TEST:

Helio Liver Test

P=N/A; Trial completion date: Dec 2022 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Mar 2024

"Helio Genomics said Thursday that its sister company, Laboratory for Advanced Medicine & Health Group (LAMH), has received approval from the National Medical Products Administration (NMPA) in China for its cell-free DNA-based liver cancer detection test. The assay is the first of its kind to receive this approval...The test is an adaptation of Helio's HelioLiver test that is specifically tailored for the genetic makeup of the Asia-Pacific population. The company estimated that 87 million people in China live with hepatitis B, a risk factor for liver cancer, representing one third of the hepatitis B population in the world."

Clinical trial information: NCT03694600. >

"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."

P=N/A; Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022

"Data from a recent clinical study presented at the ACMG Annual Clinical Genetics Conference, held March 22– 26, 2022 by the American College of Medical Genetics and Genomics, highlighted the performance of the HelioLiver Test. The results were published in Hepatology Communications."

"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."

"The specificities of the HelioLiver Test (91%; 95% CI, 85%-95%), AFP (97%; 95% CI, 92%-99%), and the GALAD score (94%; 95% CI, 88%-97%) were similar for control subjects. The HelioLiver Test showed superior performance for HCC detection compared to with both AFP and the GALAD score and warrants further evaluation in HCC surveillance settings."

"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."

P=N/A; N=500 --> 290

"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."

The performance of the multi-analyte HelioLiver Test was superior to both the GALAD model and AFP test alone, particularly for the early detection of HCC. By allowing the detection of HCC at an earlier stage where curative treatment is more likely, the morbidity and mortality induced by HCC is predicted to be reduced through application of such a test.

P=N/A; N=500; Completed; Sponsor:Laboratory for Advanced Medicine, Indiana

P=N/A; N=1000; Enrolling by invitation; Sponsor:Laboratory for Advanced Medicine, Indiana