MARLBOROUGH, Mass.,
Jan. 25, 2018 /PRNewswire/ --
Hologic, Inc. (Nasdaq: HOLX) announced today that the United States
Food and Drug Administration (FDA) has granted PMA approval for the
Aptima® HBV Quant Assay for quantitation of hepatitis B
viral load on the fully automated Panther® system.
The Aptima HBV Quant assay represents the newest addition to the
Panther system's viral load menu, joining the previously approved
Aptima HIV-1 Quant Assay (for human immunodeficiency virus) and
Aptima HCV Quant Dx Assay (for hepatitis C virus). All three
new assays use Hologic's proprietary real-time
transcription-mediated amplification (TMA), which provides highly
sensitive and specific performance. The HBV Quant assay reliably
quantitates HBV DNA across all major genotypes A-H.
"This approval represents a milestone for Hologic's growing
virology assay menu," said Tom West,
president, Diagnostic Solutions division at Hologic. "We now have
available on a single system the three major viral load assays that
most laboratories are asked to run for patients."
These Aptima assays run on the Panther system, which provides
full, sample-to-result automation and substantially reduces
hands-on time with random and continuous access. With the Panther
system, laboratorians can now run viral load assays for HIV-1, HCV
and HBV in parallel, or even from a single patient sample.
The Aptima HBV Quant assay offers a unique, dual-target approach
that delivers accurate quantitation over a broad linear range and
tolerates potential mutations in the HBV genome. The Aptima HBV
Quant assay's linear range is one of the broadest on the market
(from 10 IU/mL to 1 billion IU/mL). This helps ensure precise
quantitation even for samples with the high viremia often
associated with chronic HBV infection.
The HBV assay joins a growing menu of tests available on the
Panther system in the U.S. market. In addition to the three viral
load assays, the Panther menu includes tests for sexually
transmitted infections including chlamydia, gonorrhea, trichomonas,
human papillomavirus (HPV), and herpes simplex virus (HSV).
"We hear repeatedly from clinical laboratory customers that menu
consolidation is a top priority," said West. "Offering a robust
virology and women's health menu on a single automated platform
will enable them to reach their efficiency 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. This expertise
was applied to the development of the viral load portfolio on the
Panther system.
To learn more about the Aptima Quant assays available in
the United States, please visit
http://usaptimavirology.com.
In Europe, the Aptima HBV Quant
assay is CE-IVD marked for viral load monitoring. In addition, both
the Aptima HIV-1 Quant Dx assay and Aptima HCV Quant Dx assays are
approved in Europe for both
diagnosis and viral load monitoring.
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.
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, Aptima and The Science of Sure are trademarks
and/or registered trademarks of Hologic, Inc. in the United States and/or other countries.
Investor Contact:
Michael
Watts
+1 858.410.8588
michael.watts@hologic.com
Media Contact:
Jane
Mazur
+1 508.263.8764 (direct)
+1 585.355.5978 (mobile)
jane.mazur@hologic.com
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SOURCE Hologic, Inc.