announcing our Q1 results yet. We would do that in its due course. But I think what you did hear from Brett was confidence in the sales team, both the U.S. team as well as the international team, and confidence in the sales funnel and the way that our team is managing that sales funnel. At this point, that's what I would just reinforce.
Okay. Fair enough. Had to try. All right. Well, thanks a lot, guys, and a good presentation.
Thank you, Ben.
Thank you, Ben. Yeah.
Thank you. There are no further questions at this time. I'll turn it back to Mr. Sperzel for closing remarks. Thank you.
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Thanks. That concludes today's webcast.