July 21, 2010, Scottsdale AZ—Creative Testing Solutions (a blood donor testing collaboration between Blood Systems and Florida Blood Services) and Blood Systems have announced their plans to work with Immunetics, Inc. to develop a donor screening test for Babesia.
Babesia is a tick-borne parasite that causes a malaria-like disease called Babesiosis. In the US, it is most common in the Northeast and upper Midwest. While the disease is rare, it can be severe and even fatal, especially for elderly or immunocompromised patients and people who have had their spleen removed.
Babesiosis can be transmitted by blood transfusion. Between 2005 and 2008, the US Food and Drug Administration reported nine fatalities related to transfusion-transmitted Babesiosis. There currently is no FDA licensed donor screening test available.
The project calls for Immunetics to develop assays for detecting Babesia antibodies, including an ELISA assay for screening and a Western Blot assay for confirmation. Creative Testing Solutions will develop equipment and software systems for a high-volume automated application of the ELISA assay.
Blood Systems will provide funding for the test development phase of the project. Immunetics will contribute expertise in Babesia immunoassays and proprietary ELISA technology. Based on initial results, Immunetics, Creative Testing Solutions and Blood Systems will enter into discussions to determine the feasibility of performing a clinical trial of the Babesia assays to support a submission to FDA for regulatory approval for blood screening.
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About Creative Testing Solutions: Creative Testing Solutions (myCTS.org) tests approximately 25 percent of the U.S. blood supply in three laboratories located in Dallas, Phoenix and Tampa.
About Blood Systems: Blood Systems (bloodsystems.org) is one of the nation’s oldest and largest non-profit community blood service providers and operates community blood centers serving nearly 600 hospitals in 20 states, biological products distribution services, a quality consulting group and a world-renowned transfusion medicine research institute.
About: Immunetics, Inc.: Immunetics (immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and pathogen detection and, for more than 10 years, has been a leading innovator of tests for bacterial, viral and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. Its mission is better, cost-efficient care through more accurate diagnosis.
