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FDA grants Hologic emergency authorization for asymptomatic COVID testing

The U.S. Food and Drug Administration has provided emergency use authorization for Hologic’s Panther Fusion SARS-CoV-2 assay on people who show no symptoms of the coronavirus, the Marlborough medical technology company announced on Monday.

Testing asymptomatic people and those who may have been exposed to the coronavirus is a key part of tracking the virus’ spread, the company said in a press release.

“The high accuracy of molecular testing has made it the gold standard for infectious disease detection, and recent data demonstrate that Hologic’s molecular coronavirus tests are among the most sensitive available,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic, in a statement.

The company is also seeking emergency use authorization for one of its other molecular diagnostic tests for COVID-19, the Aptima SARS-CoV-2 assay.

– Digital Partners -

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