Home / FDA News / FDA Approves Grifols’ Procleix Babesia Assay for Donor Screening on Procleix Panther System

FDA Approves Grifols’ Procleix Babesia Assay for Donor Screening on Procleix Panther System

BARCELONA, Spain, Feb. 7, 2019 /PRNewswire/ — Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, announced today that the U.S. Food and Drug Administration (FDA) approved the Procleix Babesia assay, a qualitative assay for the detection of the ribosomal RNA from 4  Babesia species (B. microti, B. duncani, B. divergens, B. venatorum) in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion.

The assay runs on the Procleix Panther system — a fully automated platform utilizing Nucleic Acid Testing (NAT) for blood screening. The FDA approval recognizes a successful multi-center clinical trial conducted under an Investigational New Drug (IND) study at the American Red Cross, Creative Testing Solutions, and Rhode Island Blood Center (an affiliate of the New York Blood Center, Inc.), in select areas of the U.S.

“The FDA approval of the Procleix Babesia assay is the latest significant milestone for Grifols and reinforces our strong commitment to helping health professionals decrease potential risks of infection from donated blood,” said Carsten Schroeder, President of Grifols Diagnostic Commercial Division. “By monitoring new and re-emerging threats to blood supply, we continue in our mission to work with leading experts in the field and health authorities to improve patient safety by delivering innovative solutions on proven and reliable testing platforms.”

Babesia is a parasite that can be transmitted to humans by tick bites or through donated blood from Babesia-infected 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, and Minnesota.

About Procleix NAT Solutions

Today, Procleix systems are used to screen more blood donations around the world than any other NAT blood screening product, and include tests for HIV, hepatitis (A, B, C and E) viruses, West Nile virus, Zika virus and more. The Procleix Panther system automates all aspects of 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, including the U.S.

About Grifols

Grifols is a global healthcare company with more than 75 years of legacy dedicated to improving the health and well-being of people around the world. Grifols produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to help them deliver expert medical care.

Grifols’ three main divisions – Bioscience, Diagnostic and Hospital – develop, produce and market innovative products and services that are available in more than 100 countries.

With a network of approximately 250 plasma donation centers, Grifols is a leading producer of plasma-derived medicines used to treat rare, chronic and, at times, 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 compounding and control drug inventory.

Grifols is headquartered in Barcelona, Spain and has 21,000 employees in 30 countries.

In 2017, sales exceeded 4,300 million euros. Grifols demonstrates its strong commitment to advancing healthcare by allocating a significant portion 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). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the US NASDAQ via ADRs (NASDAQ: GRFS).

For more information, visit www.grifols.com.

Check Also

FDA Grants Priority Review to Merck’s sBLA for Keytruda Plus Inlyta as First-Line Treatment for Advanced Renal Cell Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced …