Good afternoon, everyone, and welcome to the OraSure Technologies 20 22nd Quarter Financial Results Conference Call and Simultaneous Webcast. As a reminder, today's conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer period.
Good afternoon. With us today are Doctor. Stephen Tang, President and Chief Executive Officer and Mr. Roberto Cuca, Chief Financial Officer. Steve will provide an overview of our quarterly highlights, including an update on our COVID programs.
Roberto will review the 2nd quarter financials, and Steve will then provide updates on our other business areas and strategy. We will then open up the call for questions. Before I turn the call over to Doctor. Tang, you should know that this call may contain certain forward looking statements, including statements with respect to revenues, expenses, profitability, earnings or loss per share and other financial performance, product development, performance, shipments and markets, business plans, regulatory filings and approvals, expectations and strategies. Actual results could be significantly different.
Factors that could affect results are discussed more fully in the company's SEC filings, including its registration statements, its annual report on Form 10 ks for the year ended December 31, 2019, its quarterly reports on Form 10 Q and its other SEC filings. Although forward looking statements help to provide complete information about future prospects, listeners should keep in mind that forward looking statements are based solely on information available to management as of today. The company undertakes no obligation to update any forward looking statements to reflect events or circumstances after this call. With that, I will turn the call over to our CEO, Doctor. Stephen Tang.
Thank you, Gene. On today's call, in addition to our customary overview of business operations and financial performance, I'm going to walk you through why we believe our antigen and antibody tests under development for COVID-nineteen are extremely well positioned to serve the needs of the testing market and to present an enormous revenue opportunity for OraSure. We think our biggest challenge after obtaining emergency use authorization from the FDA may very well be how to manufacture enough devices to keep pace with demand. We will also be reviewing our segments and highlighting how COVID-nineteen has helped or hindered various aspects of our business. The net takeaway on our financial performance for the remainder of the year is that we believe the back half of the year is looking very strong.
As a result, we expect the company to post year over year revenue growth and to further execute on our innovation growth strategy. For those of you not familiar with OraSure, we are experts in rapid point of care testing for infectious disease, sample collection and stabilization for molecular testing and laboratory and bioinformatics services for microbiome analysis. These capabilities position us well to respond to the global testing needs the COVID-nineteen pandemic has created. We have a long and proven track record of applying our scientific and technological expertise to developing innovative sample collection kits and accurate tests for infectious diseases. We've been able to respond quickly to the COVID-nineteen pandemic.
Working with regulators like the FDA and other stakeholders, while scaling up for global markets. We have existing broad, well established channels of distribution across global public health, laboratories, employers, hospitals, physician offices, pharmacies and direct to consumer. And as we discussed last quarter, some existing products are already addressing certain aspects of the COVID-nineteen testing market. We're leveraging expertise to address the COVID-nineteen pandemic in 3 specific ways. First, our sample collection devices are being used for the collection, both in home and professional settings and transported samples for COVID-nineteen molecular tests.
In addition, we're developing 2 COVID-nineteen tests that we believe could be key contributors to the existing testing paradigm. The Orquic coronavirus rapid antigen self test and the OraSure SARS CoV-two oral fluid antibody test. And additionally, we are applying our operational expertise and experience to substantially ramp up our manufacturing capacity to meet existing and anticipated demand on all three fronts. Roberto will be providing additional details on this later in the call. But first, I'd like to take a step back to review the current state of the pandemic and OraSure's place in the international response.
To date, there are more than 18,000,000 total confirmed COVID-nineteen cases in the world, with more than 4,000,000 cases in the United States alone, according to Johns Hopkins University. Sadly, numerous U. S. States are currently experiencing a summer surge of cases, hospitalizations and deaths. Central to the debate about how to best reduce the spread of the virus and alleviate the misery of millions of people is testing, which a recent Rockefeller Foundation report cites as, quote, the only way out of the present disaster, The foundation notes that widespread testing to detect asymptomatic individuals is crucial to containing the spread of the pandemic in workplaces, schools and communities, and specifically calls for point of care antigen tests to increase testing capacity, speed and convenience.
