Framingham, MA – February 10, 2026.  Kephera Diagnostics has launched the first commercial testing panel for liver fluke infection, offered through its CLIA laboratory, the Company announced today. The panel includes tests for three liver fluke species, Clonorchis sinensis (Chinese liver fluke), Opisthorchis viverrini (Southeast Asian liver fluke) and Fasciola hepatica (Common liver fluke).  Kephera had previously received $2.3 million in funding under SBIR contracts from the National Institutes of Health to support the development of these tests.

Human infection with Chinese and Southeast Asian liver flukes is 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 infected1.   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 these liver fluke species 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.  A 2018 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 South Korea2.  The U.S. Dept. of Veterans Affairs has raised questions about the validity of that study and was planning to investigate the frequency of cholangiocarcinoma among veterans according to information posted on its website3.

Fasciola hepatica liver flukes are transmitted to humans through eating aquatic plants that carry the larval cysts of the parasite, typically watercress.  Fasciola is found worldwide, with between 2.4 and 17 million people thought to be infected, with higher prevalence in areas where sheep and cattle are raised4.  Fasciola infection initially affects the liver and if untreated, can cause chronic inflammation and blockage of the bile ducts, gallbladder, pancreas or other tissues, potentially leading to fibrosis.

Kephera’s liver fluke panel detects antibodies to specific parasite biomarkers using an ELISA format.  The panel is unique as no tests for Clonorchis or Opisthorchis liver fluke infection are currently available from the CDC or other laboratories in the United States.  As a serological test, the panel can detect evidence of both current and past infections.   Further information and instructions for submitting samples for testing can be found on Kephera’s website, https://kephera.com.

“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 Dr. Andrew Levin, 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”.

Development of the tests by Kephera was funded by the National Cancer Institute, National Institutes of Health, under SBIR Contract No. 75N91021C00047.  Kephera collaborated with the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok, Thailand, the U.S. Centers for Disease Control and the National Institute of Malariology, Parasitology and Entomology in Hanoi, Vietnam to develop the panel.

About Kephera Diagnostics

Kephera Diagnostics is a CLIA-certified and CAP-accredited diagnostic laboratory delivering excellence in specialized diagnostics. We focus on diagnostic solutions for diseases where there are significant gaps in addressing patient needs, particularly in underserved areas of healthcare including infectious diseases and women’s health. Our mission is to promote more effective and affordable medical treatment through faster diagnosis.  We collaborate with a global community of researchers and clinicians to develop and translate new technologies into accessible products for clinical diagnostics and research applications. 

Contact:
Andrew Levin, PhD
Chief Executive Officer
617-834-0950 cell
alevin@kephera.com
www.kephera.com

Citations

  1. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Biological Agents. Lyon (FR): International Agency for Research on Cancer; 2012. (IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, No. 100B.) OPISTHORCHIS VIVERRINI AND CLONORCHIS SINENSIS. Available from: https://www.ncbi.nlm.nih.gov/books/NBK304354/
  2. Psevdos G, Ford FM, Hong ST. Screening US Vietnam Veterans for Liver Fluke Exposure 5 Decades After the End of the War. Infect Dis Clin Pract (Baltim Md). 2018 Jul;26(4):208-210. doi: 10.1097/IPC.0000000000000611. Epub 2018 Jan 16. PMID: 30034207; PMCID: PMC6039373.
  3. https://www.publichealth.va.gov/exposures/publications/agent-orange/agent-orange-2021/bile-duct-cancer.asp
  4. Lan Z, Zhang XH, Xing JL, Zhang AH, Wang HR, Zhang XC, Gao JF, Wang CR. Global prevalence of liver disease in human and domestic animals caused by Fasciola: A systematic review and meta-analysis. J Glob Health. 2024 Sep 19;14:04223. doi: 10.7189/jogh.14.04223. PMID: 39297588; PMCID: PMC11412093.