FDA has granted emergency use authorization (EUA) for Marlborough, Mass-based Hologic’s Panther Fusion SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease.
Hospital, public health, and reference laboratories can perform the test on Hologic’s Panther Fusion system, a fully automated, high-throughput molecular diagnostic platform that is widely used across the United States. Each Panther Fusion system can provide results in less than 3 hours and process up to 1,150 coronavirus tests in a 24-hour period.
Steve MacMillan, Hologic.
Using the Panther Fusion system, healthcare providers can test for SARS-CoV-2 from the same patient sample and collection vial that they currently use to diagnose other common respiratory viruses whose symptoms overlap with COVID-19, boosting efficiency and increasing clinical insight. The Panther Fusion system is already widely used in low-, medium-, and high-throughput laboratories.
“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,” says Steve MacMillan, chairman, president, and chief executive officer of Hologic. “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 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.”
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