To broaden capacity and access to coronavirus diagnostics in the U.S., the FDA issued a new policy over the weekend allowing “high-complexity” laboratories—such as certain academic medical centers and other institutions—to develop and operate their own tests.
The policy authorizes CLIA-certified laboratories to immediately field molecular diagnostic tests validated for the disease, known as COVID-19, before any agency review or approval of requests for an official Emergency Use Authorization.
“We believe this policy strikes the right balance during this public health emergency,” FDA Commissioner Stephen Hahn said in an agency statement. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S.”
“We are not changing our standards for issuing Emergency Use Authorizations,” Hahn added. “This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”
While the pace of new cases in mainland China has slowed over recent days, the virus has begun to spread in Europe, the Middle East and the U.S.—which last week confirmed its first cases of unknown origin, suggesting new disease transmission through local communities.
The country also saw its first death, in Seattle, out of 72 known U.S. patients. International health organizations have confirmed over 87,400 cases worldwide, with recent flare-ups in South Korea, Italy and Iran.
Meanwhile, the Centers for Disease Control and Prevention updated its own guidance, which could increase the demand for tests. The criteria now include healthcare personnel or any person that has had direct contact with a COVID-19 patient in the two weeks since they’ve shown symptoms—or anyone who has been within six feet of a patient for a prolonged period of time.
“[The FDA’s] step may reduce development costs, speed the process for availability at more testing sites, incentivize private development and, ultimately, help save lives,” said Rick Bright, director of the U.S. government’s Biomedical Advanced Research and Development Authority.
“At BARDA, we are identifying industry partners to develop rapid diagnostics that can be used in commercial and hospital labs or even doctors’ offices so that medical professionals and their patients have the information they need to take action,” said Bright.
The FDA also published new guidance and templates for diagnostics developers that provide some technical details on how to confirm the performance of their COVID-19 tests and recommends that laboratories double-check the first five positive and first five negative clinical results.
After the test has been validated, labs should notify the FDA of its use and submit a completed emergency authorization request within 15 business days.