As a leading company with more than 20 years of proprietary knowledge in oral fluid testing, soft collection and rapid in home results and with our broad, well established global distribution channels, we are well positioned to become a substantial contributor to reducing the spread of COVID-nineteen. The timing, too, is fortuitous as we enter the fall season when students return to school, while we continue to try to reopen our economies and our communities face the compounding problems of seasonal flu, we expect to bring important new diagnostic tools to the market. Further, while we are hopeful for a vaccine very soon, it's important to understand that vaccines may not be 100% effective. Some people may decide not to get vaccinated and manufacturing distribution capacities may not provide worldwide coverage. For these reasons, we believe expanding testing options will be needed over the long term.
The antigen tests we're developing, the OraQuick Coronavirus Rapid Antigen Self Test, would quickly detect active COVID-nineteen infection at the point of sample collection with no instrumentation needed to interpret results and no need to transport samples to the lab for analysis. Pending regulatory approvals and launch, individuals would be able to obtain the test, take it on their own and read their own results a short time later. This could be invaluable to opening up economies, keeping them open and enabling the safe return to work, school and group events. We initially planned this test to receive an DOA for testing individuals who are either symptomatic or suspected of being infected and eventually for asymptomatic individuals. The test is built on the proven OraQuick lateral flow platform, which is a foundation for Orchard's current in home and professional rapid diagnostics for HIV, professional HCV tests and a 510 clear Ebola device.
Versions of our HIV test are already used by millions of people around the world each year. We are leveraging this expertise to bring the OraQuick coronavirus rapid antigen self test to market. When we started test development, we intended to use oral fluid as a sample type, as in our HIV test. However, as research and development progressed, we found we could achieve greater sensitivity and the best possible accuracy by using samples collected with a simple, fast swab just inside of the nostril. To be clear, this easily and comfortably self collected lower nostril sample is very different from the use of the long nasopharyngeal swabs you may have seen or even experienced yourself.
Our solution would be a quick, painless swab that laypeople and medical professionals alike can easily administer anytime, anywhere. To date, there are no tests for active COVID-nineteen infection that provide a result short after sample collection and require no instrumentation. The Rockefeller Foundation report on testing specifically calls for rapid convenient tests like the antigen test OraSure is developing to help get the 30,000,000 tests per week many believe are needed by November to reduce the spread of COVID-nineteen. This massive need is why we've been investing heavily in capacity expansion now in parallel with our clinical studies, so we can be in a strong position upon authorization. The antigen test is currently in human clinical testing, which will provide the necessary real use data to file for FDA Emergency Use Authorization or EUA and enable us to bring this test widely to the market targeting a Q4 launch.
As we announced in April, we have received just over $700,000 from BARDA to help bring this test to VUA. We are also developing an enzyme linked immunosorbent assay, ELISA, for the detection of human anti SARS CoV-two antibodies in oral fluid specimens. This test is based on our existing ELISA microplate platform, which uses oral fluid samples to test for drugs of abuse with a platform formulated to detect COVID-nineteen antibodies. To date, there are no oral fluid antibody tests commercially available with automated assays. With this test, human antibodies found in oral fluid would be collected easily and conveniently via a wand and pad and alluded into our existing oral fluid specimen collection device buffer for storage and transport and later dispensed into the ELISA microplate for laboratory testing.
Like our antigen tests, our antibody test development is backed by BARDA, from whom we received over $600,000 in funding in June. We now expect to file for EUA for the ELISA test in subsequent launch in the 4th quarter, a slight delay from our initial time line due to challenges in obtaining a sufficient number of positive clinical samples against which to run tests. We have since expanded the number of sites we use for clinical testing and are confident that this issue has been resolved. We recently completed the final product design and believe we will have an assay with expected high sensitivity that is currently in clinical testing. We are working to increase capacity ahead of FDA authorization and launch.
