Hologic's Panther Fusion® MRSA Assay Now CE Marked in Europe

MARLBOROUGH, Massachusetts, July 5, 2018 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that its Panther Fusion^® MRSA assay has received CE-mark in Europe. This assay, the latest in a growing menu of Panther Fusion® and Aptima® assays, brings full automation, efficiency and excellent assay performance to MRSA screening. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, and is suitable to any size laboratory.

"The launch of the Panther Fusion^® MRSA assay demonstrates our commitment to expanding the portfolio of assays available for Panther Fusion, enabling our European customers to deliver a better service to their clients and ultimately to patients," said João Malagueira, Vice President Diagnostics EMEA.  "With rising antibiotic resistance in Europe and the threat posed by healthcare-associated infections to public health, our new assay will help customers provide a rapid service to hospitals, so cases of resistance, such as MRSA, are identified and managed quickly and effectively."

The Panther Fusion MRSA assay accurately detects and differentiates Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from ESwab™ nasal samples. It has broad strain inclusivity including the Bengal Bay clone, and is able to correctly identify empty cassette variants.

The Panther Fusion^® MRSA assay enables laboratory customers to leverage the benefits of the fully automated Panther Fusion system, which provides random and continuous access to improve laboratory efficiency. Laboratories can combine Women's Health, Virology, Respiratory, Hospital-Acquired Infections, and Open Access® tests on the Panther Fusion system, running up to 32 different assays at the same time. In addition, MRSA samples can be loaded directly into the Panther Fusion, saving customers vital time and labor costs and delivering first results in 2.4 hours, considerably faster than commonly used culture and lab developed tests.  In addition, Panther Fusion offers labs the potential to process up to 500 Panther Fusion and Aptima assays in an 8-hour period.

Panther Fusion is available as a full system, or the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities. The Panther Fusion module adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry that powers the Company's Aptima® brand.  Key benefits include the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time, continuous loading, and STAT capabilities. Its ready to use, unit-dose lyophilized reagents, which have 60-day on-board stability, help reduce waste and the need for manual reagent preparation.

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.

Forward-Looking Statements

This news 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, 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 [email protected].

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

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