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FDA cautions antibody test developers against falsely claiming tests are authorized

Posted 08 April 2020 | By Michael Mezher 

FDA cautions antibody test developers against falsely claiming tests are authorized

After opening the door to commercial manufacturers and laboratory developers to market serological tests to detect antibodies to the novel coronavirus (SARS-CoV-2), with minimal regulatory oversight, the US Food and Drug Administration (FDA) is cautioning against companies falsely claiming their tests are approved or authorized.
Public health authorities and experts around the world view serological testing as a means of identifying people who have already had COVID-19 and mounted an immune response to the virus, possibly giving them protection from future infections.
Some believe widespread serological testing could help reopen the economy more quickly and such tests will be key to identifying recovered patients who can donate convalescent plasma, a potential treatment for COVID-19.
In its immediately effective guidance laying out its policies on diagnostic tests for COVID-19 released last month, FDA carved out a separate path for certain serological tests that diverges from its approach to other types of diagnostics.
Under the policy, FDA says will not object to the development and use of serological tests without FDA review or authorization so long as the test have been validated and the agency has been notified. The policy does not apply to serology tests developed for at-home use. FDA asks that developers of serological tests provide information along with the tests stating that the tests have not been reviewed by FDA and other disclaimers about the results the tests provide.
The policy also recommends that companies looking to develop serological tests meant to diagnose or inform infection status pursue an emergency use authorization (EUA).
So far, FDA has issued just one EUA for a serological test for SARS-CoV-2 antibodies to Cellex Inc and has received notice from more than 70 developers who have made tests available under the agency’s policy who do not plan to pursue an EUA.
“FDA issued this policy to allow early patient access to certain serological tests with the understanding that the FDA has not reviewed and authorized them,” FDA Commissioner Stephen Hahn said in a statement released Monday evening.
Hahn warned that “some firms are falsely claiming that their serological tests are FDA approved or authorized, falsely claiming that they can diagnose COVID-19,” and said the agency would take “appropriate action” against any firms making false claims or marketing inaccurate or unreliable tests.
Hahn’s statement comes more than a week after a company called BodySphere falsely claimed in a press release it had received an EUA for a rapid two-minute antibody test for COVID-19. And while some serological test developers, like BioMedomics, have said they will pursue EUAs, others, like Nirmidas Biotech, have said they will not pursue an EUA.
US public health officials including White House coronavirus task force coordinator Deborah Birx and Assistant Health and Human Services Secretary Brett Giroir have also warned that some companies are marketing inaccurate serological tests for COVID-19 online.
Health officials in the UK have said they are looking for refunds after purchasing COVID-19 antibody tests after finding them to be unreliable. And the UK’s Medicines and Healthcare products Regulatory Agency on Wednesday released specification criteria for some serology tests.


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Tags: coronavirus, IVD, US

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