Good morning, everyone. Thank you for joining us here in New York on the webcast and in person. Today, Dwight Egan, Chief Executive Officer of Co-Diagnostics, will discuss the company's new collaboration with U.K.-based ReadyGo Diagnostics, the manufacturing capability supporting future scale, and the progress underway at CoSara in India. A few housekeeping items before we start. Today's presentation is being recorded, and a replay will be available in the investor relations section of the company's website. Following the presentation, we will take questions. Please note that certain statements made during today's presentation that are not historical facts are forward-looking statements. These include statements about product development, the ReadyGo collaboration, regulatory submissions and timing, manufacturing capacity, market opportunities, and commercialization. These statements involve significant risks and uncertainties. Actual results may differ materially, and there can be no assurance that anticipated results will occur on a timely basis or at all.
Important risk factors are described in the company's filings with the Securities and Exchange Commission, including its annual report on Form 10-K filed March 31st, 2026. Co-Diagnostics undertakes no obligation to update or revise these statements. The Co-Dx PCR platform is subject to FDA review and is not currently for sale. The blood-based applications discussed today remain in development and require further validation and applicable regulatory authorization. This presentation is not an offer to sell or a solicitation to buy securities and should not form the basis of an investment decision. Today's presentation also includes information regarding other companies, including public reported market size and valuation data. That information is derived from public sources and third-party estimates that we have not independently verified. It is presented as market context only. It is not a projection, forecast or indication of Co-Diagnostics' own results, revenue, or valuation.
In addition, the company's collaboration with ReadyGo is non-exclusive, early-stage development collaboration. Nothing in today's presentation should be understood as a representation that blood-based testing on the Co-Dx PCR platform has been validated or authorized for diagnostic use. With that, I will now turn the presentation over to Dwight. Thank you very much.
Thank you, Rob, and thank you everyone for your interest in Co-Diagnostics. I would like to begin with the problem we are working to address because it explains why we are pursuing this opportunity. The figures in this slide illustrate the urgency. As of the World Health Organization's most recent situation report, the Democratic Republic of the Congo has reported 6,757 confirmed cases and 3,267 deaths. A case fatality rate of roughly 48% across 61 health zones in six provinces. The World Health Organization has described this as the second largest Ebola outbreak on record, and one that is spreading substantially faster than previous outbreaks. This is not a problem that stays in Central Africa. Imported cases have already been reported in Germany and in France this year. Outbreaks that begin where diagnostic infrastructure is thinnest do not stay there.
For us, the central question is how to make molecular testing more accessible in the places where response is needed. A test has greater practical value when it can fit the setting where patients seek care. That view is reinforced by the organizations that fund outbreak response. In our conversations with global health foundations, the message has been consistent. The world does not need another centralized laboratory test. There are plenty of those. What is missing is a molecular test that can reach the remote settings where patients actually present and return a result on site. That has been the objective behind our investment in decentralized PCR. We are developing a platform to bring molecular testing closer to patients, including communities with limited access to centralized laboratories.
As we discussed on our second quarter call, we completed an extraction-free proof of concept study for Bundibugyo virus detection using diluted plasma on the Co-Dx PCR Pro. That was an important early demonstration of the platform's potential beyond swab-based testing. There is more development work to do, but I want to be direct about why we are pursuing this, because the significance is considerably larger than Ebola. Until now, the Co-Dx PCR platform has been designed around swab-based samples, nasal swabs, tongue swabs. Establishing blood as a validated sample type would open the platform to an entire category of blood-borne pathogens that a swab simply cannot reach, HIV, hepatitis B, hepatitis C, and others. Each of those applications would require its own development, its own validation, and its own regulatory authorization.
