Hologic has completed regulatory filings needed to make Panther Trax widely available, a molecular diagnostics platform that offers random access and full automation for molecular testing.

Panther Trax provides a broad assay menu that includes tests for women’s health, sexually transmitted infections (STIs), respiratory health, viral load and COVID-19 testing, as well as Open Access functionality for laboratory developed tests (LDTs).

Panther Trax is now listed as a Class I medical device with the United States Food and Drug Administration, CE-marked for diagnostic use in Europe, and will also be commercially available in Canada, Australia and New Zealand. Launch of Panther Trax represents the latest addition to the Panther Scalable Solutions (PSS) portfolio of products.

“Clinical laboratories have performed heroically, meeting unprecedented demand for close to two years now due to the COVID-19 pandemic,” says Kevin Thornal, president, Diagnostic Solutions Division at Hologic. “It is the job of manufacturers like Hologic to continue to innovate and enable our lab partners to accomplish more with less, ensuring they manage their workloads while responding to further potential surges in COVID testing.”

The Panther system, initially launched in Europe in 2010, will now be available for a multiple countries and regions following the completed regulatory filings.

The Panther Trac broad menu of services enables labs to consolidate molecular testing onto a single platform. The Panther system serves as the foundation for optional add-ons including: Panther Fusion, which launched in 2017 and provides additional IVD menu and the Open Access functionality to run LDTs; Panther Plus, which gives labs greater flexibility, walk-away time and throughput; and Panther Link, which virtually connects multiple instruments to share data and reagents while providing a centralized dashboard to monitor all instruments.