FDA Approves Use of the Procleix Zika Virus Assay from Hologic and Grifols to Screen the U.S. Blood Supply Under an IND Study Protocol
- 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 & Emeryville, California, 20th June, 2016– 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 US 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 US 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 US 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.
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
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.
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