The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”

The FDA announced at the beginning of May that it would no longer allow non-lab serology tests to go to market without undergoing the EUA process, a move prompted in part by unsupported claims by developers. The agency’s May 21 statement noted that some of the removed tests were withdrawn voluntarily by the sponsor. Other tests fell off the notification list because the sponsor either failed to post a request for inclusion in the EUA program or did not receive an affirmative response from the FDA.

In addition, the agency said the 10-day notification policy for serology tests was effective as of the date of the May 4 policy change or the date the sponsor notified the FDA of its validation data, whichever was later. Hahn said the agency has seen “a high level of collaboration and engagement from developers who want to get this right,” vowing that the FDA will stay engaged with developers to bring accurate tests to market.

Also, the agency is maintaining a list of serology tests for which performance data has been made public. The listing includes the name and sponsor, as well as the rates of sensitivity, specificity and positive and negative predictive values for the antibody isotypes covered by the test. Among these is the Microsphere immunoassay from the Wadsworth Center, which is operated by the New York State Department of Health, and an ELISA test from Mt. Sinai Hospital’s clinical lab. These are the only two nonprivate sector tests among the 13 that are listed. With that said, the FDA has indicated that it will list state-authorized tests if the lab presents its validation data for EUA listing.

Outlook for tests up thanks to Medicare rates

Makers of the EUA tests face the traditional twin gauntlets of FDA review and Medicare coverage and rate-setting, and a recent update to rates posted by the U.S. Centers for Medicare and Medicaid Services (CMS) appears to have had the intended effect. A May 20 investor bulletin from William Blair & Co., LLC, of Chicago, said the new Medicare rates had exceeded the consultancy’s expectations, and thus several companies now are expected to outperform previous prognostications.

The agency posted the new rates for a variety of CDC and non-CDC tests May 19, and the American Clinical Laboratory Association signaled its approval, albeit with the implicit criticism that rates previously had served as an impediment to testing. The CMS said in a March 5 statement that the publication of two HCPCS codes for CDC and non-CDC testing labs would “encourage testing and improve tracking,” although the rate update suggests the agency heard plenty from stakeholders about the previous rates.

The Blair report noted that the firm’s analysts had projected rates of about $25 for serology tests, a considerable underestimate vs. the $42.13 Medicare now will pay. Serology testing volume for Quest Diagnostics Inc., of Secaucus, N.J., had reached 975,000 by May 19, up substantially from 375,000 registered only 16 days earlier. Quest’s diagnostic testing volume via molecular/PCR tests has exceeded 2 million, and the Blair report said Quest is in a position to produce 200,000 serological and 70,000 molecular tests daily. As a consequence of the rate changes and the increasing volumes, Blair forecasts revenues of $7.535 billion for the company’s current fiscal year, a figure that should grow past $8 billion in 2021.

Labcorp, of Burlington, N.C., also should see a boost in diagnostic revenues, which previously were pegged at $6.845 billion but now are projected to hit $7.2 billion in 2020. Both Labcorp and Quest are on track to outperform expectations, as is the diagnostic division of Abbott Laboratories, of Abbott Park, Ill. Still, testing for non-COVID purposes is not expected to fully recover in the near term for Quest – a reality that likely will apply to other test makers, given the slowdown in nonemergency surgical procedures and the unknown impact of back-to-work and back-to-school testing.