The National Cancer Institute, an agency of the National Institutes of Health, has awarded a Phase I Small Business Innovative Research (SBIR) contract to Kephera Diagnostics (Framingham, MA) for $299,997 to develop a test for liver fluke infection, the company announced today. The Phase I contract will enable the company to develop a prototype of the test and to evaluate its performance on patients who have been infected with this parasite. Successful results from this evaluation could lead to further SBIR funding for product development and clinical trials.
Liver flukes are acquired by eating raw freshwater fish that are infected with the parasites. They are endemic in large parts of Asia, including China, Korea and Southeast Asia, with estimates of up to 45 million people infected. The parasites live in the bile ducts and can apparently survive for decades, with symptoms ranging from mild to severe depending on parasite burden and duration of infection. Infection can be treated effectively by relatively inexpensive and accessible drugs. However, long-term infection with liver flukes has been linked to cholangiocarcinoma, a relatively uncommon but highly lethal cancer which may occur years later. Accordingly, several liver fluke species have been designated as biological carcinogens by the World Health Organization.
Liver fluke infection has been raised as a possible risk factor for cholangiocarcinoma in U.S. personnel who served in Vietnam during the war between 1961-1975. A 2018 study found evidence of an elevated rate of exposure to the parasites in a group of Vietnam veterans, based on the detection of an immune response to parasite antigens. The test used in that study is not available in the U.S., however.
The NCI contract will support Kephera’s efforts to develop a test for liver fluke infection which could ultimately be used to screen Vietnam veterans as well as others who may be at risk for infection based on potential exposure in endemic countries. The test, which will rely on parasite-derived immunological markers, will be developed in both laboratory-based and point-of-care formats to enable testing in a variety of settings, including endemic regions where few laboratory facilities are available. Kephera scientists are planning to work with collaborators in public health and research agencies in Vietnam, who will provide samples to aid in development of the test, which will be carried out in Kephera’s laboratory in the U.S.
“We look forward to the challenge of developing a rapid and accurate test for liver fluke infection” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the contract. “There is a clear need for such a test, based on the clinical and economic impact of infection worldwide, and this project is directly in line with Kephera’s mission to address emerging and neglected infectious diseases with new and accessible diagnostics.”
The contract awarded to Kephera Diagnostics is NIH Award No. 75N91019C00048.