-- The CE-marked Aptima® Mycoplasma genitalium Assay on the
Panther® System Identifies a Prevalent, Often Misdiagnosed
Sexually Transmitted Infection --
MARLBOROUGH, Massachusetts,
Dec. 16, 2015 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) announced today the European
launch of the CE-marked Aptima Mycoplasma genitalium assay, adding
to the growing menu of molecular tests available on the fully
automated Panther system.
"Until now, a fully automated, sample-to-result nucleic acid
amplification test (NAAT) had not been available to detect M.
genitalium, a common sexually transmitted infection (STI)
that is frequently misdiagnosed," said Claus Egstrand, Hologic
Group President, International. "Now, clinicians and laboratories
can test for this STI alone or from the same sample used for other
STI testing."
M. genitalium was originally isolated in
1980.1 Since then, many studies have explored the
prevalence of the infection, which can be present in up to 6% of
men and women visiting STD clinics.2 It is associated
with urethritis in men and women, and with cervicitis and pelvic
inflammatory disease in women.3 Data also supports a
correlation between M. genitalium infection and increased
HIV-1 infection and transmission.4 Until now,
identifying this elusive pathogen has been difficult because of its
symptomatic similarities to other STIs, and due to limitations
associated with traditional diagnostic approaches.
Accurate identification of M. genitalium is essential for
successful treatment, as the infection can become resistant to
antibiotics used to treat similar STIs.4 The Aptima
Mycoplasma genitalium assay on the Panther system allows healthcare
providers to diagnose and more effectively treat this STI.
The Aptima Mycoplasma genitalium assay further expands the test
menu available on the Panther system, joining assays for HCV,
HIV-1, HBV, HPV, chlamydia, gonorrhea and trichomoniasis. The assay
may be used to test multiple sample types, including vaginal swabs,
urine, unisex swabs or ThinPrep® Pap test vials, and will soon be
available for use with multitest swabs for male meatal samples.
The Aptima Mycoplasma genitalium assay, Aptima HCV Quant Dx
assay, Aptima HIV-1 Quant Dx assay and Aptima HBV Quant assay are
not 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, The Science of Sure, Aptima, Panther, ThinPrep and
associated logos are trademarks and/or registered trademarks of
Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
Forward-Looking Statements
This news release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of the Hologic Aptima Mycoplasma genitalium assay and the
Panther system. There can be no assurance that 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 guarantee that these products will be adopted by
customers 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.
References: 1. Jensen JS. Mycoplasma genitalium: the
aetiological agent of urethritis and other sexually transmitted
diseases. J Eur Acad Dermatol Venereol. 2004;18(1):1-11.
2. Anagrius C, et al. Mycoplasma genitalium:
prevalence, clinical significance, and transmission. Sex Transm
Infect. 2005;81:458-62. doi:10.1136/sti.2004.012062. 3.
Manhart LE, et al. Mycoplasma genitalium: Should We Treat
and How? Clin Infect Dis. 2011;53(S3):S129-S142.
doi:10.1093/cid/cir702. 4. Taylor-Robinson D, et al.
Mycoplasma genitalium: from Chrysalis to Multicolored Butterfly.
Clin Microbiol Rev. 2011;24(3):498-514.
doi:10.1128/CMR.00006-11.
Contact:
Michael Watts
Vice President, Investor Relations and Corporate Communications
(858) 410-8588