--Blood banks will use the new test, co-developed by Hologic and
Grifols, to screen donated blood in potential endemic areas of the
US--
--Test will run on the Procleix Panther System, a fully
automated NAT blood screening platform--
MARLBOROUGH, Massachusetts
and EMERYVILLE, California,
June 20, 2016 /PRNewswire/ --
Hologic, Inc. (NASDAQ: HOLX) and Grifols (MCE: GRF,
MCE: GRF.P and NASDAQ: GRFS) – market-leading partners committed to
blood safety - announced today that the U.S. Food and Drug
Administration (FDA) has approved use of the Procleix Zika
virus blood screening assay on the Procleix Panther system under
the agency's Investigational New Drug (IND) study protocol.
Prominent U.S. blood centers will use the Procleix Zika virus
assay to screen donated blood collected in potential endemic areas
of the southern U.S., and may expand testing to other areas of the
U.S. if the virus continues to spread.
"The American Red Cross is pleased to participate in the
Procleix Zika Virus assay investigational study, which will allow
us to begin blood donor testing for Zika virus early this summer in
areas most likely to have local mosquito transmission of the
virus," said Susan Stramer, Ph.D.,
Vice President of Scientific Affairs at the American Red Cross.
"Working together, we remain committed to ensuring the safety and
availability of the U.S. blood supply for patients in need."
"Zika virus is a rapidly growing threat to public health," said
Tom West, Division President,
Diagnostic Solutions at Hologic. "Today's announcement demonstrates
our ability to quickly develop molecular diagnostics in response to
new and emerging pathogens."
"As a global leader in Transfusion Medicine," said Carsten Schroeder, President of the Grifols
Diagnostic Division, "Grifols is proud to serve blood banks and
healthcare professionals working around the world to ensure
patients receive safe blood transfusions."
About Procleix NAT Solutions
The Grifols Procleix
portfolio of nucleic acid technology (NAT) products are developed
as part of a long-standing partnership between Hologic and Grifols.
Today, Procleix systems are used to screen more blood donations
around the world than any other NAT blood screening products, and
include tests for HIV, hepatitis, West Nile virus and more.
The Procleix Panther system automates all aspects of nucleic
acid testing (NAT)-based blood screening on a single, integrated
platform. It eliminates the need for batch processing and combines
walk-away freedom with intuitive design for ease of use. The system
has received regulatory approvals in countries around the world,
and is in development for the U.S. market.
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. However, sexual transmission
of Zika virus is also possible. Other modes of transmission such as
blood transfusion and perinatal transmission are currently being
investigated. In total, 64 countries and territories have reported
transmission of Zika virus since 1 January
2007.
According to the U.S. Centers for Disease Control and
Prevention, local mosquito-borne transmission of Zika virus in US
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 US states, but there have
been travel-associated cases.
About Grifols
Grifols is a global healthcare company
with more than 75-year history of improving people's health and
well-being through the development of protein therapies and
diagnostic and hospital pharmacy products. The company is present
in more than 100 countries worldwide and its headquarters are
located in Barcelona, Spain. As a
recognized leader in transfusion medicine, Grifols offers a
comprehensive range of transfusion medicine, hemostasis, and
immunoassay solutions for clinical laboratories, blood banks, and
transfusion centers. For more information about Grifols, visit
www.grifols.com
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 approaches to blood
screening. There can be no assurance these approaches 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 approaches 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 and Panther are trademarks (or registered trademarks) of
Hologic, Inc. in the United States
and/or other countries.
Procleix is a trademark (or registered trademark) of
Grifols.
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
Grifols Media Contact
Melinda
Baker
Director, Corporate Communications
+1 (510) 923-5070
melinda.baker@grifols.com