But the size of the opportunity in front of this platform changes materially with the introduction of blood-borne pathogen detection. Put another way, Ebola is where we are proving this out. However, the larger opportunity is the ability to run blood-based molecular testing into a doctor's office or a rural clinic at the price point of our instrument, rather than sending the sample to a centralized laboratory. The next step is to determine how sample preparation and our platform can work together in a practical workflow, and that is where ReadyGo comes in. We are collaborating with ReadyGo Diagnostics, a U.K.-based company, to evaluate a new approach to blood-based testing on the Co-Dx PCR platform, initially focused on the Ebola detection. ReadyGo developed a field-capable sample preparation technology, and they concluded that they needed a molecular platform that could actually operate where their product is used.
They identified the Co-Dx PCR platform as a viable platform. To give you a sense of the setting we are both building for, India alone has roughly 650,000 villages with no practical access to molecular diagnostics of any kind. ReadyGo brings its GoCollect sample preparation technology. We bring the PCR platform, the test cartridge, and the connected infrastructure that can support reporting and outbreak response. We recently entered into a material transfer agreement to support this work, which we disclosed in the Form 8-K filed yesterday afternoon. Over the past several days, we have taken delivery of ReadyGo's materials and devices, and that hands-on evaluation work is now underway. This is a non-exclusive development collaboration, deliberately so. Both companies remain free to pursue their own grant funding and their own commercial paths, which we consider an advantage rather than a limitation.
We rely on the inherent strength of our accessible and affordable platform. The work builds on our earlier plasma proof of concept that gives us a starting point, while the combined GoCollect and PCR Pro workflow still needs to be demonstrated and validated. What makes this strategically interesting is the potential to expand the application supported by the platform. If we can establish a suitable blood-based workflow, we believe that could create opportunities well beyond the initial Ebola program. Let me walk through the sample preparation component first so you can see how the pieces are intended to fit together. This slide shows the GoCollect capillary collector and GoCollect plasma. Together, they address the preparation of a blood sample for downstream molecular testing. The collector combines capillary blood collection with sample conditioning chemistry. The plasma device then separates plasma from whole blood to provide a prepared sample for testing.
One feature worth calling out specifically, the collector's chemistry is designed to inactivate the virus at the moment of collection. In a field setting, handling live Ebola samples is itself a serious constraint on who can perform tests and where. A sample that is rendered safe at the point of collection changes what is operationally possible. We are evaluating two possible workflows. In the simpler case, a modified capillary collector could feed our test cartridge directly. The more likely near-term path uses GoCollect Plasma to separate plasma from whole blood, which then goes into the cartridge. Both require real R&D work, and determining which one prevails is precisely what this collaboration is meant to do. We need to establish compatibility across the complete process, including the prepared sample, our chemistry, and the test cartridge. Successful work on an individual component doesn't automatically establish the performance of the combined workflow.
The development objective is a workflow that can be practical at the point of need. Reducing the infrastructure required for sample preparation could help us reach settings that are difficult to serve today. That's why we view sample preparation as an important part of the commercialization strategy. The customer needs a simple, safe, and effective process from collection through to result. Once the sample is prepared, the next component is molecular detection on PCR Pro. The Co-Dx PCR platform brings together the instrument, a consumable test cartridge, and connectivity. Our objective is to make PCR more accessible while connecting the result to the people who need it. In this proposed cloud-based reporting and visualization application, blood-derived samples would be tested using the Ebola assay under development. The results are uploaded immediately if a Wi-Fi or cellular data connection is available.
If no internet connection is available, the results are temporarily stored on the connected phone or tablet, then uploaded later, as soon as a connection can be established. The instrument and cloud illustration here shows how that data could then be visualized, thus immediately connecting local testing in support of a broader response. The dashboard on this slide is illustrative and uses simulated data. It is not a display of actual Ebola testing performed by our platform in the DRC. The concept is straightforward. Each individual test result can inform a local decision, while connected reporting can help authorized officials to understand and respond to testing activity across multiple locations. This digital architecture has been part of our strategy from the beginning. Our investment in the mobile application and secure cloud infrastructure supports reporting, remote system management, and access to diagnostic information.
