Thread by @davidalim

NEW: @US_FDA issues immediate guidance to allow high-complexity labs to create their own #COVID19 tests, which @POLITICO reported yesterday.

Allow labs to immediately use tests BEFORE the agency grants an emergency use authorization.

Document here: fda.gov/media/135659/d…

@US_FDA @politico “We believe this action will support laboratories across the country working on this urgent public health situation," medical device chief regulator Jeff Shuren said.

Labs still must validate tests prior to use - and a disclaimer that FDA review is pending must be given.

@US_FDA @politico FDA wants labs to submit a full EUA request within 15 business days that an assay is successfully validated.

Ultimately - this move to expand #COVID19 testing comes after weeks of difficulty by public health labs to validate CDC's diagnostic:
politico.com/news/2020/02/2…

@US_FDA @politico This explains why CDC's @DrNancyM_CDC suggested on yesterday's press call that ALL local labs could have capacity to test for the #COVID19 by the end of next week.

The move also tracks closely with what former FDA Commissioner @ScottGottliebMD has called for.

@US_FDA @politico @DrNancyM_CDC @ScottGottliebMD One question I have to figure out the answer to is how many high-complexity Clinical Laboratory Improvement Amendments labs there are.

There are more than 250,000 U.S. CLIA labs - but how many are able to do high-complexity tests?

cms.gov/Regulations-an…

I am told from an industry source that in 2014, there were around 11,000 CLIA high-complexity labs.

But that source cautions that not all of those labs are relevant and it would be inaccurate to assume that many would have the required tech/expertise to do #COVID19 testing.