Hologic's New Panther Fusion® System, Flu and Respiratory Assays Now CE Marked in Europe

MARLBOROUGH, Mass., June 29, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) has obtained a CE mark in Europe for its new Panther Fusion system and Panther Fusion assays for flu and respiratory testing, the Company announced today. The Fusion module system offers laboratories the ability to extend the testing capabilities of the existing Panther system.

The Panther Fusion module is an in-lab upgrade to the Panther^® instrument. This addition adds the flexibility of PCR (polymerase chain reaction) to the proven performance of TMA (transcription-mediated amplification), which is used by the Panther system.  Offering labs multiple chemistries on a single platform enables further consolidation of their lab testing portfolio. The Panther Fusion system retains all the key benefits of the Panther platform, including fully automated sample-to-result automation, multiple tests from a single sample, random access sample processing, continuous loading, and STAT capabilities.

Additional benefits include a higher throughput of up to 335 Panther Fusion tests in eight hours, or up to 500 Fusion and Aptima^® tests. Flexibility is also improved with the addition of Open Access functionality to run laboratory-developed tests and protocols.  This new capability allows laboratories to concentrate on developing assays, while the Panther Fusion system automates workflow and reduces overall hands-on-time.

"The Panther Fusion system, the latest innovation from our Diagnostics division, creates an integrated workflow that provides our customers with enhanced flexibility and increased efficiency," said João Malagueira, VP Sales Diagnostics, EMEA. "The addition of the flu and respiratory assays to the broad menu of Aptima tests already available for the Panther instrument further extends the range of diagnostics tests that laboratories can run on one Hologic system. Hologic's flu and respiratory assays enable customers to run only the targets requested for a patient, allowing for personalized testing and helping them control costs within their laboratories."

The Panther Fusion respiratory panel assays include the Panther Fusion Flu A/B/RSV, Panther Fusion Paraflu, and Panther Fusion AdV/hMPV/RV tests.  The Panther Fusion respiratory assays offer a modular approach to syndromic testing via the ability to run one, two or all three assays from a single patient specimen depending on the needs of a given patient.

The new Panther Fusion PCR assays, combined with the Aptima TMA assays, make the Panther Fusion system the only instrument worldwide that combines TMA, real-time TMA and real-time PCR with full sample to result automation.

The Panther Fusion system and Panther Fusion assays have not been cleared for marketing by the U.S. Food and Drug Administration, and are not available for diagnostic use in the United States

About Hologic, Inc.

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

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic 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, as the actual effect of the use of the products can only be determined on a case-by-case basis. 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 data or statements are based.

This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to womenshealth@hologic.com.

Hologic Media Contact:
Jane Mazur
508.263.8764 (direct)
585.355.5978 (mobile)
jane.mazur@hologic.com

Hologic Investor Contact:
Michael Watts
Vice President, Investor Relations and Corporate Communications
(858) 410-8588
michael.watts@hologic.com

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SOURCE Hologic, Inc.