FDA releases approved Covid-19 test kits

Pablo Tucker
March 20, 2020

The molecular diagnostic company said a revised FDA policy on COVID-19 diagnostic testing that was announced Monday will allow the company to "aggressively expand" its presence in the U.S. "Leaders including President Trump and Health and Human Services Secretary Alex Azar early in the outbreak appeared unable or unwilling to envision a crisis of the scale that has now emerged, and no one stepped up to effectively coordinate among federal agencies or the private-sector labs, medical providers, and manufacturers needed for a large-scale testing push, they say".

The March 16 policy could be the biggest revision yet. Abbott said it plans to distribute around 150,000 tests to customers in the United States immediately.

Due to the change in the policy, Co-Diagnostics' test kit will soon be available for use by and marketed to a wide array of USA laboratories without first requiring Emergency Use Authorization, the company said.

RT-PCR-based tests for COVID-19 seem to be the most common available from developers and while very sensitive, they do have some issues that could affect accuracy.

These have not been approved for commercial use.

In a third change, the FDA provided guidance to developers of serological tests, which test the blood for signs of coronavirus infection.

With respect to allowing states to regulate diagnostics, Hahn said that the policy would only extend to those states that wish to take on oversight themselves, like NY. The objective of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health emergency. Public health authorities say accurate and widespread testing is critical in identifying COVID-19 hotspots and how it is spreading, as well as ensuring infected patients are treated quickly. Under the first prong, FDA has indicated that it will not object to a laboratory's use of SARS-CoV-2 diagnostic tests (i) that occurs after validation and notification to the agency, (ii) for a reasonable time (about 15 business days), (iii) while preparing an EUA request, (iv) provided that the laboratory is certified and meets certain regulatory requirements under Clinical Laboratory Improvement Amendments (CLIA). In addition to the EUA process which is already an expedited authorization process, the new policies will further accelerate distribution and use of the tests. Finally, FDA recommends including a general statement in the test report that FDA review is pending, whenever that is the case. But the agency said it has changed its approach based on the evolving nature of the coronavirus pandemic and in an effort to make more tests available.

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