Hologic Launches Panther Trax for High Volume Molecular Testing

Rhea-AI Summary

Hologic (NASDAQ: HOLX) has completed necessary regulatory filings for its new automation solution, Panther Trax, which will enhance testing capabilities in laboratories. This product is now recognized as a Class I medical device by the FDA and CE-marked in Europe, with plans for availability in Canada, Australia, and New Zealand. The Panther system supports various molecular tests, including for COVID-19, and aims to assist labs in managing increased testing demands effectively. Its scalable solutions will enable labs to optimize space and cost-efficiency while expanding testing volume.

Positive

• Completion of regulatory filings for Panther Trax enhances market readiness.
• Panther Trax is designated as a Class I medical device by the FDA and CE-marked in Europe.
• Expands Panther's capabilities to support high-volume testing for COVID-19 and other diagnostics.
• Offers customizable lab automation solutions to optimize efficiency and reduce operational costs.

Negative

• None.

Panther Trax offers full automation to meet high volume testing demands; will be commercially available in the United States, Europe, Canada, Australia and New Zealand

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Hologic (Nasdaq: HOLX) announced today that 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.

For more information about the Panther system, visit https://www.hologic.com/hologic-products/diagnostic-solutions/instrumentation.

About the 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.

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Hologic Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic, Panther, Panther Fusion, Panther Link, Panther Plus and The Science of Sure are registered trademarks of Hologic, Inc. in the United States and/or other countries.

SOURCE: Hologic, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211223005107/en/

Investor Contact:

Ryan M. Simon

Vice President, Investor Relations

+1 858.410.8514 (direct)

ryan.simon@hologic.com



Media Contact:

Jane Mazur

Vice President, Corporate Communications

+1 508.263.8764 (direct)

+1 585.355.5978 (mobile)

jane.mazur@hologic.com

Source: Hologic, Inc.

FAQ

What is Panther Trax by Hologic?

Panther Trax is a new automation solution designed to enhance testing capabilities in laboratories, allowing for increased testing volumes without additional staff.

When will Panther Trax be available?

Panther Trax will be commercially available in the United States, Europe, Canada, Australia, and New Zealand.

What regulatory approvals has Panther Trax received?

Panther Trax has been designated as a Class I medical device by the FDA and is CE-marked for diagnostic use in Europe.

How does Panther Trax benefit clinical laboratories?

It allows labs to automate processes, increase testing volumes, and manage workloads effectively while optimizing space and costs.

What types of tests can be performed using the Panther system?

The Panther system supports a broad range of tests, including those for women’s health, STIs, respiratory health, and COVID-19.