Immunetics, Inc. today announced it has been awarded a $2.4 million, 3-year Phase II SBIR grant by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health (NIH), to support clinical trials of the company's new confirmatory test for Chagas' disease, a serious and potentially fatal parasitic infection.
Chagas' disease is endemic in large parts of Latin America, where it affects up to 11 million people, and has emerged in the U.S., where more than 300,000 people are infected, according to the Centers for Disease Control and Prevention. The disease is difficult to diagnose, and is often silent for years before clinical symptoms appear. During this time, carriers can pass on the parasite through blood donations and infect transfusion recipients.
Existing screening tests that detect antibodies to the parasite are frequently inaccurate. A complex method called radioimmunoprecipitation (RIPA) is sometimes used to confirm screening test results, but is beyond the reach of most laboratories. There are no FDA-approved confirmatory test methods.
Immunetics' test, called an immunoblot, detects antibodies to the parasite and is based on the same technology used in confirmatory tests for HIV and several other bloodborne infections. Data presented by Immunetics at meetings in 2010 of the American Association of Blood Banks and the American Society of Tropical Medicine and Hygiene showed the immunoblot test to be as accurate as RIPA in preliminary studies, said Dr. Andrew Levin, president and scientific director, Immunetics.
"The new NIH grant will enable Immunetics to undertake a full-scale clinical trial to obtain data to submit to the FDA for approval of the immunoblot as a confirmatory test. Immunetics will undertake the studies with collaborators at Blood Systems Research Institute, the American Red Cross, and the Centers for Disease Control and Prevention," Levin said.
"This grant award gives us the opportunity to take our Chagas' immunoblot test through the clinical studies needed to establish its validity as a confirmatory test. We are very grateful for NIH support for this project, which will allow us to bring forward a practical solution to one part of the growing public health and blood safety problem that Chagas' disease presents in the U.S. and Latin America," he said.
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