Imugen Presents Study Findings for Tests to Identify Babesia Infection in Blood Donors

Initial results of Imugens new investigational blood tests to screen blood donors for babesiosis were presented at the annual scientific sessions of the American Association of Blood Banks (AABB), held in Boston in October. Data from the Imugen studies were summarized at several podium presentations. Susan Stramer, PhD, current president of the AABB and the executive scientific officer of the American Red Cross, Erin Moritz, MS, PhD, of the American Red Cross, and Philip Molloy, MD, medical director of Imugen, presented some study findings. At the time of the 2012 AABB meeting, approximately 20,000 blood donors had been tested for Babesia microti parasites by nucleic acid tests and also by a new serologic test method.

Babesia organisms, which infect red blood cells, are typically transmitted to humans by the bite of an infected deer tick. The clinical presentation of babesiosis is variable. Individuals may be asymptomatic; and as blood donors, could unknowingly transmit the organism to patients by blood transfusions. Babesiosis is currently the most common infectious disease transmitted by blood in the United States.

Imugen and the American Red Cross are conducting studies on the incidence and prevalence of Babesia in blood donations and follow up studies on patients who have received blood transfusions with potentially infectious units. The efficacy of these newly developed tests is also being evaluated. The laboratory studies have focused on blood donors who reside in areas highly endemic for babesiosis (northeastern region of the U.S.), as well as blood donors from moderately endemic and traditionally non-endemic areas within the United States. Additional institutions participating in the research include the Memorial Blood Centers of Minnesota and the Rhode Island Blood Center; with data presented by Jed Gorlin, MD and Carolyn Young, MD, respectively.

As a result of this testing, 69 blood units that were potentially infectious for Babesia were removed from the blood supply.

These findings suggest that a testing protocol for identifying Babesia infected blood donors is feasible, and has the potential to remove infectious units from the blood supply and reduce the likelihood of transfusion transmitted babesiosis.

Data from these studies, which are expected to conclude in early 2013, will be utilized for an application for test licensure by the FDA.