The American Red Cross is participating in a multi-center clinical study sponsored by IMUGEN, Inc. to help improve the safety of the nation’s blood supply.
This study will test the blood supply for evidence of a tick-borne organism, Babesia microti, by investigational test methods developed by IMUGEN. It will be conducted under Imugen’s Food and Drug Administration (FDA) approved Investigational New Drug Application (IND) and will include the testing of more than 26,000 blood donor specimens from Babesia endemic and non-endemic areas to define the performance characteristics, sensitivity, and specificity of the investigational test methods for blood donor testing. Susan Stramer, Ph.D., executive scientific officer for the American Red Cross, will act as a principal investigator for the Red Cross arm of the study.
Babesiosis is an emerging infectious disease transmitted to humans by the bite of a deer tick (the same deer tick that transmits Lyme disease). “Although some individuals infected with Babesia may become quite ill, other individuals may have minimal or no symptoms,” said Stramer. “The latter group may become blood donors and Babesia has been shown to be transmitted through transfused blood in at least 100 cases to date.”
Currently, there are no FDA licensed tests to screen blood donations for Babesia. To address this unmet need, researchers from IMUGEN have developed these tests to screen for the presence of Babesia in blood donors.
“The new investigational tests will include the detections of Babesia DNA and the presence of antibodies to Babesia in the donor blood,” said Philip Molloy, MD, medical director and principal investigator for IMUGEN. “The goal is to reduce the potential for transfusion transmitted Babesia infections, thereby improving the safety of the blood supply.”
IMUGEN’s preliminary, collaborative research over the past 2 years has yielded promising results and formed the foundation for the current generation of test methods. Following IMUGEN obtaining the required FDA regulatory approvals, we anticipate that the testing will be readily available for blood donor screening for Babesia.
About IMUGEN, Inc. Incorporated in May 1989, IMUGEN, Inc. is a clinical laboratory located in Norwood, MA with over 20 years experience in the development or performance of specialized immunoassays and nucleic acid testing assays for the testing of clinical specimens for tick-borne diseases such as Lyme disease (Borrelia burgdorferi), babesiosis (Babesia microti), anaplasmosis (Anaplasma phagocytophilum), and ehrlichiosis (Ehrlichia chaffeensis), and for blood borne infections (e.g. HIV, Hepatitis C).