MARLBOROUGH, Mass.,
June 17, 2016 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S.
Food and Drug Administration (FDA) granted emergency use
authorization for the company's new, diagnostic assay for Zika
virus infection. The Aptima® Zika Virus assay is a
molecular diagnostic tool for the qualitative detection of RNA from
Zika virus in human serum and plasma specimens. The Aptima Zika
Virus assay has not been FDA cleared or approved and is only
authorized for use 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.
The Aptima Zika Virus assay runs on the Hologic
Panther® system, a market-leading, integrated platform
that fully automates all aspects of nucleic acid amplification
testing. The Panther system substantially reduces hands-on time for
laboratories, minimizing the labor required and the potential for
manual errors. The Aptima Zika Virus assay will be available for
use in all 50 states, Puerto Rico
and U.S. territories, expanding the number of public and
private labs that can test for the virus.
"We want to ensure that during this critical summer season and
beyond, those at risk for the Zika virus have an opportunity to be
tested with a highly sensitive assay," said Edward Evantash, M.D., medical director and vice
president, Medical Affairs at Hologic. "Our new test will help to
ensure accurate diagnoses and reduce subsequent spread of the
infection."
The Aptima Zika Virus assay is designed to be used in
individuals meeting Centers for Disease Control and Prevention
(CDC) Zika virus clinical criteria (e.g., clinical signs and
symptoms associated with Zika virus infection) and/or CDC Zika
virus epidemiological criteria (e.g., history of residence in or
travel to a geographic region with active Zika transmission at the
time of travel, or other epidemiologic criteria for which Zika
virus testing may be indicated), by laboratories in the United States that are certified under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42
U.S.C. § 263a, to perform high complexity tests, or by similarly
qualified non-U.S. laboratories.
"Our new Aptima Zika Virus assay is another reflection of our
commitment to developing cutting-edge diagnostics that provide
solutions for urgent unmet needs," said Tom
West, division president, Diagnostic Solutions at Hologic.
"Running the Aptima Zika Virus assay on the Panther system will
offer quick results to epidemiologists and laboratories, which is
likely to help both healthcare providers and their patients."
To learn more about the Aptima Zika Virus assay, please visit
www.hologic.com/zika.
About Zika Virus
According to the World Health
Organization, Zika virus is an emerging mosquito-borne virus that
was first identified in rhesus monkeys in Uganda in 1947 and in humans in 1952.
Outbreaks of Zika virus disease have been recorded in Africa, the Americas, Asia and the Pacific. Zika virus is
transmitted to people primarily through the bite of an infected
mosquito from the Aedes genus, mainly Aedes aegypti
in tropical regions. This is the same mosquito that transmits
dengue, chikungunya and yellow fever. Zika virus can also be
transmitted through sexual contact and transmission by blood
transfusion and perinatal transmission are currently being
investigated. The U.S. Centers for Disease Control and Prevention
is also investigating the link between Zika virus and
Guillain-Barré syndrome, a serious and sometimes fatal
muscle-wasting disease, and has stated that Guillain-Barré syndrome
is "very likely triggered" by Zika in a small proportion of
infections.1,2
According to the U.S. Centers for Disease Control and
Prevention, local mosquito-borne transmission of Zika virus in U.S.
territories has been reported in the Commonwealth of Puerto Rico, the U.S. Virgin Islands, and American Samoa. No local mosquito-borne Zika
virus disease cases have been reported in U.S. states, but there
have been travel-associated cases.
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 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 trademarks
(or registered trademarks) of Hologic, Inc. in the United States and/or other countries.
1Cao-Lormeau VM, et al. Guillain-Barré syndrome
outbreak associated with Zika virus infection in French Polynesia: a case–control study. Lancet
http://dx.doi.org/10.1016/S0140-6736(16)00562-6.
2W. Rasmussen SA, et al. Zika Virus and Birth Defects –
Reviewing the Evidence for Causality. CDC. Zika and Guillain-Barré
Syndrome. http://www.cdc.gov/zika/about/gbs-qa.html. Updated
April 14, 2016. Accessed June 1, 2016.
Hologic Investor Contact
Michael Watts
Vice President, Investor Relations and Corporate Communications
(858) 410-8588
michael.watts@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.