MARLBOROUGH, Mass.
, June 20, 2017
/PRNewswire/ -- Hologic, Inc.
(Nasdaq: HOLX) announced today that it has obtained FDA clearance
to market the Aptima®
Herpes Simplex Virus (HSV) 1 & 2 molecular assay on the
fully automated Panther® system. The test will be commercially
available in the 50 United States, U.S. territories and
Puerto Rico. According to the U.S.
Centers for Disease Control and Prevention, infections with HSV-2,
the herpes strain with more serious health implications, affect
more than 24 million Americans.1
The Aptima HSV 1 & 2 assay can be used to
qualitatively detect, and differentiate between, HSV-1 and HSV-2.
Specimens collected in a broad range of transport media, including
the Aptima specimen transport medium, can be tested with the
assay.
"Helping our clinical lab customers consolidate testing on
the Panther system enables them to be more efficient and
productive," said Tom West,
president of the Diagnostic Solutions Division at Hologic. "By
partnering with our customers, we'll be better able to offer more
people high-quality and faster testing results and improve
detection of STIs like herpes. This new product clearance reflects
our commitment to providing healthcare professionals and patients
with greater certainty and peace of mind."
The HSV assay joins a growing list of
molecular tests available on Hologic's Panther system, a
market-leading, integrated platform that fully automates molecular
testing for laboratories. The Panther system substantially reduces
hands-on time for laboratories by providing random and continuous
access with rapid turnaround time. Many U.S.-based laboratories
today conduct HSV testing via live culture, which is both
time-consuming, with additional manual steps, and slow, delivering
results in days rather than hours. In addition, studies show that
HSV molecular diagnostic tests are three to five times more
sensitive than live culture samples.2
Hologic estimates that tests run on the Panther system
benefit more than 40 million people worldwide annually.3
These include assays for other sexually transmitted infections
(such as Human papillomavirus, Chlamydia trachomatis/Neisseria
gonorrhea, Trichomonas vaginalis) and a virology menu (including
HIV-1 and Hepatitis C Viruses).
How the new assay works
The Aptima HSV 1 & 2 assay is a nucleic acid
amplification test for the qualitative detection and
differentiation of HSV types 1 and 2 in clinician-collected swab
specimens from anogenital skin lesions. These samples
can be collected using either the new Aptima Multitest Swab
Specimen Collection Kit or commercially available viral transport
media. The Aptima Multitest Swab Specimen Collection Kit offers
healthcare providers greater versatility in sample
collection.
The assay can be used to aid in the diagnosis of HSV-1
and/or HSV-2 infections in symptomatic women and men. It
distinguishes between HSV 1 and 2, which is recommended in all
patients with first-episode genital herpes.4 Patients
with HSV-2 are at increased risk for contracting and transmitting
HIV-1 (human immunodeficiency virus).5 Pregnant women
infected with HSV-2 are at risk of transmitting the virus to their
babies during birth, which can cause neurological
complications.
To learn more about the Aptima HSV 1 & 2 assay, please
visit
http://www.hologic.com/products/clinical-diagnostics/assays-and-tests/aptima-hsv-1-2-assay
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 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.
1https://www.cdc.gov/std/stats/sti-estimates-fact-sheet-feb-2013.pdf
2Hook EW. A new look at genital
herpes: the critical role of the laboratory in diagnosis and
management. MLO Med Lab Obs. 2012;44(7):8.
3Internal Hologic
estimates
4Patel R, et al. 2010 European
Guideline for the Management of Genital Herpes. IUSTI/WHO European
STD Guidelines Editorial Board.
http://www.iusti.org/regions/europe/pdf/2010/Euro_Guideline_2010_herpes.pdf.
Published 2010. Accessed August 30,
2016.
5Freeman EE, et al. Herpes simplex
virus 2 infection increases HIV acquisition in men and women:
systematic review and meta-analysis of longitudinal studies.
AIDS. 2006;20(1):73-83.
Hologic Investor
Contact
Justin
Gaudreau
Senior Manager, Investor
Relations
1 (508)
263-8952
justin.gaudreau@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.