MARLBOROUGH, Mass.,
Feb. 15, 2017 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) announced today that the
United States Food and Drug Administration (FDA) has granted PMA
approval for the Company's hepatitis C virus (HCV) assay for
quantitation of HCV viral load and confirming active HCV infection
on the fully automated Panther® system.
"HCV therapeutic options continue to evolve rapidly with highly
effective antiviral medications that are transforming treatment of
the disease, with cure rates above 90%," said Tom West, president, Diagnostic Solutions
Division at Hologic. "The expanded use of the Aptima HCV Quant Dx
assay to confirm active HCV infection in addition to viral load
quantitation will help physicians more quickly determine the best
treatment options and help improve patient care."
The Aptima HCV Quant Dx assay uses real-time
transcription-mediated amplification (TMA), which provides highly
sensitive and specific performance for diagnostic use, as well as
reliable quantitation for determination of sustained antiviral
response across all major genotypes and a wide linear range. The
assay runs on the Panther system, which provides full sample to
answer automation and substantially reduces hands-on time with
random and continuous access.
The Aptima HCV Quant Dx assay joins a growing list of tests
available on the Panther system in the U.S. market. In
addition to an HIV-1 (human immunodeficiency virus) viral load
assay, the Panther menu includes tests for sexually transmitted
infections – chlamydia, gonorrhea, trichomonas and human
papillomavirus (HPV).
"Menu consolidation is increasingly important to clinical
laboratories in their efforts to increase efficiency of
operations," said West. "Expanding the range of assays that can be
run on the Panther system with offerings in virology, in addition
to women's health, will help our customers reach their goals."
Hologic has a long-term legacy in the virology space, beginning
two decades ago and spanning development of nucleic acid tests to
screen the blood supply for HIV, HCV and HBV, an expertise that was
applied to the development of the viral load portfolio on the
Panther system.
In Europe, the Aptima HCV Quant
Dx assay is CE-IVD marked for diagnostic and viral load
monitoring, as is the Aptima HIV-1 Quant Dx assay. The Aptima HBV
(hepatitis B) Quant assay is CE-IVD marked for viral load
monitoring but is not currently approved for sale in the United States. To learn more about the
Aptima Quant assays available in the
United States, please visit http://usaptimavirology.com.
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.
Hologic Investor Contact
Michael
Watts
Vice President, Investor Relations and Corporate
Communications
+1 (858) 410-8588
michael.watts@hologic.com
Hologic Media Contact
Jane Mazur
Senior Director, Divisional Communications
+1 (585) 355-5978
jane.mazur@hologic.com
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SOURCE Hologic, Inc.