Hologic Obtains Canadian Approval for Aptima® Hepatitis C and B Quant Assays

MARLBOROUGH, Mass., Nov. 10, 2016 /CNW/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that it has obtained approval from Health Canada for the Company's hepatitis C and B assays. The Aptima^® HCV and HBV Quant assays are nucleic acid amplification tests for the quantitative detection of RNA from hepatitis C, and DNA from hepatitis B-infected patients.  These assays supplement the already available Aptima HIV-1 Quant assay, rounding out the Company's virology portfolio on the Panther^® system in Canada.  

The Aptima HCV and HBV Quant assays provide excellent performance in sensitivity and precision parameters, along with sample-to-result automation on the Panther system. Both assays provide coverage across a wide linear range and employ multiple layers of protection for viral detection and quantitation across all major genotypes. 

"The evolution of the hepatitis C treatment landscape has enabled clinicians to better manage the disease, and the Aptima HCV Quant Dx assay plays an essential role by aiding in the diagnosis of infection and evaluating patients' response to antiviral therapy," said Tom West, president, Diagnostic Solutions Division at Hologic. "For HBV, our test provides accurate, reliable monitoring that contributes to the selection of effective treatment." 

The Aptima HCV and HBV Quant assays run on Hologic's Panther system, a market-leading, integrated platform that fully automates all aspects of testing. The system substantially reduces hands-on time for laboratories by providing random and continuous access with rapid turnaround time. With the Panther system, laboratorians can run viral load assays for HIV-1, HCV and HBV in parallel and from a single patient sample. 

"Laboratories are increasingly seeking to consolidate menu onto a single platform," said West. "Increasing the range of assays that can be run on the Panther system helps labs reach their efficiency objectives."

The Aptima HCV and HBV Quant assays join a growing list of tests available on the Panther system in the Canadian market, which includes an HIV-1 viral load assay and a menu of tests for sexually transmitted infections (chlamydia/gonorrhea, trichomonas and HPV (human papillomavirus).

To learn more about the Aptima HIV, HCV and HBV Quant assays, please visit http://www.hologic.com/products/clinical-diagnostics-and-blood-screening/assays-and-tests.

The Aptima HIV-1, HCV, and HBV Quant assays are not currently available for sale in the United States.                                                                                                                                                                

About Hologic
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. 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, The Science of Sure, Aptima and Panther are registered trademarks of Hologic, Inc. in the United States and/or other countries.

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SOURCE Hologic, Inc.