NEW YORK – OraSure Technologies this week provided updates on its plan to submit a one-step rapid antigen test to detect SARS-CoV-2 to the US Food and Drug Administration for Emergency Use Authorization. The firm will file for prescription-use, self-test and professional use indications by the end of March, with an at-home self-test indication to follow.
With plans to expand its manufacturing capacities, OraSure said it will leverage its existing global relationships to supply the test worldwide for years to come.
On a call with investors on Monday to discuss the company's financial results, Stephen Tang, OraSure's president and CEO, noted that its $62 million of revenues notched in the fourth quarter were the highest in its history, and while the company's bottom line shrank in Q4 year over year – and OraSure saw a net loss for full-year 2020 compared to a profit in 2019 – some Wall Street observers were bullish about its future.
In a note to investors on Tuesday, Vijay Kumar of Evercore ISI said his team projects as much as $1 billion in 2021 revenues for OraSure, depending on the timing of the EUA and given the antigen test opportunity. That would compare to $171.7 million in revenues for 2020.
Tang said OraSure has completed development and clinical trials for its rapid SARS-CoV-2 viral antigen test and is on track to submit it to the FDA for EUA. Specifically, the firm has locked the proprietary assay chemistry and was able to accelerate clinical trials for the prescription self-test, he said, adding OraSure will submit both the prescription self-test and a professional use test by the end of the month.
Tang also announced that OraSure will expand its manufacturing capacity for antigen tests from a previously disclosed 50 million tests per year to 120 million. Last year, the firm received support to expand its manufacturing capacities from Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) as well as from the state of Pennsylvania.
OraSure is also continuing to supply 510(k) cleared oral fluid sample collection devices for molecular testing — a part of the business that netted the Bethlehem, Pennsylvania-based firm nearly $50 million in 2020.
And, it is resubmitting its lab-based oral fluid COVID-19 antibody test to the FDA for EUA. Specifically, it will submit an oral fluid sample collection pad intended for self-collection under the observation of a health care professional, separately from the OraSure SARS-CoV-2 ELISA microplate assay.
OraSure first declared its intentions to develop a rapid antigen test for SARS-CoV-2 early in the pandemic. At the time, the firm touted the fact that it was the only manufacturer of a rapid infectious disease test that had been authorized for home-use by the FDA. OraSure also emphasized that oral fluid samples would make its test easier to use than other options, and described a timeline culminating in a Fall 2020 launch.
In the interim, OraSure found that oral fluid samples were not as robust for the SARS-CoV-2 respiratory virus as initially anticipated, and it transitioned to nasal samples and revised its timeline for filing to Q1 of 2021.
In the meantime competition has quickly heated up in the new space of rapid instrument-free antigen tests for potential home-use. Firms with at-home, antigen test EUAs, or prescription-use EUAs with a home-use submission in the pipeline now include Ellume, Becton Dickinson, Quidel, and Abbott.
Yet, Tang cited a Rockefeller Foundation report that indicated 300 million tests per month are needed to safely keep schools open in the US, and projected a total market size for prescription self-tests on the order of about 16 billion per year. Furthermore, the demand globally will be higher and more sustained, Tang said, because vaccines are not likely to reach certain parts of the world for years to come.
"Multiple tests from multiple manufacturers will be required to meet the massive global need," Tang said, noting as well that OraSure's global footprint in HIV self-testing is "a real springboard" for the firm "to address the needs of the low and middle-income countries around the world."
The timeline for the OTC claim was vague, however.
"I think we want to see the performance of our prescription self-test product in the marketplace," Tang said on the call. He also noted that the biggest threshold for OTC is asymptomatic patients, a fact also cited by Quidel last month when that firm announced a delay in its filing for an OTC claim.
"We want to be careful to design the studies in a way that shows off the performance of the product, so we haven't announced anything in terms of timing for OTC but it still is clearly in our plans," Tang said.
For the antibody assay, Tang said that the firm's oral fluid test was shown in a recent study to have twenty-five times the throughput capacity of testing using blood-based sample collection, and that the test had a 91 positive percent agreement and 100 percent negative percent agreement with serology.
Lastly, on the M&A front, OraSure exited the year with no debt and $257 million to potentially spend on mergers and acquisitions. Tang described the firm's M&A pipeline as robust.
"It's a rich environment out there right now for targets," he said, adding, "We're intent on doing the right deal at the right time at the right valuation."