Fulgent Genetics, a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, and Helio Health (“Helio”), an AI-biotechnology company developing blood-based early cancer detection tests, announced the companies have entered into a strategic partnership to commercialize Helio’s blood-based early cancer detection tests. In conjunction with the commercial strategic partnership whereby the company has secured exclusive commercial rights for laboratory-developed tests (“LDTs”) in the U.S. and Canada, Fulgent has made a strategic investment in Helio.

Under this partnership, the companies will initially commercialize and co-brand HelioLiver, a cell-free DNA (cfDNA) methylation blood test that incorporates protein markers and demographics for the detection of hepatocellular carcinoma (HCC) – or liver cancer. HelioLiver is currently undergoing clinical trials in the U.S. and China. Fulgent will be responsible for laboratory operations, supply chain operations, and marketing and sales leveraging its operational excellence and significant market reach initially focused in the U.S. and Canada. Helio will provide intellectual property and continued support across research and development, publication development, market access and sales, as well as reimbursement operations. Fulgent and Helio will also work together on the development of additional liquid biopsy tests for different types of cancer in the future.

Helio’s new approach to detecting cancer with cfDNA methylation technology has the potential to provide a paradigm shift in the way the disease is diagnosed and monitored. The companies expect to launch HelioLiver this calendar year.

“We are very excited to partner with Helio to offer Helio's liquid biopsy test for early cancer detection,” said Dr. Larry Weiss, Chief Medical Officer at Fulgent. “Helio has demonstrated that its liquid biopsy test offers significantly better accuracy relative to other test methods for early cancer detection. Helio’s methylation-based capabilities will supplement Fulgent’s comprehensive test menu across oncology, infectious and rare diseases, and reproductive health.”

"We are pleased to be working with Helio on the development and commercialization of its liquid biopsy testing capabilities,” said Dr. Harry Gao, Chief Scientific Officer at Fulgent. “In addition to testing for liver cancer, Fulgent and Helio will work to develop early screening for other types of cancers using Helio’s methylation-based technologies. This research and development opportunity will further expand Fulgent’s capabilities in liquid biopsy and oncology testing.”

“Partnering with Fulgent furthers our mission to save lives by dramatically improving the current standard of care methods of early cancer detection,” said Justin Chen Li, CEO of Helio USA. “Fulgent’s strong commercial capabilities will enable us to solidify quick adoption of the HelioLiver test in the U.S. and Canada, with the option to expand globally