Sunday, March 1, 2020

February 29: FDA Emergency Guidance on COVID-19 Testing under CLIA

On February 29, 2019, FDA issued an emergency bulletin allowing high complexity CLIA labs to performed locally developed testing for COVID-19.    The bulletin is here; open access coverage at Genomeweb is here.   See also coverage at MedTechDive, here.  For rapid FDA clearance of a New York State test, Genomeweb here.  For an update at WSJ through March 3, here.

For a March 4 update at Genomeweb, here; for a March 5 update at Genomeweb, here.

Large amounts of LDT high complexity CLIA lab testing is already routine in microbiology, and nationwide, without special permission.  With this bulletin the FDA, I think, is being sure to stay ahead of the policy skirmishes on this one.  AACC provides some backstory.

AACC has a webpage dedicated to coronavirus issues, here.   AACC specifically notes in a February 28 open letter to the FDA that an FDA Emergency Edict had not only allowed certain urgent new rules for approved emergency use [good], but proactively barred any other labs from doing tests outside that rule (here) [bad].  I believe AACC wanted CLIA-regulated LDTs and FDA emergency use tests to proceed in parallel in this urgent period.


On Genomeweb, I noted a COVID-19 qPCR webinar scheduled for March 23, sponsored by Co-Diagnostics (Featherstone & Satterfield), here.