The following is a press release submitted to SOURCE media through its business wire service.
MARLBOROUGH – Hologic announced this month it has completed regulatory filings needed to make Panther Trax® available in a number of countries and regions.
Launch of Panther Trax represents the latest addition to the Panther® Scalable Solutions (PSS) portfolio of products, offering the ultimate in lab automation by physically linking multiple Panther instruments together into a single, powerful workcell that allows labs to increase testing volumes without increasing staff.
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.
“Clinical laboratories have performed heroically, meeting unprecedented demand for close to two years now due to the COVID-19 pandemic,” said 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, offers random access and full automation for molecular testing. It 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). This broad menu 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.
These scalable solutions address the needs of today’s laboratories, allowing them to increase operational capacity and testing volumes at their own pace, while building on the flexibility, and streamlined user experience they require. With Panther Trax, labs can customize configuration to meet space constraints and minimize facility costs. Taken together, the suite of Panther Scalable Solutions offered by Hologic significantly expands upon the proven performance and reliability of the foundational Panther system.
The Panther system for molecular diagnostics is a best-in-class fully automated, sample-to-result platform with adaptable workflow options and consolidated testing menu. The Panther Fusion system provides an expanded in-vitro diagnostics (IVD) menu, as well as Open Access functionality to run LDTs. Hologic’s Panther and Panther Fusion systems now offer 19 FDA-cleared assays and up to 22 assays outside the U.S. depending on the region. This high-throughput molecular diagnostic platform combines comprehensive sexual health, cervical health, viral load, respiratory testing and open channel functionality on a fully automated system.
Hologic, Inc. is a Marlborough-based medical technology company primarily focused on improving women’s health and well-being through early detection and treatment.