I'll turn last to our molecular collections capabilities in COVID-nineteen, which are already generating revenue. Our goal for this segment of our business is to broaden the reach of COVID-nineteen molecular testing by enabling noninvasive reliable sample collection that can be done in a variety of supervised and unsupervised settings. We do this by collaborating with our customers, including reference labs, large diagnostic platform companies, academic institutions and employer groups to validate our device with their assays. Our devices are currently being used in significant population screening programs by employer groups, government agencies and educational institutions. The device is used for polymerase chain reaction or PCR testing, which detects genetic material of the COVID-nineteen virus.
To date, 3 devices from our DNA GeneDetect subsidiary, including the Orcollect RNA collection kit, Omnigene oral saliva collection device and OraGENE DX device have been included in EUAs granted to 4 customers: Clinical Reference Laboratory, or CRL BioSerna, T23 Labs and Phosphorus. Permitting these devices to be used for supervised and unsupervised COVID-nineteen sample collection. Meet the regulatory requirements for inclusion in these EUAs, we have successfully demonstrated viral inactivation by our stabilization chemistry and consumer ease of use. To further increase the reach of molecular testing, we are also generating data to support additional global regulatory clearances for our products. We expect more customer EUAs incorporating our products to follow.
We generated $8,500,000 in revenue from COVID-nineteen use in our existing molecular collection products in the Q2 and expect continued strong contribution. We are excited about these three opportunities to address COVID-nineteen and expect to continue to see significant revenue from both the Molecular Solutions and Infectious Disease business units. Importantly, we expect that gains from these existing new COVID-nineteen products will offset any impact on our core business from declines in both genomic research and the HIV and HCV testing markets resulting from COVID-nineteen. We are continuing to grow by investing in COVID-nineteen and are putting ourselves in position to come out of the pandemic stronger with opportunities across business areas. I will now turn the call over to Roberto for detail on our quarterly financials and our efforts to expand our manufacturing capacity.
Thanks, Steve. Net product and service revenues for the 3 months ended June 30, 2020 decreased 24% from the comparable period of 2019, primarily as a result of lower sales of our genomics products due to the timing of orders placed by one of our largest genomics customers and due to the impact of the COVID-nineteen pandemic, lower sales of our domestic HIV, HCV, risk assessment and microbiome products due to reduced research and testing as a result of the COVID-nineteen pandemic and the absence of cryosurgical sales, all partially offset by the inclusion of product revenues associated with COVID-nineteen testing and higher laboratory services revenues. International sales of the company's OraQuick HIV products decreased 28% compared to the Q2 of 2019. This decrease was due to delays of shipments, which moved from the end of the second quarter into the early third quarter. Importantly, even including the effect of the shipment timing on the quarter, the underlying international HIV Self Test business is still showing strong double digit growth on a year to date basis.
Total product and service revenues for our DNA Genentech business unit were $18,100,000 during the Q2 of 2020, an increase of 4% in the Q2 of 2019. This included $8,500,000 in sales of oral fluid collection devices for COVID-nineteen molecular testing. Total laboratory service revenue in the Q2 of 2020 was $2,200,000 compared to $1,200,000 in the Q2 of 2019. Laboratory services in 2020 included the revenues generated by both of the company's laboratory services subsidiaries, which are now operating under the Diversion brand. As we disclosed in our press release, we will not be providing financial guidance for the full year at this time.
This is because of the unpredictability of both the negative and positive impacts of the COVID-nineteen pandemic on our operations. However, we do want to share the following color on our expectations for the business. With respect to the full year, we expect that excluding cryosurgical revenues from 2019, non COVID-nineteen revenues in both the infectious disease and molecular collections lines of business will be down in 2020 compared to the year ago period with molecular impact. However, we anticipate that revenue opportunities for our COVID-nineteen sample collection products and tests will more than offset this year on year decrease in our non COVID-nineteen lines of business, such that total revenues will be higher in 2020 versus 2019. The majority of this contribution will come from our Molecular Solutions business unit, which as I just mentioned, has already achieved $8,500,000 in COVID-nineteen related revenues in the Q2 of this year.
