NEW YORK – Since the beginning of the COVID-19 pandemic, OraSure Technologies has had its components used in diagnostic tests for the virus but has yet to make its own tests available.
That will likely change in the next couple of months, as OraSure has submitted its oral fluid antibody test to the US Food and Drug Administration for Emergency Use Authorization and is working on its SARS-CoV-2 antigen test for submission in the first quarter of 2021. The firm originally said the antigen test would be submitted to the FDA this year but has had to push back its development timeline due largely to changes in the test design.
The company is currently developing the antigen test for three different EUA submissions, which each have different sensitivity and specificity requirements – for professional use, 80 percent sensitivity is required; for prescription use, 80 percent sensitivity and 99 percent specificity is required; and for the over-the-counter self-test, 90 percent sensitivity and 99 percent specificity is required.
OraSure CEO Stephen Tang said, "We're hoping we have high enough performance to be able to meet the threshold for all three tests," but he noted that the "ultimate intent is to design a product to be a self-test from the outset" regardless of which EUA is filed for and obtained.
"Our goal is to get as close to the over-the-counter test performance criteria in our initial submission," Tang said. "We're essentially designing for the hardest criteria, the most difficult criteria, from the beginning." He declined to share the current data OraSure has for its test, but said the company had an independent third-party perform a limit of detection study with results finding it was "competitive with current rapid antigen tests on the marketplace."
The one-step test works the same way as OraSure's OraQuick tests for HIV, although it uses a lower nasal sample instead of an oral fluid sample. The sample is self-collected and placed in a developing solution, returning results with no instrument and read similarly to a pregnancy test, with a control line and test line. Customers will be able to use the test at any time, in any location – including at home. At-home testing for SARS-CoV-2 has been something of a reach for the diagnostics industry, with many companies claiming to be developing tests but little to show for it. The FDA granted the first EUA for an at-home test this week to Lucira Health for its loop-mediated isothermal amplification test.
Tests for professional use have an easier time getting to the market, Tang said, partially due to the lower sensitivity requirements. However, OraSure wants to be prepared to scale the test quickly for OTC use, which is why it's taking its time developing the test to work for all three uses. "From a company perspective, what it causes us to do is to frontload a lot of the work, the hard work to get it right as quickly as possible," Tang said.
The company decided to develop the three submissions in tandem because it believes the most useful COVID-19 product on the market would be a self-test, Tang added. He also noted that it doesn't matter who is doing the test specifically – the process is the same, regardless of whether it's professional, prescription, or OTC.
In professional use cases, the test would be used at drive-through sites, physicians' offices, and other locations with a healthcare provider present. Patients would swab themselves with the provider interpreting the results, Tang said on the company's third quarter earnings call earlier this month. Prescription use would have a patient swabbing themselves with a swab prescribed by a provider and would read the results themselves. Tang said on the call this would likely work well for universities and employers whose users could get a prescription via telemedicine.
For the self-test, patients could buy the test online or at drugstores, conduct it themselves, and interpret their own results, he added.
The SARS-CoV-2 antigen test, which has been in development since March, was originally designed to be used with oral fluid like its other OraQuick products, but the lower nostril sample was "the more optimal place to sample from," and OraSure made the decision to switch sample types in August, Tang said. In developing the test, OraSure sampled the tongue, the cheek, the back of the throat, and the nostril, he added. During the development, the company looked "for where is the virus most accessible and where are the results most repeatable."
The self-test goal means the test has to be usable by people of every skill level, and the company is drawing on its OraQuick HIV experience to optimize the test's usability, Tang said. The HIV test is used in low- and middle-income countries, where literacy may be low and professional laboratory scientists aren't available. The product has to be "usable repeatedly and without failure," he said. The company is conducting usability studies and has prototypes under evaluation at clinical testing sites, conducting trials for all three uses of the test in parallel.
Tang emphasized that the firm's experience with OraQuick HIV is a key benefit. The HIV test received 510(k) clearance from the FDA, meaning it had to reach a higher scientific bar than EUA. Currently, the OraQuick test is the only OTC self-test for infectious disease available in the US, Tang said. OraSure also quickly developed its Ebola antigen test and is drawing on that experience, although scientists knew significantly more about Ebola than SARS-CoV-2 when that test was being developed.
Although much of the focus has been on the US, since it has a significant portion of total cases, Tang noted that the US only has 6 percent of the population, and OraSure wants its test to be used globally. "It became very clear to us that the best way to help eradicate the disease around the world was to create a self-test for COVID-19," Tang said. "The opportunity for us to have a profound impact on global public health starts in the US, but it doesn't end in the US."
The company is aiming to obtain prequalification from the World Health Organization, as well as CE-IVD marking, as soon as possible, he added.
Tang said that testing will be needed for a long time to come – even once a vaccine is developed, it will take time to get to enough people to be effective. Eventually, he said, SARS-CoV-2 will be more like the seasonal flu, but there will still be a profound need for testing, specifically rapid and self-testing.
Although OraSure isn't currently working on a multiplex version of the test, Tang said it was in the realm of possibility. Multiplex tests for SARS-CoV-2 and influenza A/B, as well as respiratory syncytial virus, are becoming more common as the Western Hemisphere's flu season continues and diagnostic firms look to provide one-sample-fits-all tests.
Reimbursement for its test is still a question for OraSure, as there are CPT codes for SARS-CoV-2 antigen testing but the US Centers for Medicare and Medicaid Services would need a special category to address coverage for the one-step test, Tang said. That coverage also depends on the Biden administration's priorities for reimbursement and COVID-19 testing as President Trump leaves the White House in January, he said.
OraSure hasn't disclosed the cost of the antigen test, but CFO Roberto Cuca said on the earnings call the price for the test will be in line with pricing for other products on the same platform.
Manufacturing capacity for its tests is another concern, but OraSure is currently building new manufacturing lines and will go from a capacity of 35 million tests per year to 70 million tests per year by the third quarter of 2021, Tang said. "As soon as we lock the prototype for the rapid antigen test, we will begin to build inventory at risk," he added.
If and when the test receives EUA, Tang said OraSure will be ready to launch it without delay. "We're doing everything we can to make the product as widely available to as many people as possible from the outset and then into the foreseeable future."