Immunetics, Inc., has received a $3.7 million, two year SBIR contract from the National Heart, Lung and Blood Institute, an agency of the National Institutes of Health (NIH), to support clinical trials of a new blood screening test for Babesia infection.
“When the screening test identifies antibody-reactive donors, we will enroll and conduct rigorous testing of donation-derived and follow-up samples from those donors so that we can more fully understand the natural history of Babesia infection in asymptomatic donors”
"Babesia is among the top infectious threats to blood safety and, at present, there is no licensed test available. The NIH contract will allow us to address this gap in blood safety with the first cost-effective test designed for high-throughput screening of the blood supply. We are honored to have been entrusted by NIH to carry out this public health mission," said Andrew E. Levin, Ph.D., Immunetics Chief Executive Officer and Scientific Director.
Babesia is a parasite which is transmitted by the same ticks that transmit Lyme disease. While it is often asymptomatic in healthy people, Babesia infection can lead to severe or fatal illness, especially in immunocompromised patients. The parasites can remain viable in blood donations and infect transfusion recipients. In recent years, nine fatal cases of transfusion-transmitted babesiosis have been reported. Surveillance carried out by the Centers for Disease Control and Prevention (CDC) revealed over 1,000 cases of infection nationwide in 2011 — a number that appears to be growing. The US Food & Drug Administration (FDA) sponsored a workshop in 2008 focused on Babesiosis as an emerging threat to the blood supply, and the Blood Products Advisory Committee convened a meeting in 2010 to advise the FDA on approaches to blood screening for Babesia.
The contract award will enable Immunetics to bring its Babesia test, developed under initial NIH support, through clinical trials and regulatory licensure. The trials will be carried out in collaboration with Blood Systems Research Institute of San Francisco, Calif., and Creative Testing Solutions of Tempe, Ariz. Creative Testing Solutions currently tests about 25% of the US blood supply, including regions endemic for the parasitic agent. The Babesia test will initially be made available through Creative Testing Solutions' laboratories.