As adoption develops, we also see potential for analytics and artificial intelligence to help make that information more useful. Those opportunities depend on validated capabilities and responsible use of the data. Commercially, our aim is to build an installed base that supports ongoing test use. A broader menu could give customers more reasons to use the platform and create recurring demand for consumables over time. The next slide brings sample preparation testing and connected reporting into one view. This is the complete approach we're working toward. Prepare a blood-derived sample, perform molecular testing at the point of need, and connect the information to support a well-targeted and scaled response. ReadyGo's technology addresses the sample preparation step. Co-Dx PCR Pro is the detection platform. The mobile application and Co-Dx's cloud are intended to make results available beyond the instrument itself. Ebola is our initial focus for the collaboration.
Over time, successful blood-based sample preparation could support development of additional assays and expand the settings in which the platform can be useful. There's also a near-term reason to start with Ebola, specifically. NGOs, ministries of health, and donor organizations responding to this outbreak have an immediate need for decentralized testing. That's the connection to our long-term business model, expand the useful applications of the instrument, support adoption, and build repeat test use as products achieve the necessary milestones. To support that model, we also need to manufacture consumables efficiently and consistently. Let me turn to the progress we're making there. As we prepare for commercialization, we're investing in the manufacturing processes needed to support increasing test volumes. The comparison shown here contrasts our manual lines used to develop the system and our automated work cell, which is already operating. Automation reduced cycle time from 30 seconds to 16 seconds.
In the same comparison, it shows production increasing from 757 cartridges to 2,000 cartridges, or roughly 74% more cartridges produced on a single work cell. The difference that matters most, though, is labor. A manual cartridge line requires roughly eight people to operate. The automated line requires approximately three, with future reductions in the plan. These gains greatly facilitate scale-up, with each automated work cell moving twice as fast with half as many people. These are process results. The commercial benefit will depend on the volume we produce, utilization of the equipment, and the cost of operating at scale. We believe automation can help us support growing consumable demand without having to increase manual work at the same pace. That is important to the economics of an installed base that uses tests repeatedly. It also directly supports our international strategy.
Our joint venture model, CoSara in India, CoMira in Saudi Arabia, depends on being able to transfer a production process into another country and have it run reliably there. A line that requires eight trained operators is difficult to replicate. A line that requires two is a process we can hand over. Automation is what makes the joint venture model scalable rather than simply local. We'll show two short videos to make that progress more tangible, beginning with the manual process. This first video shows the manual production process and the hands-on work involved in manufacturing our test cartridges. As you watch, the important point to keep in mind is the number of operator steps involved. This gives you a reference for the automated investment and the automation investment that we're making. That process has supported our development work.
The next video shows the automated approach we're advancing to support greater production scale. Here, you can see the automated production equipment and how we're bringing more of the process into a repeatable sequence. The commercial objective is to produce more usable cartridges efficiently as demand develops. We'll continue refining the process as we prepare for future manufacturing needs. This investment also fits the work we've discussed through CoMira in Saudi Arabia, where we have been preparing for future technology transfer, and through our established presence in India. India is a good place to see how our manufacturing, clinical, and commercial work come together. Let me turn to CoSara. CoSara represents nearly 10 years of accumulated investment, manufacturing facility, regulatory approvals, a distribution network, and an established customer base that is only now arriving at the point where it can carry new products.
We have been building it quietly for a decade, and we believe it is significantly underappreciated. That foundation matters as we work toward commercialization of Co-Dx PCR Pro. Local presence helps us understand customer needs and prepare to support products in the future in the market. CoSara has the capabilities and product opportunities beyond Co-Dx PCR Pro. Its assay business and expanding in-house production give us a broader base on which to build. Some evidence of that momentum, since the beginning of this year, we have shipped 24 additional PCR instruments into India, expanding both our installed base and our customer relationships across the country. CoSara's oligonucleotide synthesis laboratory is now in production, supporting R&D and commercialization activity in the region. We believe that combination is important. A local organization with experience in the market, supported by technology and manufacturing capabilities that continue to develop.
