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Despite a decade of tightly regulating testing, the FDA is now allowing companies to proceed with their diagnostic tests for COVID-19 without first submitting them for federal review or obtaining an official emergency clearance. In the past, the FDA has warned of the personal health risks that could follow erroneous test results as lab-developed tests and complex molecular diagnostics have become common tools in guiding clinical practice.

The FDA’s position toward regulation of testing for the last 10 years has changed in the light of warnings from epidemiologists who estimate that the United States 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 18 has reported more than 36,000 confirmed cases and 2,978 deaths. The governor of Italy’s hardest hit Lombardy region said that numbers are not falling and “soon” they will be unable to treat those who fall ill.

FDA Commissioner Stephen Hahn said the agency’s device center has been in continual contact with diagnostic developers since January — providing technical assistance to test developers to help facilitate the availability and distribution of tests so that healthcare professionals can accurately detect the COVID-19 virus.

“Since the beginning of this outbreak, more than 90 test developers have sought FDA guidance with the development and validation of tests they plan to bring through the EUA process,” Hahn said. “Additionally, more than 40 laboratories have notified us that they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency.”

He said the FDA wants to expand the capacity, as well as the variety of COVID-19 molecular diagnostics available, and that the agency is 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 stated. “Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients.”

The new, if only temporary, 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.

Roche and Thermo Fisher have completed the Emergency Use Authorization process. The FDA has also approved the coronavirus tests from Hologic and LabCorp. BD has submitted its own test in collaboration with BioGX.

The FDA has delegated oversight authority to state health departments nationwide, similar to what it has already done in New York. The agency is allowing state officials to authorize the use of new lab-developed tests directly, and those labs will not have to engage with the agency’s review process.

The agency also provided recommendations for test developers focused on detecting relevant antibodies in the bloodstream to spot new cases — instead of nucleic acids linked to the SARS-CoV-2 virus itself taken from nasal or oral swabs.

Hahn said these serological tests are less complex than molecular diagnostics and that it does not intend to object to their unreviewed use, as long as they have been validated and include warning statements saying they should not be used as the sole method of diagnosing a coronavirus infection.

“The ramifications of this new FDA policy are significant for our company,” said Dwight Egan, CEO of Co-Diagnostics, which received a CE mark for its COVID-19 test in late February. The Salt Lake City-based company said it previously shipped its test to specific CLIA-certified labs under the old policy, but now it will available in the U.S. on a wider scale without an emergency use authorization.

“We applaud the FDA’s decision to recognize the dire need for increased access to high-quality COVID-19 tests, and to adapt as the situation demands in light of a public health emergency,” Egan said.


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Larry Storer

Larry Storer

Larry Storer has been editor of Vein Therapy News for 10 years. He has edited computer, shelter and medical publications at Publications & Communications LP for 30 years. He was also a corporate vice president and editorial director before retiring. Larry graduated from Baylor University with a BA in journalism and an MA in communications; and from Lamar University with a MED in school administration. He taught beginning and advanced reporting, beginning and advanced editing and editorial writing at Baylor University. Larry was a reporter, and city and news editor of the Beaumont Journal, and opinion editor at the Beaumont Enterprise and Beaumont Enterprise-Journal. He was also the founding managing editor of the Yuba City (California) Daily Independent-Herald.