Three-Test Panel Launched for Detection of Liver Fluke Infections

Chronic infection is a well-established risk factor for cholangiocarcinoma, a rare but highly aggressive bile duct cancer, highlighting the need for accurate, targeted diagnostics. A newly launched three-test panel addresses this gap by enabling serologic detection of the major human liver fluke species.

Kephera Diagnostics (Framingham, MA, USA) has announced the introduction of the first commercial testing panel for liver fluke infections in the United States, offered through its CLIA-certified laboratory. The panel includes assays for Clonorchis sinensis (Chinese liver fluke), Opisthorchis viverrini (Southeast Asian liver fluke), and Fasciola hepatica (common liver fluke). The company previously received USD 2.3 million in Small Business Innovation Research (SBIR) funding from the National Institutes of Health to support development of the assays.

The panel detects antibodies to parasite-specific biomarkers using an enzyme-linked immunosorbent assay (ELISA) format. As a serological approach, it can identify evidence of both current and past infections. The offering is positioned as unique in the United States, with no tests for Clonorchis or Opisthorchis liver fluke infection currently available from the U.S. Centers for Disease Control and Prevention or other laboratories.

Infection with Chinese and Southeast Asian liver flukes is endemic across large regions of Asia, with estimates of up to 45 million people infected. Long-term infection with these species has been associated with cholangiocarcinoma and they are among the few parasites designated biological carcinogens by the World Health Organization. Fasciola hepatica is transmitted via aquatic plants such as watercress and is found worldwide, with between 2.4 million and 17 million people thought to be infected, particularly where sheep and cattle are raised.

“The launch of the liver fluke panel from our CLIA laboratory is a significant step forwards for public health as well as for Kephera,” said Andrew Levin, PhD, Chief Executive and Scientific Officer of Kephera Diagnostics. “It fills a known gap in diagnostics for these parasites, which have been underrecognized sources of illness due to the lack of available testing resources up until now.”.

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