NEW YORK (360Dx) — Kephera Diagnostics announced today that it has received a $599,316 grant from the National Institutes of Health to demonstrate the feasibility of an investigational point-of-care test for Chagas disease.
Chagas disease is caused by the parasite Trypanosoma cruzi and, if left untreated, can cause cardiac and intestinal complications including fatal cardiomyopathy. Transmitted by insects only found in the Americas, T. cruzi infection affects an estimated 8 million people in Mexico, Central America, and South America.
Kephera's test is based on trypanosomal excreted/secreted antigen (TESA), a semi-purified native protein preparation from cultured T. cruzi, and uses a proprietary purification procedure that enriches and concentrates the antigenic component of TESA to make it suitable for use in a lateral flow assay format.
Kephera said in the grant's abstract that it has already created a prototype assay with greater analytical sensitivity than existing Chagas tests. The prototype also has broad detection of T. cruzi infections across Latin America.
Framingham, Massachusetts-based Kephera said it will use the two-year Phase I Small Business Innovation Research grant to develop and demonstrate a complete, portable TESA-based lateral flow assay suitable capable of producing results within 15 minutes in either a field or clinical setting.
Pending positive results, the company said it will apply for a Phase II SBIR grant to support the regulatory approval and commercial launch of the test.