Within 2020, we expect that the just completed Q2 will be the lowest revenue quarter. We expect that non COVID-nineteen revenues will be flat or improved for each business unit in the 3rd and 4th quarters compared to the Q2 and COVID-nineteen product sales will add to this performance. Of note, at the time of our Q1 earnings call on May 6, we announced that we had line of sight via purchase orders to $3,600,000 in Molecular Collections COVID-nineteen revenues and we ended the quarter with $8,500,000 of these sales. This suggests that sales were ramping within the 2nd quarter and in fact we expect that revenues for these products will be materially greater in the 3rd 4th quarters. With that, let me turn to manufacturing capacity where as we've disclosed previously, we're making investments to significantly expand the number of test collection devices we'll be able to provide to help combat the pandemic.
First, we're currently able to manufacture the 3 product lines being used for COVID-nineteen molecular sample collection at the rate of approximately 35,000,000 units a year. Of these, 7,000,000 to 8,000,000 units are expected to be used for non COVID-nineteen applications. The capital expenditures that are underway in the Molecular Solutions business unit should expand this capacity to a rate of approximately 75,000,000 units annually in the Q2 of year and further to 80,000,000 units annually in the Q3. Next, I'll talk about our in development antigen test based on our OraQuick rapid test platform. Today at our sites in Bethlehem and Thailand, we are able to manufacture approximately 35,000,000 OraQuick tests a year, of which around half are expected to go to HIV, HCV and Ebola testing.
We have initiated the installation of new lines at both sites that will expand Finally, for our antibody test, our Finally, for our antibody test, our current capacity is approximately 10,000,000 units a year, of which about 3,000,000 units are devoted to existing products. We plan to double this capacity by installing lines at our 3rd party site. This work requires a longer lead time and we expect it will be completed by the Q4 of 2021. To support these capacity expansion activities, we are planning to hire over 150 additional full time employees to manufacture the additional volume of products. We are also continuing to investigate the possibility of partnering with or sub licensing to 3rd parties to further expand our ability to meet anticipated demands in all areas, which will be additive to capacity that I just outlined.
Summing up, we ended the 2nd quarter in a strong financial position with no debt and $265,800,000 in cash, including $95,000,000 in net proceeds from an equity offering in June and are well capitalized to support future growth. With that, I'll turn the call back over to Steve.
Thank you, Roberto. As Roberto mentioned, we're seeing both headwinds and tailwinds in our core businesses due to the COVID-nineteen pandemic, but continue to execute across our diagnostics sample collection and service business lines. Taking a deeper dive into our HIV business. The pandemic has had a negative impact on HIV testing nationwide as in person testing programs have been forced to pause or shut down in an effort to comply with social distancing requirements. Overall, professional HIV testing in the U.
S. Declined 50% to 70% since the pandemic began, according to the Centers For Disease Control and Prevention. However, our over the counter HIV in home test has been able to offset declines in the professional testing to some extent as public health agencies are providing our in home self test to their clients. Consequently, our sales decline of 28% was far less than the 50% to 70% estimate by the CDC. During the past few months, several government agencies have recommended that organizations establish HIV self testing programs to immediately address the challenges posed by COVID-nineteen and in person HIV testing.
These agencies, which include the CDC and the Department of Health and Human Services, have also guided federally supported organizations to use grant money for HIV Self Desk Kits. OraSure is working in collaboration with government agencies and public health organizations to ensure that those who need HIV tests are able to get them. The federal government's initiative ending the HIV Epidemic: A Plan for America has set a bold goal of ending the HIV epidemic in the United States by 2,030. We've been encouraged to see proposals to significantly increase federal funding for this initiative in fiscal year 2021. Accessing the difficult to reach populations will be key to achieving this goal, and rapid testing that can be brought into communities is seen as an important tool.
With the only FDA approved in home self test in the market, OraSure is well positioned to play a key role in the plan for America and capitalize on the market opportunity it represents. Launching innovative efforts like rapid HIV self testing programs will be critical in our continuing fight to end HIV epidemic, particularly in the face of COVID-nineteen. Augmenting our efforts in the HIV market is our recent acquisition of YourSure Inc, a company developing and commercializing products that measure adherence to medications that prevent and treat HIV. This cash transaction closed in July and supports our strategy of expanding our core offerings to include additional diagnostic products, particularly point of care tests that complement our current infectious disease portfolio and pipeline. We will be able to offer a full HIV portfolio that covers the spectrum from screening to treatment adherence, 2 pillars of the Plan for America initiative.
