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. “Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients.”
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.
The decision also comes after the first diagnostic industry giants have completed the Emergency Use Authorization process—Roche and Thermo Fisher. The FDA has also granted official green lights to Hologic and LabCorp for their coronavirus tests, while BD announced it submitted its own version in collaboration with BioGX.
“Our device center has been in continual contact with the medical device community, in particular diagnostic developers, since January—providing technical assistance to test developers to help facilitate the availability and distribution of tests so that health care professionals can accurately detect the COVID-19 virus,” Hahn said.
“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,” he added. “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.”
Additionally, 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.
The FDA 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.
According to the Centers for Disease Control and Prevention, more than 25,000 specimens have been analyzed at federal and other public health labs since mid-January, although it is unclear how many individual patients that translates to with different numbers of specimens being used per person over time.
“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; 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.
Editor's note: This story has been updated with additional comment from Co-Diagnostics.