The Evolving COVID-19 Market: FDA Clears the Way for Asymptomatic Screening Products

A year after it came into being, the market for coronavirus diagnostics is dramatically evolving with the focus of growth inevitably shifting to products designed for serial screening of the asymptomatic at home and at the point of care. On March 16, the FDA took measures to accelerate this change in direction by issuing guidance to help developers of asymptomatic screening tests bring their products to market quickly and more easily. Here’s a rundown of the new guidance “Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing” and what it portends for the future of COVID-19 diagnostics.

COVID-19 Testing 2.0

Notwithstanding the slight uptick of early March, COVID-19 case, hospitalization and death rates across the U.S. are falling and, knock on wood, will keep on declining in the coming months. Even so, COVID-19 isn’t likely to disappear, and as long as the virus remains a menace, people will need to get tested for SARS-CoV-2. However, test demand and utilization patterns will change. As cases fall, the emphasis will shift from testing the symptomatic for purposes of diagnosis and treatment to widespread screening of people in congregate settings regardless of whether they have symptoms.

Products meeting the new demands will have to get past the FDA goalie to reach the market. And therein lies the problem. Until now, all of the FDA’s templates to help developers secure Emergency Use Authorization (EUA) for COVID-19 tests have been for testing patients with COVID-19 symptoms, recent exposure or other risk factors. Although the agency had signaled its willingness to consider tests performed on a serial basis on the asymptomatic as part of a screening program, it hadn’t created any kind of template for those tests. And without guidance, many developers have been understandably reluctant to invest in serial tests. The new guidance may allay these fears and drive development of serial tests for use in screening.

The New Guidance

The new guidance isn’t just advice. It opens a streamlined and expedited path for EUA of serial tests, specifically point of care (POC) and at-home tests with demonstrated strong performance in symptomatic persons. For the first time, the FDA has indicated that it will grant EUA for such tests for over-the-counter (OTC) use without first requiring them to be validated in asymptomatic individuals. In a statement, the FDA expressed its belief “that evidence of a test’s strong performance in symptomatic patients combined with serial testing can mitigate the risk of false results when testing asymptomatic individuals.”

The guidance explains what developers must do to demonstrate the effectiveness of a test’s performance in symptomatic individuals to qualify for expedited EUA. Specifically, developers may generate validation data by testing symptomatic individuals serially according to the guidelines. According to the guidance, the FDA will consider authorizing serial tests for OTC use at-home and POC tests if they have a positive percent agreement of 80 percent or greater (compared to PCR) with 70 percent at the lower bound of the two-sided 95 percent confidence interval.

Serial tests with sensitivity in symptomatic individuals below 80 percent could still receive EUA; but the agency says that “clinical evaluation in an asymptomatic population would generally be expected prior to authorization of a screening claim, including for OTC use” for tests below the 80 percent mark.

Tests authorized for screening based on symptomatic data will also have to be validated in asymptomatic individuals within a certain timeframe. The FDA also says that it may revise or revoke the EUA of tests that aren’t validated and that don’t show adequate performance in asymptomatic individuals.

Takeaway

Companies in a strong position to benefit from this new regime include Quidel, which is currently developing an OTC version of its QuickVue SARS test, as well as those who have products already cleared for at-home use (see the box below). To date, only three companies have gotten EUA for OTC COVID-19 diagnostic products:

• Ellume for its all-in-one Ellume COVID-19 Home Test; and
• Cue Health for its Cue COVID-19 Test; and
• LabCorp for the Pixel by LabCorp COVID-19 Test Home Collection Kit.

COVID-19 Products with EUA Clearance for At-Home Testing

• TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific)
• BinaxNow COVID-19 Ag Card (Abbott Laboratories)
• EmpowerDX At-Home COVID-19 PCR Test Kit (Clinical Enterprise, Inc.)