Beyond HIV, we have the 1st and only FDA approved CLIA waived rapid HCV test. Our revenue in this area was affected significantly in the 2nd quarter as a result of COVID-nineteen, but we anticipate an eventual return to more normal levels of revenue after the pandemic begins to resolve and test sites are reopened. Similarly, we see long term opportunities in our substance abuse testing business in future periods as federal guidelines now prevent oral fluid drug testing. Moving on to our sample collection products and laboratory services businesses outside of COVID-nineteen. We are seeing a continual increase in demand for saliva collection devices among customers who historically use a mix of blood and saliva samples as in clinic sample collection of blood remains difficult.
We continue to launch new collection devices, expanding our range of sample types and analytes to meet the needs of research and academic institutions. For example, our OmniMet gut collection kit for metabolomics launched in June is the 1st and only commercially available research use only device for in home self collection of fecal samples for metabolomics. Despite year over year growth, our service business remains challenged by the shutdown of University Labs and by other sample access delays due to COVID-nineteen. However, there are some encouraging developments that will set the stage for future opportunities. We continue to build on relationships and execute clinical studies with pharmaceutical and biotechnology companies.
Additionally, we have several small ongoing pilot studies in the direct to consumer wellness area and believe this will be a growth opportunity. From an industry perspective, several microbiome therapeutic companies, including ReBiotix and Vendanta, have reported positive results from their clinical trials, and Seres Therapeutics is expected to report in late Q3 2020. These are all considered bellwethers for the industry as positive results will continue to drive investment in microbiome research. Given our industry leading capabilities, we are well positioned here. I'd also like to give a brief update on our Novosanis subsidiary.
We continue to see advancements in the validation of first void urine as a valuable tool in detection of various cancers and recently achieved CE IVD marking for our new small volume colo P devices compatible with several large automated diagnostic platforms. Complementing our internal growth is a strong business development strategy. We are aiming for significant increases in revenue through organic and acquisitions. We are using our robust balance sheet to create revenue and shareholder value. COVID-nineteen has certainly complicated the business development picture, but it's also opened up new opportunities in technology in infectious disease for us to explore and pursue.
So let me assure you that we are not sitting on the sidelines. We continue to engage in the pursuit of business development opportunities that are accretive to our innovation growth strategy, and we remain committed to doing the right deal for the right price at the right time for our company and our shareholders. In closing, we are honored to be part of the fight against COVID-nineteen and apply our expertise to filling unmet need in the testing paradigm, while continuing to execute across our core business. Given our ongoing initiative to scale up our production capacity, we are confident that we will be able to deliver substantial increased volumes of COVID-nineteen collection and testing products, while ensuring they meet the highest quality standards as we contribute to the fight against this global crisis. We wish everyone and their families good health and look forward to providing future updates.
And with that, I will open the call up for your questions.
Thank you. Our first question comes from Frank Taconan with Lake Street Capital. You may proceed with your question.
Hey guys, thanks for taking my questions and congrats on all
the solid progress this quarter so far. Thank you, Frank.
Thanks, Frank. A couple of questions from me today. Starting with the antigen test, just curious if you could take a little deeper dive on why you decided to switch that to nostril collection from the original oral swab collection? And then as a follow-up to that, assuming development stays on track from here on out, can you give us a little background on different milestones you're looking for between now and the Q4 launch, whether that's EUA submission, if that will be announced? And then how long you take how long you expect EUA to take given the high influx of EUA submissions?
Sure. Let me start to answer Frank and if I missed any portion of your question, please re ask it. First of all, we had originally set out to have an oral fluid test, as you noted, and then we simply follow the science. And what the science led us to is the fact that nasal swabs, which are still pain free, still convenient and still able to be self administered, had a higher viral load and led to better accuracy for our tests. And so we've taken that into clinical trials where it is today.
