FDA continues to tweak regulatory path for SARS-CoV-2 testing

Lisa LaMotta Editor-in-Chief, Risk & Regulatory, PwC US June 04, 2020

As states reopen and the curve begins to flatten in many places across the US, the FDA is taking further steps to expand the use and accuracy of diagnostic testing for SARS-CoV-2, the virus that causes COVID-19.

In the last days of May, the agency took two steps to bring down barriers to testing. The first was a SARS-CoV-2 reference panel for commercial and laboratory developers of diagnostic tests for clinical use—not research. Nucleic acid diagnostic tests work by identifying the genetic material of the virus; the FDA’s reference panel provides test developers with that genetic material.

“Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance,” said the FDA in a statement.

The agency has said that it is trying to “remain flexible” during the pandemic and that it is continually evaluating its policies, particularly in relation to poorly performing diagnostic tests. The FDA considers reference panels to be an invaluable tool in validating diagnostic tests. It has used this approach with success in recent history with the Zika virus. The agency was first able to provide a reference panel for Zika molecular-based diagnostic testing, and then a reference panel of human plasma samples to support serological testing for the disease.

The second step the agency took to support testing was the issuance of an Emergency Use Authorization (EUA) template for at-home sample collection kits. The template provides test manufacturers with the information and data they will need to submit an EUA request.

Developers can offer a COVID-19 test for at-home self-collection only under an EUA or as part of an institutional review board (IRB)-approved study. “Home collection raises unique concerns about safety and accuracy,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement, pointing to possible errors in collecting the sample as well as instability issues that could occur during the shipping process.

“An at-home test that returns false results could be harmful to an individual patient, and hinder broader public health efforts to mitigate the spread of COVID-19,” Shuren added.

HRI impact analysis

The FDA has authorized several COVID-19 tests that use at-home sampling collection either through an EUA or an IRB-approved study. Yet no tests are authorized for complete at-home use.

The current pandemic has pushed the FDA and other healthcare agencies to quickly reassess how they handle disease testing. The need for rapid response in this case required an equally rapid deregulation of many protocols—some that have since been clawed back.

Many protocols being established will function as a template for future health emergencies. Testing has been called the backbone of a solid response to the spread of COVID-19. After months of inadequate testing, the nation has started testing at the numbers it should to help reopen the economy and to put the right resources in place. Making testing more accessible to consumers furthers national goals of overcoming the virus.

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