Biotech Values

[DewDiligence]

…the [Biocentury] article published on April 10 may already be outdated. It states that Cellex is the only company to receive EUA for Covid-19 antibody test. But, it seems that Hardy is distributing a test produced by AutoBio.

The Biocentury article points out that FDA authorization (EUA) is not needed for companies to launch COVID-19 antibody tests; from the same article:

https://www.biocentury.com/article/304887

FDA’s March 16th guidance on COVID-19 diagnostics opened the runway for serological tests to launch in the U.S. without FDA review under certain conditions. Such tests had already been made available by Chinese, Korean, Singaporean and European regulators weeks before.

“That’s really the impetus for why you’re seeing a flood of these tests coming into the market,” said Troy Hopps, point-of-care diagnostic leader at Becton Dickinson and Co. (NYSE:BDX), which co-launched a rapid serology test with BioMedomics Inc. on March 31.

FDA’s rationale for not requiring regulatory review is that the tests can’t be used to diagnose disease, are less complex than molecular diagnostics, and are needed as soon as possible.