And so we simply follow the science to get the most accurate analyte type along with abiding by our principles of easy to use and convenient and pain free. So that is that's why we settled on the nasal swab. We are currently in clinical trials, as I mentioned. I think the next milestone for us internally is prototype block, which I think we are just a few weeks away from at this point. And then we have accounted for the cycle for approval for FDA to EUA and that's why we've settled on our 4th quarter launch.
There is still some latitude provided that FDA's timing still holds. So I think we are extremely confident that we've got an excellent product in the process. Having done this before with our HIV product, moving it from a professional product to an in home product to a self test and moving along the BARDA funded Ebola rapid antigen test. I think we've been able to leverage all that expertise into this antigen test. So I think we're very confident, which is why we've also announced the increases in capacity for our various products, including the Amigen product to allow us to build product at risk to have a supply on hand when we actually launch in the Q4.
So if I didn't get all your questions or all the aspects of the questions, please re ask them, Frank.
No, that's great. I just think one more question on the antigen test, I guess a 2 parter on the antigen test. Could you talk about some of the different end markets you are in communications with? And if there's been any contract sizing been discussed, if it's whether it's back to work or back to school. I saw with some of your different EUAs you got on collection side, but some of the end markets.
And then could you also touch on how you were thinking about pricing?
Certainly. So we have not disclosed pricing as yet, but we believe it will be in line with pricing of our current portfolio of products and competitive in the marketplace. As far as use cases and applications, it's those discussions that have effectively informed our production capacity increases and really for all the products, not only the antigen test, but our self collection for saliva, oral fluids, nasal swabs as well as the antibody test. And so that's why you're seeing such a concerted effort for us to move those that capacity enhancement forward and to share it with you today. As far as the use cases, I think it's pretty clear that this will be a first of a kind product, the rapid antigen test.
It really solves 2 key dimensions. It's convenient and it's accurate, and it enables self collection and immediate results. So the combination of those factors lead us to exactly what you said, back to work, back to school applications. So we've received inbound interest from large employers, from schools, both K-twelve and universities, government agencies. There's a wide distribution of potential large buyers.
And so that's why we've ramped up. And I think it's everything you would expect that solves the current testing dilemma, which is the timing between when you get actually sampled and when you get the test result back. So we'll be refining that and dealing with the inbound demand in the coming months. Great. And if I
could just move to the collection side of the business. Could you talk a little bit about the size of the different testing capacity of the different companies that you have gotten EUAs with BioSterna, P23, Phosphorus and CRL. Just kind of curious on which one of those are driving a lot of that COVID related collection revenue? And if it's CRL, how do you expect that to inflect the revenues, going forward?
Sure. So CRL is by far the biggest one of our customers that's announced in the UA. They're one of the biggest private reference labs in the country. And so, I think that bodes well for how we are looking at revenue for the rest of the year for our molecular sample collection kits. So, I can't really speak in detail about how the size of the EUA's by size of the labs that have received the EUA's plays in.
But I can share with you that there are several more EUAs in process as well as strong working relationships with labs that are using our set collection device that may or may not need an EUA. So that's a bottoms up revenue build that has caused us to look for additional capacity overall and project those revenues favorably for the rest of the year.
Perfect. And then if I could just squeeze one more in here and I appreciate all the time.
Actually, if you could reenter the queue so we can get some other questions from other analysts, that would be great. Thanks, Alex. Thank
you. Our next question comes from Jacob Johnson with Stephens. You may proceed with your question.
Hey, thanks. Maybe just a quick follow-up on that last answer from a housekeeping perspective. Did you recognize any revenues from CRL in 2Q or is that kind of a 3Q opportunity?
Go ahead, Roberto, please.
So thanks for the question, Jacob. So typically, we don't identify which customers have been contributing to our revenues. As Steve mentioned, one of the important points there is that we are actually selling a lot of product to customers that haven't announced EU waves, but we do have a broad footprint of customers, which gives us a lot of optimism for the second half of the year.
