NEW YORK – Kephera Diagnostics announced on Monday that it has received a $3.0 million Phase II SBIR grant from the National Institutes of Health's National Institute of Allergy and Infectious Diseases to develop and clinically validate a point-of-care neurocysticercosis test.
Neurocysticercosis is an infection of the central nervous system with the cystic form of the tapeworm Taenia solium that can cause seizures and become fatal if left untreated. Kephera's test is intended to discriminate neurocysticercosis from other causes of seizures in patients presenting with epileptic-like symptoms, the company said in a statement.
The grant follows a previous $600,000 Phase I SBIR grant awarded to the firm in 2020 to prove the feasibility of its test.
The funding will be used to complete development of the lateral flow assay, which detects antibodies to a combination of parasite-specific antigens in a finger-prick blood sample. The antigens are derived from the US Centers for Disease Control and Prevention's enzyme immunotransfer blot test, the gold standard for neurocysticercosis diagnosis, Kephera said.
The Framingham, Massachusetts-based company also plans to carry out a multicenter clinical study of the rapid test's performance to support approval from the US Food and Drug Administration.
The grant "confirms the validity of our methodology and approach and will enable us to advance the test through clinical trials and to make it available commercially, where we believe it will fill an important gap in the diagnosis and treatment of patients presenting with seizures worldwide," Kephera CEO Andrew Levin said in a statement.
In March, the company received a $3.0 million grant from the NIH to finish developing a point-of-care test for Chagas disease, and a separate $600,000 grant to develop an antibody-based test for hookworm infection.