--Highly Accurate HSV Test Now Available Alongside Women's
Health Menu on the Fully Automated Panther System--
MARLBOROUGH, Massachusetts,
Nov. 15, 2016 /PRNewswire/ --
Hologic, Inc. (Nasdaq: HOLX) announced today that it has obtained a
CE Mark for the Company's Herpes Simplex Virus (HSV) assay,
enabling the test to be marketed in the European Union. The
Aptima® HSV 1 & 2 assay is a nucleic acid
amplification test for the qualitative detection of HSV RNA in
clinician-collected swab specimens from skin lesions.
The assay can be used to aid in the diagnosis of HSV-1 and/or
HSV-2 infections in symptomatic male and female patients. The assay
distinguishes between HSV 1 and 2, which is recommended in all
patients with first-episode genital herpes.1 Patients
with HSV-2 are at increased risk for contracting and transmitting
HIV-1 (human immunodeficiency virus).2
"Nucleic acid testing is the gold standard for detection of
infectious agents," said Joao Malagueira, VP Sales Diagnostics,
International. "Providing physicians with accurate diagnoses --
specifically distinguishing between HSV 1 and 2 -- is critical to
choosing effective treatment regimens and advising patients of
their additional risks."
The Aptima HSV 1 & 2 assay runs on Hologic's
Panther® system, a market-leading, integrated platform
that fully automates all aspects of molecular testing, from sample
to result. The system substantially reduces hands-on time for
laboratories by providing random and continuous access with rapid
turnaround time. Lesion samples can be collected using either the
Aptima Multitest Swab Collection Kit or a commercially available
Viral Transport Medium collection kit.
The Aptima HSV 1 & 2 assay joins a growing list of CE-Marked
assays available on the Panther system, which includes a virology
menu (HIV-1, Hepatitis C Virus, Hepatitis B Virus) and tests for
Sexually Transmitted Infections (chlamydia/gonorrhea, Trichomonas
and M. genitalium).
"Labs increasingly are looking to consolidate testing onto a
single platform, and by expanding the number of tests available on
Panther, we are helping these customers become more efficient,"
said Malagueira.
To learn more about the Aptima HSV 1 & 2 assay, please visit
http://www.hologic.com/products/clinical-diagnostics-and-blood-screening/assays-and-tests/aptima-hsv-1-2-assay.
The HSV assay is not intended for use with cerebrospinal fluid
or for prenatal screening. The Aptima HSV 1 & 2, HIV-1, HBV,
HCV, and M. genitalium 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.
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.
1Patel 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.
2Freeman 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
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