Okay. That's helpful. Thanks, Roberto. And then last week, I think the FDA released some guidance for non laboratory COVID testing that's requiring 90% sensitivity and 99 and that's requiring 90% sensitivity and 99% specificity. How does that impact your rapid test or does it not really impact what you're trying to do?
So Jacob, are you referring to the template for over the counter products?
I believe so, yes. There was something the FDA released last week
on that. Yes. So we've obviously digested that because that's sort of key to our overall product strategy for the rapid antigen test. We don't see anything in those guidelines that surprises and they're all issues that we've tackled before with other products, in particular, our HIV at home test. So I think we're it's squarely in our strike zone.
Got it. I'll leave it there. Thanks for taking the questions.
Thanks Jacob.
Thanks Jacob.
Thank you. Our next question comes from Andrew Cooper with Raymond James. You may proceed with your question.
Thanks, guys. Maybe first, just as we think about you mentioned back to school, back to work. As we think about what that looks like in terms of a 4Q launch, obviously, schools will have largely gone back. How do we think about, I guess, one, where in 4Q timing might be, if you have any more detail you could give on that? And 2, how you think about addressing that end market given the timing being a little bit after when most of schools are, at least as of now, hoping to return students to campus?
Yes. It's an interesting question because usually we would see students back in school right after Labor Day, right, if not earlier in some parts of the country. The key here is not only back to school, but staying back in school. And that the presumption there is that there won't be any infections that effectively shut down the schools that will cause them to move to another plan to reopen using better ways of ascertaining who is infected and who is not. In some parts of the country, notably in Philadelphia, the school district will go virtual until November and then make a decision whether to come back.
So I don't believe we're missing significant opportunity because I don't think there are any better solutions out there to mass test students, K-twelve students as well as higher ed students, undergraduate and graduate students to bring them back safely to campus and keep them safe on campus. And so, our launch in the Q4 and of course, Q4 begins in October when we're trying to make it get full exposure to the quarter as much as possible, I think gives us a sweet spot in the marketplace. So this will be a first of the kind product, an instrument free rapid test. And so I think there is plenty of room in the marketplace to have some very exciting opportunities of size for us.
Okay, great. That's really helpful. And I guess maybe one on the collection side asking a little bit different way. Last quarter, you talked about the 3,600,000 line of sight turning into 8.5 or so. Can you give us the number for sort of what you feel like you have good line of sight to in this quarter, even if it's just with the EUAs or kind of all customers combined?
Is there any sort of number you could give us to give us a little bit better sense of how things are tracking from that perspective?
So we haven't provided specific business unit line guidance. What I'll tell you is we expect it to be substantially greater than the $8,500,000 that we achieved in the second quarter. But a lot of what the actual number becomes will depend on the timing of our manufacturing and of orders coming in. So for the same reasons that we're not providing full year guidance, there's some unpredictability around this. So we can't give you a specific number.
Sure. And maybe just one more. But as we think about the template that was referenced and sort of the decisions of where this product is being sold, Is there anything you can share in terms of how you think about the launch and pushing this into market, especially as capacity ramps? Is it more of a clinical setting to start or more of a professional setting, I should say, and we should think about ASPs at sort of that level before you really ramp and then have the capacity to sell more to the broad consumer? Or is there a different way to be thinking about this?
So let me take it from the perspective of how we'll sequence the EUAs, okay? So we're going to follow the FDA requirement for the initial EUA, which is to typically start with authorization for prescription use, then followed by over the counter authorization. So given latest discussions with FDA and the latest home use template, we're going to have a phased approach. So our initial launch will be into the professional market for testing symptomatic individuals or individuals that have come in contact with people infected with COVID-nineteen or suspected of COVID-nineteen infection. The second phase will be a prescription use self test with the same intended use population as the professional product I just mentioned.
Then the 3rd phase will be an over the counter product. We'll be looking to obtain a claim for asymptomatic individuals. So the goal for the EUA is for the first two phases, so that's the professional use and then the prescription use self test to happen in the Q4 and the OTC claim to happen soon thereafter. So once we're authorized to sell the rapid tests to health care professionals, public health institutions will follow as well as employers, schools and then consumers. And so you can see that phased approach opens up the market for a lot of different segments market segments and we'll address the pricing and volume issues from there.
