The FDA continues to expand its Emergency Use Authorization (EUA) for COVID-19 testing, moves that could help diagnostic companies enter the US market more quickly. But test makers will still have to conduct robust verification if they want to ensure the tests remain available after the public health emergency subsides.
EUAs are a tool used by the FDA when a public health emergency has been declared and the secretary of HHS determines that circumstances exist to justify the authorization of use for certain medical products. An EUA allows unapproved medical products or unapproved uses of marketed medical products to be used in an emergency to diagnose, treat or prevent serious, life-threatening disease or conditions.
Testing for evidence of SARS-CoV-2, the coronavirus that causes the respiratory infectious disease COVID-19, has been slow to launch in the US due to mishaps with a test developed by the CDC.
On March 10, Dr. Robert Redfield, director of the CDC, testified before Congress that fewer than 5,000 people had been tested by public health labs in the US to date. The American Enterprise Institute has estimated that the US, as of March 10, has the capacity to test about 16,000 patients a day when considering all types of labs.
With the SARS-CoV-2 novel coronavirus, FDA has issued two EUAs—one related to testing and one for non-FDA-approved respirators. The latter allows for the use of certain National Institute for Occupational Safety and Health-approved respirators to be used by healthcare personnel (there are concerns the US health workforce will be short on masks and respirators as the crisis develops).
The EUA for testing allows for the use of diagnostic tests that have not gone through the FDA’s in vitro diagnostic (IVD) review. The diagnostic test EUA was first issued on Feb. 6 and expanded the use of the CDC’s real-time polymerase chain reaction (RT PCR) SARS-CoV-2 test to CDC-qualified labs.
The FDA has twice updated this EUA, first on Feb. 29 to allow certain labs to use their own laboratory-developed test to diagnose patients. On March 6, the FDA added to its active EUAs website a template for companies to develop in vitro diagnostic (IVD) test kits for SARS-CoV-2 detection.
Companies and institutions that wish to submit a diagnostic for the EUA can fill in the blanks in the template if their test uses similar technologies, such as RT PCR and respiratory specimens. Companies and institutions that plan to develop tests based on alternative technologies or specimens are asked to contact the FDA directly.
Manufacturers may have to provide clinical samples, but based on the FDA’s final EUA guidance issued in 2017, these samples can be from patients in or outside the US. The guidance also states that an EUA could be granted for a test that is approved in a foreign country or by an international organization such as the World Health Organization.
As of March 10, the FDA’s website had listed just two SARS-CoV-2 tests that have been authorized for emergency use.
However, at a March 7 press conference, FDA Commissioner Dr. Stephen Hahn said that the agency has received over 100 requests for the new template. “Of those, 36 sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process,” Hahn said.
“Our door is open for any developers who want to have a test for use in the US,” he added.
The FDA’s EUA process could provide opportunities for domestic and foreign diagnostic manufacturers to develop IVDs for SARS-CoV-2. However, as the FDA stated in its 2017 guidance and in its recent EUA announcements for the novel coronavirus, the EUA “is not a pathway to permanent marketing of your device.”
In its template, the FDA encourages companies to pursue full approval for their diagnostic as the test is being used under the EUA. “We strongly recommend that you consider, in addition to the EUA, a traditional premarket submission for your IVD so that your device can still be legally marketed after termination of the emergency declaration.”
The FDA issued an EUA for Zika virus diagnostics in 2016, under which 15 tests were authorized. Three tests have subsequently undergone premarket submission and received full FDA clearance. According to the FDA’s EUA website there are nine different public health emergencies where EUAs are still active, including the COVID-19 outbreak and Zika.