--
FDA clearance makes clinically validated assay available
for sexually-transmitted infection listed as emerging threat by the CDC
--
MARLBOROUGH, Mass.--(BUSINESS WIRE)--
Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug
Administration (FDA) has granted clearance for its Aptima® Mycoplasma
genitalium assay, the first and only FDA-cleared test to detect this
under-recognized but increasingly common sexually transmitted infection
(STI). This newest Aptima assay joins a growing suite of market-leading
tests offered by Hologic to help combat the rise of STIs in the U.S.
This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20190123005868/en/
Aptima® Mycoplasma genitalium assay, the first and only FDA-cleared test to detect this under-recognized but increasingly common sexually transmitted infection (Photo: Business Wire)
Hologic’s first-in-category assay, cleared through the FDA’s De Novo
request process, provides laboratories with a highly sensitive and
specific molecular diagnostic method to identify infections and enable
effective treatment.
First discovered in the early 1980s, Mycoplasma genitalium (M.
genitalium) was listed as an emerging public health threat by the
U.S. Centers for Disease Control and Prevention (CDC) in 2015.1,2 Current
estimates indicate that M. genitalium may affect more than 15
percent of men and women in certain high-risk populations, and its
prevalence is growing.3 Because of the lack of an FDA-cleared
test until now, M. genitalium has often been misdiagnosed as
other STIs and, in some cases, treated with the wrong antibiotics. This
often leaves the underlying infection untreated, which can lead to
increased transmission and recurrent infections.
“Although Mycoplasma genitalium is typically more common than
gonorrhea, there is very little public awareness of this rising sexually
transmitted infection, which can cause serious and potentially
devastating health problems,” said Damon Getman, Ph.D., senior principal
research scientist and director of research at Hologic. “The
introduction of the Aptima Mycoplasma genitalium assay gives
healthcare professionals the opportunity to provide optimal care for
their patients and reflects Hologic’s commitment to developing
innovative solutions that address emerging public health threats.”
In men, M. genitalium symptoms may include urethritis, the
swelling and inflammation of the urethra. In women, M. genitalium
has been linked to cervicitis, the swelling and inflammation of the
cervix.4,5 If left untreated, infections can lead to
infertility in women and increased risk of HIV acquisition and
transmission.2,6 Patients infected with M. genitalium
may be asymptomatic or experience symptoms similar to those associated
with a chlamydial infection, so accurate diagnostic tests are critical
to help healthcare professionals and their laboratory partners identify
these bacterial infections and treat them appropriately. Research has
shown as many as 50 percent of women and 42 percent of men with M.
genitalium may have an antibiotic-resistant strain, further
emphasizing the importance of early detection and regular screening.3
“We are tremendously proud of the team of scientists and engineers who
developed this assay,” said Tom West, Hologic’s division president,
Diagnostic Solutions. “They exemplify Hologic’s dedication to help arm
laboratories and healthcare professionals with superior diagnostic tools
to identify harmful infections, and this FDA clearance represents
another milestone in furthering that mission.”
In published research, Hologic’s ribosomal RNA-based M. genitalium
assay displayed greater sensitivity than lab-developed or CE-marked
DNA-based tests .7,8 Hologic introduced the first FDA-cleared
diagnostic test kit for STIs in the 1990s using its innovative RNA-based
technology. Since then, Hologic has expanded its Aptima STI portfolio to
include assays for chlamydia, gonorrhea, human papillomavirus (HPV),
herpes simplex viruses (HSV 1&2), trichomonas, and Zika* virus. The
Aptima virology portfolio also includes quantitative assays for the
human immunodeficiency virus (HIV) and hepatitis B and C (HBV and HCV).
All are available on Hologic’s fully-automated Panther®system.
In 2017, the Aptima assays helped an estimated 40 million patients
obtain fast, high-quality test results.9
Including the first IVD for the detection of Mycoplasma genitalium,
Hologic’s Panther and Panther Fusion® system now offers 14
FDA-cleared or approved assays that detect more than 20 pathogens,
making it the only high-throughput molecular diagnostic platform in the
United States to combine comprehensive sexual health, cervical health,
viral load, respiratory testing and open channel10
functionality on a fully automated system.
For more information on the Aptima assays, visit https://healthdxs.com/en/.
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.
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, Panther and Panther Fusion are
registered trademarks of Hologic, Inc. in the United States and/or other
countries.
SOURCE: Hologic, Inc.
* The Aptima Zika Virus assay has not been FDA cleared or approved; this
test has been authorized by FDA under an EUA for use by authorized
laboratories; this test has been authorized only for the detection of
RNA from Zika virus and diagnosis of Zika virus infection, not for any
other viruses or pathogens; and this test is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of in vitro diagnostic tests for
detection of Zika virus and/or diagnosis of Zika virus infection under
section 564(b)(1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner. For additional
availability in other countries beyond the U.S., please contact your
local sales representatives or distributor.
__________________________________
1 Tully JG, Taylor-Robinson D, Cole RM, et al. A newly
discovered mycoplasma in the human urogenital tract. Lancet 1981;1:
1288–91.
2 CDC. 2015 Sexually Transmitted Diseases Treatment
Guidelines. Emerging Issues. https://www.cdc.gov/std/tg2015/emerging.htm.
Updated June 4, 2015. Accessed December 7, 2018.
3 Getman D, Jiang A, O’Donnell M, et al. Mycoplasma
genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance
Frequency in a Multicenter Clinical Study Cohort in the United States.
Journal of Clinical Microbiology. 2016; 54(9):2278-2283.
4 Horner P, Martin D. Mycoplasma genitalium infection in men.
Journal of Infectious Diseases. 2017. 216 (Suppl 2), S396.
5 Wiesenfeld H, Manhart L. Mycoplasma genitalium in Women:
Current knowledge and research priorities for this recently emerged
pathogen. Journal of Infectious Diseases. 2017. 216 (Suppl 2), S389.
6 Gatski M, Martin DH, Theall K, et al. Mycoplasma genitalium
infection among HIV-positive women: prevalence, risk factors and
association with vaginal shedding. International Journal of STD & AIDS.
2011; 22: 155–159.
7 Unemo M, Salado-Rasmussen K, Hansen M, et al. Clinical and
analytical evaluation of the new Aptima Mycoplasma genitalium assay,
with data on M. genitalium prevalence and antimicrobial resistance in M.
genitalium in Denmark, Norway and Sweden in 2016. Clinical Microbiology
and Infection. 2018. 24, 533-539.
8 Le Roy C, Pereyre S, Henin N, et al. French Prospective
Clinical Evaluation of the Aptima Mycoplasma genitalium CE-IVD Assay and
Macrolide Resistance Detection Using Three Distinct Assays. Journal of
Clinical Microbiology. 2017. 55, 3194-3200.
9 Hologic internal estimate.
10 Open channel functionality on the Panther system is a
non-IVD function, which is not cleared or approved by the FDA.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20190123005868/en/
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
Source: Hologic, Inc.