Helio Health Announces Publication of ENCORE Data in Hepatology Communications Demonstrating Superior Performance of HelioLiver for Early Detection of Liver Cancer

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HelioLiver significantly outperforms other clinically available tools in the early and comprehensive detection of HCC

HelioLiver’s algorithm includes 77 DNA methylation targets in 28 genes, in addition to three protein markers

IRVINE, Calif., March 7, 2022 /PRNewswire/ — Helio Health (“Helio”), an AI-driven healthcare company focused on commercializing tests for the early detection of cancer from a simple blood draw, announced today today that Communications Hepatology published positive results from the ENCORE study validating the strong clinical performance of HelioLiver in detecting the presence of early hepatocellular carcinoma (HCC), the most common form of liver cancer and the seventh most common cancer in the world. world but the second in terms of cancer-related mortality, often due to late diagnosis.1 In this prospective, blinded, multicenter phase 2 study, HelioLiver demonstrated high specificity (91%) and high sensitivity (76%) in detecting HCC at an early stage (stage I and II), significantly outperforming significantly the other detection tools available in clinics such as AFP (57%), GALAD (65%) and ultrasound (47%).2.3 When considering HCC as a whole, HelioLiver performed at 85% sensitivity with the same 91% specificity.2

Helio Health

Diagnostic tests for HCC

Early Stage Susceptibility (I + II)

Overall Sensitivity

HelioLiver2

76%

85%

PFA (≥ 20 ng/mL)2

57%

62%

GALAD score (≥ -0.63)2

65%

75%

Ultrasound3

47%

84%

Note: Table shows HelioLiver sensitivities at 91% specificity2

2 Lin N, et al. 2021.

3 Tzartzeva K, et al. 2018.

Helio has developed its next-generation sequencing platform, ECLIPSEMT, to identify 77 methylation targets across 28 genes. These DNA markers work in combination with serum HCC proteins AFP, AFP-L3% and DCP to enhance the multi-analyte algorithm.

  • The area under receiver operating characteristic (AUROC) for HelioLiver was 0.944, demonstrating significantly better predictive ability than the other tests.

  • At a fixed specificity of 87.5%, HelioLiver achieved 87% sensitivity for early-stage HCC and 90% overall sensitivity.

  • 10 of the 28 genes used in the HelioLiver assay were found to be directly involved in molecular pathways known to be involved in the pathogenesis of HCC, while only one of the 497 genes studied but not selected met the same criteria, suggesting that the markers in HelioLiver are more biologically relevant than tests that use these other genes.

Communications Hepatology is the official open-access, peer-reviewed journal of the American Association for the Study of Liver Diseases (AASLD), dedicated to the rapid dissemination of high-quality research in hepatology. AASLD is the most respected medical guidelines organization for liver disease in United States.

“We are very pleased with the results of these trials. The population at high risk for liver cancer is in great need of a more efficient and less operator-dependent test to improve patient outcomes,” said Dr. Mindie Nguyenqualified hepatologist at Stanford University Medical Center and co-author of the article. “Blood tests can be more accessible and convenient because they can be done at the same visit as a consultation and at the same blood draw for other routine care, driving compliance rates higher.”

“The acceptance of our study results in this peer-reviewed journal represents external validation of the significant value HelioLiver brings to patients at high risk of liver cancer,” said Justin Chen LiChief Executive Officer, Helio Health. “The ENCORE study builds on years of research by our team and collaborators, who can now be very proud that their work is improving patient outcomes in the clinic.”

“Helio Health is an early pioneer in using cDNA methylation for cancer detection,” said Dr. David Taggartscientific director, Helio Health. “These ENCORE findings clearly demonstrate the value of the ECLIPSE platform for capturing informative methylation signals from cfDNA, as well as Helio’s superior bioinformatics capabilities for making sense of these signals. We look forward to leveraging this platform to advance our pipeline into other disease areas. such as colon, lung and breast cancer.”

HelioLiver is being further evaluated in Helio’s prospective pivotal biomarker study, CLiMB (NCT03694600), where test performance will be directly compared to ultrasound using multiphasic MRI as the standard of care for the diagnosis of HCC.

About ENCORE
The ENCORE study (NCT05059665) was a blinded multicenter validation study using blood samples collected from 247 participants, including 122 participants diagnosed with HCC and 125 control participants diagnosed with benign liver disease.

About HelioLiver
HelioLiver is a multi-analyte blood test that integrates cell-free DNA (cfDNA) methylation patterns, serum protein markers and demographic information for the detection of hepatocellular carcinoma (HCC), the most common form of breast cancer. liver.

“This recognition from Helio’s ENCORE study further validates HelioLiver’s performance in the early detection of liver cancer,” said Brandon Perthuis, Chief Commercial Officer, Fulgent Genetics. “We hope to continue to improve the standard of care for patients at high risk for hepatocellular carcinoma by increasing the availability of HelioLiver.”

Fulgent Genetics (NASDAQ: FLGT) is Helio Health’s exclusive commercial distribution partner for HelioLiver, which is currently available to order as a laboratory-developed test in United States and Canada.

Healthcare providers can place orders online at HelioLiver.com/how-to-order, by phone (+1 626-350-0537) or by email at [email protected] to connect with a representing.

For more information on HelioLiver and its clinical performance, please visit www.HelioLiver.com.

About the Helio ECLIPSE NGS Platform
ECLIPSE owner of HelioThe platform analyzes cfDNA using a targeted next-generation sequencing (NGS) approach to identify DNA methylation patterns associated with specific cancers. DNA methylation plays a key role in many biological processes and aberrant DNA methylation often occurs very early in cancer progression.

About Helio Health
Helio Health is an AI-driven healthcare company focused on bringing to market early detection tests for cancer from a simple blood draw. The company’s mission is to simplify cancer screening in order to save lives by detecting cancer earlier. With Helio’s AI-powered technology, doctors and their patients gain powerful insights through accurate, accessible, and convenient blood testing. Helio’s development program is focused on liver, colon, breast and lung cancers.

Helio Health is headquartered in Irvine, Californiawith R&D, GMP and CLIA facilities at Irvine, California and West Lafayette, IN.

Media
Melissa Roy
ICR Westwicke
[email protected]
(203) 682-8285

1 Fitzmaurice C, Abate D, Abbasi N, et al. Global, regional and national cancer incidence, mortality, years of life lost, years lived with disability and disability-adjusted life years for 29 cancer groups, from 1990 to 2017. JAMA Oncol. 2019;5(12):1749-1769. doi:10.1001/jamaoncol.2019.2996
2 Lin N, Lin Y, Xu J, et al. A multi-analyte blood test for accurate and early detection of hepatocellular carcinoma. Poster presented at: American Association for the Study of Liver Diseases – The Liver Meeting; November 12-15, 2021; Virtual.
3 Tzartzeva K, Obi J, Rich NE, et al. Surveillance imaging and alpha-fetoprotein for the early detection of hepatocellular carcinoma in patients with cirrhosis: a meta-analysis. Gastroenterology. 2018;154(6):1706-1718.e1. doi:10.1053/j.gastro.2018.01.064

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