FDA Publishes New Monkeypox and Medical Devices Web Page
The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes information on diagnostic testing, Laboratory Developed Tests (LDTs), and information for test developers. With more than 22,000 confirmed Monkeypox cases in the U.S., the new Monkeypox Medical Devices web comes as FDA takes significant actions to increase Monkeypox testing capacity nationwide following the Secretary of Health and Human Services’ August 9th announcement of public health emergency.
The FDA’s guidance issued for test developers under Policy for Monkeypox Tests to Address the Public Health Emergency describes, among other things, review priorities of Emergency Use Authorization (EUA) requests for monkeypox diagnostic tests. And, on the same day as the FDA guidance was issued, the FDA also issued the first EUA to a commercially available monkeypox test in the United States to Quest Diagnostics for its Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR device. “With this FDA emergency authorization, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus,” said Jay G. Wohlgemuth, M.D., Senior Vice President, R&D, Medical and Chief Medical Officer, Quest Diagnostic.
Quest Diagnostics is not the only company that has been working on monkeypox diagnostic test kits. Earlier in June, Becton Dickinson announced partnership with CerTest Biotec to collaborate on molecular diagnostic test for monkeypox. Several other healthcare and pharmaceuticals companies have also been linked with this effort. This comes at a time when many of these companies are preparing for a drop in revenue from COVID-19 testing as the threat of COVID-19 reduces.
FDA grants Emergency Use Authorization to Quest Diagnostics for Zika Test
According to Medical Device Daily, the US Food and Drug Administration (FDA) has authorized the emergency use of a diagnostic molecular test developed by Quest Diagnostics subsidiary, Focus Diagnostics Inc., in response to growing concerns over the recent Zika virus outbreak. According to the report, this is the first test from a commercial lab to receive emergency use authorization to test U.S. patients for the Zika virus. It could potentially significantly broaden the access of U.S. physicians to diagnose the virus, as previously Zika tests were limited to qualified CDC-designed laboratories. As a result, more patients can be screened and individuals with the disease can be identified earlier.
According to the FDA, Quest’s Zika Virus RNA Qualitative Real-Time RT-PCR test is intended for the qualitative detection of Zika virus RNA in human serum approximately 4-7 days following onset of symptoms, which include fever, joint pain, rash, or conjunctivitis. In particular, the CDC recommends testing for individuals with symptoms suggestive of Zika infection who have traveled within the last two weeks to an area with ongoing transmission, asymptomatic pregnant women with a history of residence in or travel to areas of active Zika infection, asymptomatic pregnant women whose male sexual partners have traveled to or lived in an area of active Zika infection, and infants born to mothers who live in or traveled to areas with Zika virus transmission during their pregnancy – including both molecular and serologic testing of infants who are being evaluated for evidence of a congenital Zika virus infection.
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