Barcelona, Spain, / today / –Grifols a leading global manufacturer of plasma-derived drugs and a leader in the development of innovative diagnostic solutions, today announced that the US Food and Drug Administration (FDA) approved the Procleix Babesia assay, a qualitative test for the 39; identification of ribosomal RNA from 4 Babesia species (B. microti, B. duncani, B. divergens, B. venatorum) in individual samples or up to 16 samples lysed in pools of human donors, including donors of whole blood and blood components for transfusion.
The test is performed on the Procleix Panther system, a fully automated platform that uses Nucleic Acid Testing (NAT) for blood screening. FDA approval recognizes a successful multi-center clinical trial conducted in the Investigational New Drug (IND) study at the American Red Cross, Creative Testing Solutions and Rhode Island Blood Center (a New York Blood subsidiary Center, Inc.), in certain areas of the United States
"The FDA's approval of the Procleix Babesia essay is the last significant milestone for Grifols and reinforces our strong commitment to helping health professionals reduce the potential risks of donated blood", he said Carsten Schroeder, President of the Grifols Commercial Diagnostic Division. "By monitoring the new and re-emerging threats to blood supply, we continue our mission to work with leading experts in the field and health authorities to improve patient safety by offering innovative solutions on proven and reliable test platforms."
Babesia it is a parasite that can be transmitted to humans by tick bites or through the blood donated by BabesiaInfected donors According to the Centers for Disease Control and Prevention (CDC), the highest numbers of Babesia infections occurred in Massachusetts, New York, Connecticut, Rhode Island, New Jersey, Maine, New Hampshire, Wisconsin, is Minnesota.
Information on Procleix NAT solutions
Today, Procleix systems are used to analyze more blood donations worldwide than any other NAT blood screening product and include tests for HIV, hepatitis (A, B, C, and E), of the West Nile virus, Zika virus and more. The Procleix Panther system automates all aspects of NAT-based blood screening on a single, integrated platform. Eliminates the need for batch processing and combines remote freedom with an intuitive design for ease of use. The system has received regulatory approvals in countries all over the world, including the United States.
Grifols is a global healthcare company with over 75 years of heritage dedicated to improving the health and well-being of people around the world. Grifols manufactures essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to help them provide specialist medical care.
The three main divisions of Grifols – Bioscience, Diagnostic and Hospital – develop, produce and market innovative products and services available in over 100 countries.
With a network of around 250 plasma donation centers, Grifols is a leading producer of plasma-derived drugs used to treat rare, chronic and sometimes life-threatening conditions. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of diagnostic products designed to support safety from donation through transfusion. The hospital division provides intravenous (IV) therapies, clinical nutrition products and hospital pharmacy systems, including systems that automate drug inventory and drug control.
Grifols is based in Barcelona, Spain and has 21,000 employees in 30 countries.
In 2017, sales have exceeded 4,300 million euros. Grifols demonstrates its strong commitment to promoting health care by allocating a significant part of its annual income to research, development and innovation.
The company's Class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE: GRF). Class B non-voting Grifols are listed on the Mercado Continuo (MCE: GRF.P) and on the US NASDAQ through ADR (NASDAQ: GRFS).
For more information, visit grifols.com.
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