The FDA has granted emergency use authorization for COVID-19-related diagnostic tests to Hologic (NSDQ:HOLX) and Laboratory Corporation of America (NYSE:LH).
Hologic described its new Panther Fusion SARS-CoV-2 assay as a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19. The automated Panther high-throughput system is widely used across the U.S., can provide results in less than three hours and process up to 1,150 coronavirus tests in a 24-hour period, according to the Marlborough, Mass.-based company.
Hologic also said it expects to provide its laboratory customers with tens of thousands of SARS-CoV-2 tests this month as it ramps up production capacity. Starting in April, Hologic expects to produce nearly 600,000 SARS-CoV-2 tests per month, representing a 12-fold increase in the company’s prior manufacturing capacity for similar tests that run on the Panther Fusion system.
Panther Fusion can also simultaneously test for other common respiratory viruses, and patient samples can be loaded onto it as they arrive in the laboratory, a capability known as “random access” that improves efficiency and workflow, according to Hologic. Overall, the instrument’s high throughput and quick turnaround time will enable more patients to be tested, sooner.
Hologic was also the first company to receive support for coronavirus test development from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).
“As one of the largest molecular diagnostic companies in the world, Hologic can make a huge difference in the coronavirus pandemic with our scientific expertise and fully automated, high-throughput testing system,” said Hologic president & CEO Steve MacMillan in a news release. “As soon as the outbreak started, our diverse team of scientists and engineers began developing a new, highly accurate test, and we have brought it to market quickly through the FDA’s emergency use process and with assistance from BARDA. Just as we answered calls to help during the H1N1 and Zika virus outbreaks, we are proud to help our laboratory customers and clinicians respond to the urgent public health need for more coronavirus testing.”
Hologic also said it is making additional investments to further increase production capacity.
The FDA’s emergency use authorization now also covers Lab’sCorp COVID-19 RT-PCR test for use in the company’s Burlington, N.C. lab and other labs that are CLIA-certified to perform high-complexity tests. LabCorp said it is rapidly expanding its COVID-19 testing capacity and expects to be able to perform more than 10,000 tests per day by the end of the week and 20,000 tests per day by the end of March.
“We have been working closely with the government and others to increase test capacity and respond to this public health crisis,” the company said in a statement. “Our utmost concern is for the safety of the public, patients, healthcare service providers and our employees, and we are proud to play an important role as part of an industry consortium that is committed to meeting the growing demand for national testing.”
FDA emergency use authorization is not the same as approval or clearance. It only lasts for the duration of the FDA-declared emergency period and can be terminated or revoked earlier, according to the agency.
“We are taking steps to support diagnostic development considering the urgent need,” FDA commissioner Dr. Stephen Hahn said in a statement. “We urge state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests. Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients.”