COMPANY:

Helio Genomics

"Helio Genomics ("Helio"), and its commercial partner, Fulgent Genetics (NASDAQ: FLGT) ("Fulgent") announced that the American Medical Association (AMA) has issued a new Category I Current Procedural Terminology (CPT®) Proprietary Laboratory Analyses code for HelioLiver™, enabling a reimbursement pathway for potential increased access and broader adoption of innovative surveillance tests for liver cancer in the U.S. The code will become effective on October 1, 2022."

"Helio Health ("Helio")...today announced that Hepatology Communications published positive results from the ENCORE study validating HelioLiver's strong clinical performance in detecting the presence of early hepatocellular carcinoma (HCC), the most common form of liver cancer and the seventh most common cancer worldwide but the second in cancer-related mortality, often due to late diagnosis."

"Helio Health...and its commercial partner, Fulgent Genetics, Inc...today announced the commercial launch of HelioLiver™, a multi-analyte blood test that incorporates cell free DNA (cfDNA) methylation patterns and serum protein markers for the detection of hepatocellular carcinoma (HCC) – the most common form of liver cancer. HelioLiver can detect HCC at its earliest stages when lesions are still very small, an area where traditional standard-of-care imaging tools often fall short, with the potential to enable more curative treatment options known to increase five-year survival rates by up to 13 times compared to when cancer has metastasized."

"Helio Health...and Fulgent Genetics, Inc...announced its upcoming late-breaking poster presentation on the performance of HelioLiver, a multi-analyte blood test that utilizes both cell-free DNA (cfDNA) methylation patterns and protein tumor markers for the detection of hepatocellular carcinoma (HCC), at The Liver Meeting® 2021. The annual meeting is hosted by the American Association for the Study of Liver Diseases (AASLD) and will be held virtually November 12-15, 2021."

"Fulgent Genetics, Inc...and Helio Health...announced the companies have entered into a strategic partnership to commercialize Helio’s blood-based early cancer detection tests...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."

"FUJIFILM Medical Systems U.S.A., Inc...and Helio Health...today announced their collaboration to provide a blood-based assay that can help with the earlier detection of liver cancer. Through this relationship, Helio Health’s DNA methylation and biomarker-based blood test technology, recognized as the HelioLiver Test, will leverage Fujifilm’s 510(k)-cleared µTASWako® i30 Immunological test system for liver cancer biomarkers."

"Helio Health…today announced that it was awarded a grant in partnership with the National Cancer Center (NCC) from the Ministry of Science and Technology of China, which will enable accelerated development of its Helio Liver Test, the Company’s first blood test designed for the early detection of HCC or liver cancer."