Friday, March 20, 2020

FDA allows commercial coronavirus testing

FDA opens the gates to commercial coronavirus testing without agency review | Fierce Biotech - Conor Hale:

Mar 17, 2020 - "In the face of urgent need, the FDA has opened its floodgates to commercial coronavirus testing. The agency is now allowing companies to proceed with their diagnostic tests without first submitting them for federal review or obtaining an official emergency clearance.

"The move comes as epidemiologists estimate that the U.S. is just days behind seeing large-scale spread of the virus similar to what is currently happening in countries such as Italy — which as of March 17 has reported nearly 28,000 confirmed cases, the most outside of China, while the U.S. now stands at over 4,600 cases, according to international health authorities.

"Tens of companies have already signed up to test under the new 'unprecedented policy,' according to Commissioner Stephen Hahn, who said the FDA aims to expand the capacity as well as the variety of COVID-19 molecular diagnostics available — and that the agency is, essentially, trusting companies and labs to make sure their tests in the field are well-validated. 'We urge state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests,' Hahn said in an agency statement....

"The policy is a broad expansion in scope from the FDA’s previous moves to accelerate testing, including allowing certain CLIA-certified, 'high complexity' labs to proceed with their own tests while submitting their data and emergency use application to the agency for review within 15 days. Commercial developers will be held to the same paperwork requirement.

"It is also a dramatic, if temporary, change in the FDA’s stance toward regulation of testing, which over the past 10 years has warned of the personal health risks that could follow erroneous test results as lab-developed tests and complex molecular diagnostics have become much more common tools in guiding clinical practice."

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