To put that work in context, let's look at the region CoSara is positioned to serve. The estimates on this slide size the diagnostic market across India and its neighboring countries at approximately $13 billion, with India accounting for roughly $11.4 billion of that. Point-of-care diagnostic spending in the region is estimated to be growing at about 8.5% annually. These figures describe a broad regional opportunity. They cover different diagnostic categories and should be treated as market context rather than a precise measure of the addressable market for Co-Dx PCR Pro. Our commercial focus is more specific applications and settings where accessible molecular testing can meet a practical need, supported by local product authorization and an effective route to the customer. Tuberculosis is an important starting point for that work in India.
The workflow we're developing is intended to support testing closer to patients, including settings where a centralized laboratory model can be difficult to access. CoSara gives us a firm base from which to pursue that opportunity. We can combine local manufacturing and relationships with the platform and consumable capabilities we've been developing. A large market creates room to participate, but adoption will depend on performance, usability, pricing, and execution. The next slide gives some context for how investors and customers are looking at this category. I want to spend a moment on this slide because it goes to a question that we get asked frequently: Is decentralized molecular diagnostics really a market or is it an idea? Molbio Diagnostics is a decentralized molecular diagnostic company based out of India and founded more than a decade before we began our work in the region.
Earlier this year, it completed an initial public offering at a valuation of approximately $1.05 billion. That offering was reported as roughly 70 x oversubscribed. To date, the company has deployed more than 12,500 devices across more than 90 countries. We see this as strong validation of the market we are entering by the customers, the regulators, and now by public investors, and it has been validated in the exact region where CoSara has spent the last 10 years building. Our Co-Primers technology has also been validated in the market. As a reminder, our tests were distributed in more than 50 countries during the pandemic to centralized labs. Molbio's presence is also principally in centralized and near centralized laboratory settings at instrument price points that, in our assessment, are difficult to justify at India's primary healthcare centers. We designed Co-Dx PCR Pro for that gap specifically.
Simple enough for non-laboratory staff, accessible at a price appropriate to a clinic, and connected so that a result does not stay on the instrument. We think the Co-Dx PCR Pro is a better fit for this market in every way. The clinical studies underway in India are an important part of demonstrating this. Let me show you the workflow we're validating. Our tuberculosis clinical studies in India are evaluating the complete decentralized workflow, beginning with the sample and continuing through preparation, PCR testing, and reporting. The process shown here starts with swab sputum or a tongue sample, followed by the heat-based sample preparation step. The sample preparation platform, which we have developed, is an essential part of the TB workflow, and it is also designed to help extend PCR across future applications, where preparing the sample appropriately is critical to making the test useful.
The prepared sample then moves to Co-Dx PCR Pro for multiplex real-time PCR testing. The mobile application and cloud database complete the reporting concept. The commercial objective is a workflow that can be practical for the settings in which it will be used. As of this week, the team has collected more than 500 of the approximately 600 samples required for this phase, including all the positive TB samples we needed. Collection of the remaining negatives is now continuing. We are targeting completion of this study phase this month. That remains a target subject to study progress and completion of the necessary work. These studies are intended to generate evidence supporting regulatory submissions and commercialization. Completing sample collection is one step in that process. The data will need to support the intended use.
Our planned regulatory work includes submission to India's Central Drugs Standard Control Organisation, or CDSCO, and to the World Health Organization's Expert Review Panel for Diagnostics pathway, known as ERPD. Timing and outcomes remain subject to the requirements of those processes. Two pieces of external context are worth noting here. Recent WHO guidance recommends near point-of-care molecular testing for tuberculosis, including tongue swab sampling, which is precisely how our MTB assay and our platform were designed. This past quarter, we were invited to participate in a manufacturer partner in a UNOPS Global Implementation Workshop on Near Point of Care TB Diagnostics in Bangkok, alongside national TB programs, donors, and technical agencies representing 21 countries. We read that as a recognition of where TB diagnostics is heading. In addition to the clinical program, CoSara is strengthening the capabilities needed to support its products and serve additional customers.
