NEW YORK — Kephera Diagnostics said on Friday that it has been awarded a $3 million grant from the National Institutes of Health to finish work on a point-of-care test for the parasitic infection Chagas disease.
Chagas disease is caused by the parasite Trypanosoma cruzi, which is transmitted by triatomine bugs. If left untreated, it can cause cardiac and intestinal complications including fatal cardiomyopathy.
Kephera's test is based on trypanosomal excreted/secreted antigens (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.
With the money from the Phase II Small Business Innovation Research grant, Kephera aims to complete development of the test and validate its performance in multicenter clinical studies in the US and Latin America. The work, being done in collaboration with researchers from Boston University/Boston Medical Center and Johns Hopkins University, will support commercialization of the test, Kephera said.
"Chagas disease is an under-recognized problem among Latin American migrants in the US and is an important neglected tropical disease in Mexico [and] Central and South America," Davidson Hamer, a Boston University collaborator on the grant, said in a statement. "Better diagnostic tools, especially at the point of care, are greatly needed to improve patient care."
In late 2018, Framingham, Massachusetts-based Kephera received a nearly $600,000 Phase I SBIR grant from the NIH for feasibility studies for the test.