Okay, great. And maybe just one more on that. When we think about obviously, we've seen the template, but when we think about sort of that process of getting that last phase over the counter, EUA, is it is the main sort of thing that you feel like the FDA is going to look for that somebody the average Joe can do this without a mistake and can get a correct answer and then know what to do with that answer? Or what are kind of the steps that you need to do to be able to show that to give the FDA comfort? If you have a sense for that, that would be great.
Sure. It's very similar, Andrew, to the process we went to in 2012 to get our then HIV product from professional use to over the counter use. So I think we're one of the few companies that have actually done that for a diagnostic product for infectious disease. So I think that we understand those challenges and we understand basically what the FDA is looking for. So I think that's why we're very confident.
Okay. I'll stop there. Thanks for the time.
Thank you.
Thanks, Andrew.
Thank you. Our next question comes from Brandon Couillard with Jefferies. You may proceed with your question.
Good afternoon. Maybe one for you, Roberto. You pointed to expectations for positive revenue growth in the back half of the year. Can you just sort of speak to the level of visibility there? Was that a true statement for both the 3rd and the 4th quarter?
And could you quantify the magnitude of the HIV Self Test order fout that moved into the 3rd quarter?
Sure. So, what we said is that, so we expect the 2nd quarter to be the lowest revenue quarter of the year and we expect the 3rd and 4th quarters to be either flat or up for each of the two business units. And then and that's in the non COVID-nineteen business. Then layered on top of that, obviously, we have the collections business, which we've achieved the $8,500,000 of revenues in the 2nd quarter and the antigen and antibody tests businesses, which we expect to be launching in the Q4, which is what contributes to our expected growth for the year. With respect to the HIV shipment, one of the I think one of the dynamics that's going on is that our HIV order lead time, our international order lead time is longer than for our domestic orders.
So what you saw is that in the Q1, there was very little disruption to our HIV international business. So what I'd say is that, the size of that order that shipped from the second to the third quarter would have gotten us very close to flat versus 2019 into the Q2. And then you did see we did see some disruption from COVID-nineteen, which capped the brakes on growth for the 2nd quarter, but we expect some of that to be turning around into the 3rd and 4th quarters.
Okay. Then my second question is really just broadly around the utility of oral fluid for COVID-nineteen testing. 2 of your existing DNAG customers who probably know more about oral fluid than anyone Helix and Collagenomics have both rolled out their own COVID testing services that don't use oil fluid collection devices. Can you just sort of speak to the level of visibility or sustainability of those customers that are using those collection devices. And the utility of that is a best case collection sample?
Yes. So in the case of the customers that you mentioned for our molecular sample kits, just keep in mind that the challenge of stabilizing DNA for genomic analysis is quite a different challenge than stabilizing RNA for infectious disease analysis. So I don't think there's any read through on the fact that we have been successful with our customers with saliva for molecular analysis. And so there's no real way to translate that. Having said that, we believe that oral fluid is an effective appropriate sample type for many types of COVID related diagnostics and screening tests.
And we've noted that we've locked in a prototype for antibody test that shows strong performance for oral fluids there. We've also repeatedly seen that technically saliva collected with devices from DNA Genotec is an excellent sample type for collection, transport, detection for the SARS CoV-two analysis, and that's supported by those multiple EUAs from independent laboratories. The vast majority of publications support saliva as a good sample type alternative to nasopharyngeal swabs and support the use of saliva for self collection, which has the opportunity to significantly increase testing opportunities. So obviously, we are very bullish in this area, which is why we're investing CapEx to increase manufacturing to the numbers that Roberto shared earlier.
Thanks, Brandon. Thank you.
Thanks, Brandon.
And I'm not showing any further questions at this time. I would now like to turn the call back over to Steve Tang for any further remarks.
We'd like to thank you for your participation on today's call and for your continued interest in OraSure. Have a great afternoon and evening, and please stay safe and be well.
Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for participating. You may now disconnect.