That focus is our final operating update. CoSara is expanding its in-house capabilities in master mix, oligonucleotide production, and sample preparation. Each supports CoSara products and creates opportunities to serve additional applications or customers. Master mix contains key components used in PCR testing. Developing this capability internally can give CoSara more control over an important input to its assays and reduce reliance on outside suppliers. Oligonucleotides are another essential component of our assays. In-house synthesis supports faster development and lower cost production, with the potential to supply other research and commercial customers as well. There is a third piece I want to add because it is a straightforward commercial win. CoSara has developed its own in-house extraction kit. Historically, when a customer bought our assays, we had to refer them elsewhere to buy the extraction kit needed to run them.
We were sending both revenues and a piece of the customer relationship to a third party. We can now supply it ourselves. What I want investors to recognize is the business we're building in India. CoSara brings together local capabilities that can support assay development, manufacturing, and customer needs over time. Taken together, these investments give us a stronger foundation for commercialization. I'd like to close by connecting that progress to the broader strategy we've discussed today. When you look across today's presentation, I hope the connection between these initiatives is clear. We're working to expand what the platform can test, what the workflows that is practical, and build the capacity to support its use. Our ReadyGo collaboration is an opportunity to advance blood-based sample preparation. Successful development could support a broader assay menu and extend the potential usefulness of Co-Dx PCR Pro.
Our connected infrastructure is designed to make diagnostic information available where it can support decisions. Automation is helping us prepare to produce consumables more efficiently as demand develops. In India, CoSara combines an established local presence with clinical work and expanding manufacturing capabilities. That gives us a foundation for pursuing the opportunities we've outlined. Our U.S. regulatory program remains another important part of the strategy. As we reported on our second quarter call, we submitted the Dual 510(k) and CLIA Waiver by Application for our Co-Dx PCR Flu A/B & RSV assay. The platform remains subject to FDA review. Ultimately, our objective is to convert this work into authorized products, customer adoption, and recurring test use. That's where the long-term commercial value needs to come from. There is important work ahead, and we remain focused on completing it.
We appreciate the commitment of our employees and partners and the continued support of our shareholders. Before we go to questions, for those of you who are here in the room, we have a Co-Dx PCR Pro and test cartridges with us, and we'd be happy to walk you through the instrument after we finish. Thank you for your time today, Rob. Let's open the discussion for any questions.
Hi. Thank you so much for the informative presentation today and for taking my questions. I wanted to ask if there is any additional engineering to the cartridge itself that would be required to accept the blood-based samples, or if it's purely the prep that allows it to work with the same sort of cartridge?
Thank you for that question. We put a cartridge in front of your seat there so you can take a look at it up close. You'll see on the bottom side of that cartridge, there's a tremendous amount of intellectual property represented there with the placement of the reagents and the actual place where PCR takes place, and that's where the lyophilized balls go. You'll also see some other freeze-dried reagents in those cartridges. But no, we don't expect to have a redesign of the cartridge in order to conduct blood-based pathogens. We are excited about the possibility of being able to do maybe a direct injection. If you take the slide that showed you the little pipette, there is a possibility, it hasn't been proven out yet, but there's a possibility that we can take a direct sample from a finger prick.
As you heard me describe, it's treated as soon as it has contact with the blood to kill the virus, whether it's Ebola or something else, and then to directly inject that into the cup. But the most near-term possibility comes from going from the finger prick into the little collector and then into the separator. There's a little receptacle on the top of the GoCollect. The pipette fits in very nicely. You put it in, and five minutes later, you've got a separation of the plasma from the red blood cells, and then that plasma sample gets put directly into the cup. But as far as the cup is concerned, we expect that technology will remain as it is. It just opens us up to a whole new area of blood-borne pathogens such as HIV and hepatitis B, hepatitis C, and others over time.
