MARLBOROUGH, Mass. and EMERYVILLE, Calif., 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
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SOURCE Hologic, Inc.