Framingham, MA – October 20, 2021. Kephera Diagnostics has been awarded a $1,999,961 million Phase II Small Business Innovative Research (SBIR) contract by the National Cancer Institute, an agency of the National Institutes of Health, for a test for liver fluke infection, the Company announced today. Kephera had previously received a $300,000 Phase I contract to develop and demonstrate the feasibility of its test.
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, cancer of the bile duct, a relatively uncommon but highly lethal cancer which may occur years later. For this reason, liver fluke is one of only two parasites that 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 between 1961-1975, who are estimated to number over 600,000 today. An earlier study found evidence of an elevated rate of exposure to the parasites in a group of Vietnam veterans, based on an antibody test carried out in Korea. Recent reports show a 6-fold increase in claims for bile duct cancer submitted to the Dept. of Veterans Affairs (VA) over the past two decades. Based on these findings, Sen. Chuck Schumer of New York has advocated for further investigation, and a bill (H.R. 1273) named the “Vietnam Veterans Liver Fluke Cancer Study Act” was introduced in Congress by Rep. Lee Zeldin of New York in 2021, where it is now under review by the House Veterans’ Affairs Committee. The house bill would require ongoing studies to determine the prevalence of liver fluke and cholangiocarcinoma in veterans.
The Phase II NCI contract will allow Kephera to complete development of its test for liver fluke infection, obtain regulatory approvals, and launch it through the Company’s CLIA laboratory for screening of veterans and others who may be at risk for infection based on having lived or travelled in endemic countries. The test, which will ultimately be offered in both laboratory and point-of-care formats, will detect antibodies to specific parasite markers. Kephera scientists will work with collaborators at the National Institute of Malaria, Parasitology and Entomology in Vietnam, the country’s leading institution for research on human pathogenic parasites, and the Hanoi University of Public Health.
“The award of this Phase II contract from NCI validates our work on development of the liver fluke test and is a major step forwards for Kephera Diagnostics, advancing our mission to improve diagnostics for people affected by emerging and neglected infectious diseases worldwide” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the contract. “We look forward to making the test available for the screening of U.S. veterans for liver fluke, as a tool to address this significant public health need”.
This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N91021C00047.
About Kephera Diagnostics
Kephera Diagnostics is a startup that aims to address the public health challenges of global infectious diseases with new point of care assay technology. Our mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis. We collaborate with a global community of researchers to develop and translate new technologies into accessible products for clinical diagnostics and research applications. Kephera has recently been funded for development of new tests for several infectious diseases of global significance.
Andrew Levin, PhD
Chief Executive Officer