I actually wanted to follow up on that last point that you were making. Do you have a sense of what proportion of the pathogen detection market is represented by blood-based pathogens versus something like a mucus or sputum-based?
We've spent a lot of time looking at the size of that total addressable market, and I can't give you an actual number standing here today. I have a lot of numbers that we've researched and that are swimming around in my head that get up as high as 100 million of these different combines. It's very easy for you to get a sense of that by doing a search of the top blood-borne pathogens, and you'll see all kinds of details about what percentage each of them, what percentage HIV is, for example. And it's a biggie. That's sort of at the top of the list. And hepatitis B, hepatitis C, they're all up there.
If you look at the company that I mentioned, and they're a wonderful company, the Molbio company, and they've got more history than we have, but when you see the kind of diseases that they're featuring in addition to tuberculosis, you'll see those same pathogens specifically mentioned, HIV, hepatitis B, hepatitis C. Our simple contention here is that in order to fill the gap in a place like India and other low and middle-income countries, you've got to have a device like our device that costs so little money to put it in a primary healthcare facility compared to what it takes to put in a Cepheid device or a Molbio device. We're just a small fraction of the cost of what those other companies have to bear to get an instrument placed.
We have high confidence in that there's a ready market ready to take and give us throughput in those 650,000 type of villages that don't have any access. They have no access whatsoever to molecular, and that's what's got to change. If you talk to all the key opinion leaders in tuberculosis throughout the world, Dr. Pai, for example, he will assert that the first thing that's got to happen is we've got to stop the smear microscopy and convert it to molecular testing. We intend to make that now possible. It just hasn't been possible in the past because the price of the instruments is too expensive. And even if it's available, if you can't afford it, you can't do it. And we're making it affordable. It's accessible, it's affordable, and it's PCR accuracy, the gold standard. Three As. Okay.
Thank you. And then one last one from me. I wanted to ask about the automation of your manufacturing process for the cartridges, how that impacts your cost of goods and throughput. And then also, is this something that would help with consistency if you were to set up domestic manufacturing in the other regions you're working in, like the Middle East or India?
I mentioned in my presentation the advantages in terms of the labor that is required to do the automated throughput. We are very excited and very proud of our automated system here. This is not just a hypothetical wish right now. We are producing cups. Altogether, we have made, if you look at these little cups, we have made approximately 600,000 of these as we have gone through clinical trials and all the things we have had to do to optimize and get things prepared.
So to be able to now have an automated piece that gives us twice the throughput with half as many employees and half the time is really exciting. You are talking about the ability to take one of those automated lines, and those lines are not very much different than from that wall to about here. That is about how big that automated line is, and not very much wider.
You mentioned a key component here, and that is the quality control. When you have eight people on a line, it is hard to train them all as to what has to happen, and you are dealing with molecular diagnostics, so it is like rocket science at a molecular level. This allows us to have the kind of quality control using AI and other technologies that are inherent in that line that make it so we do not have to cross our fingers when something comes off the line and it goes into packaging and gets out into the field because it has all been quality controlled several times through the process of manufacturing it. When we talk about that throughput, when we say it is 16, 17 seconds, that is how long between each cartridge that comes off the line through the day.
We showed you the number of 2,000, and that was just in one working shift. These things do not sleep. If you do two shifts, you have not 2,000, you have twice that. If you have three shifts, you have more yet again. So it is very exciting what this implies in being able to take an automated line to India, to CoMira in the KSA, in Europe, in Mexico, in the Far East.
It makes it so our ability to put a quality-controlled, reliable production capability is really simplified through this process. This did not happen overnight. This is not a project we have been working on for a few months. This has taken years and millions and millions of dollars. So it is a very serious project, and we are very happy that our team has gotten it into actual production. We are making cups now. Any other questions we can handle?
All right. Thank you, Dwight, and thank you everyone who joined us both in person and online. This concludes today's presentation.