MARLBOROUGH, Mass.,
Sept. 8, 2016 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S.
Food and Drug Administration (FDA) has expanded the emergency use
authorization (EUA) for the company's Aptima® Zika virus
diagnostic assay to be used with urine samples (collected alongside
patient-matched serum or plasma specimens).
Hologic's Zika virus assay was authorized for emergency use with
serum and plasma (blood) samples in June 2016. Its new use
with urine samples lengthens the time period during which patients
can be tested for Zika from seven days to 14 days following
symptoms, as recommended by the U.S. Centers for Disease Control
and Prevention (CDC).
"This action by FDA is significant because it gives many more
people the opportunity to be tested with our highly sensitive
assay," said Tom West, Division
President of Diagnostic Solutions at Hologic. "In particular, this
expanded indication allows us to better serve public health labs,
increasing access to more people to detect and diagnose more
disease."
The Aptima Zika Virus assay runs on Hologic's
Panther® system, a market-leading, integrated platform
that fully automates all aspects of nucleic acid amplification
testing. By reducing hands-on time, the Panther system helps to
minimize labor needs and the potential for manual errors. The
Aptima Zika Virus assay is available for use in all 50 states,
Puerto Rico and U.S.
territories.
"We are driven to provide solutions to some of society's most
urgent unmet health needs," said Steve
MacMillan, Chairman, President and Chief Executive Officer
of Hologic. "The suspension of the Medical Device Excise Tax
enabled us to make additional investments in research and
development and accelerate availability of this critically
important test."
The Aptima Zika Virus assay is a molecular diagnostic tool for
the qualitative detection of RNA from Zika virus in human
specimens. The Aptima Zika Virus assay has not been FDA cleared or
approved, and is only authorized for use for the duration of the
FDA's 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 is designed to be used in
individuals meeting CDC's 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.
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 perinatally and through sexual contact, and
transmission by blood transfusion is a strong possibility according
to the U.S. Centers for Disease Control and Prevention.1
The CDC 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.2,3
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. Local mosquito-borne Zika
virus disease cases have been confirmed in Florida Miami-Dade and
Broward counties4, and
there have been travel-associated cases in Florida and a number of other U.S. 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 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.
1 http://www.cdc.gov/zika/transmission/index.html
2Cao-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.
3W. 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.
4http://www.floridahealth.gov/diseases-and-conditions/zika-virus
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
(585) 355-5978
jane.mazur@hologic.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/fda-expands-emergency-use-authorization-for-hologics-aptima-zika-virus-assay-to-include-use-with-urine-samples-300324970.html
SOURCE Hologic, Inc.