Marlborough medical device manufacturer Hologic, Inc. on Thursday announced its Panther Trax device passed a series of regulatory tests making it commercially available in international markets.
Originally launched in Europe in 2010, the Panther Trax device offers access and full automation for molecular testing which can be used to test for women’s health issues, sexually transmitted infections, respiratory health, viral load, and COVID-19, according to the release.
The United States Food and Drug Administration has classified Panther Trax as a Class I medical device.
In addition to the United States and Europe, the diagnostic tool will now be commercially available in Canada, Australia, and New Zealand.
“Clinical laboratories have performed heroically, meeting unprecedented demand for close to two years now due to the COVID-19 pandemic,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic.
