“作为全球增长最快和最致命的癌症之一，必须尽早发现肝癌以启动治疗干预以优化成功的患者结果，”NCI 指定的 Chao 主任 Richard A. Van Etten 博士说家庭综合癌症中心和加州大学欧文分校血液学/肿瘤学部成员。 “这些结果表明 HelioLiver 有望重新定义护理标准，为患者和医疗保健提供者提供高度敏感、易于使用的血液检测。”
“经过严格的科学评估，这些新发现强调了 HelioLiver 在早期发现肝癌并最终挽救生命的潜力，”Helio Health 美国首席执行官 Justin Chen Li 说。 “通过我们与 Fulgent Genetics 的合作伙伴关系，我们期待在不久的将来从美国的 HelioLiver 开始提供新的早期癌症诊断技术。”
Helio Health and Fulgent Genetics Announce Late-Breaking Positive Performance Data of HelioLiver™ for Early Liver Cancer Detection
Data from the ENCORE study to be presented at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD)
News provided by
Helio Health and Fulgent Genetics, Inc.
Nov 08, 2021, 08:00 ET
IRVINE, Calif. and TEMPLE CITY, Calif., Nov. 8, 2021 /PRNewswire/ -- Helio Health ("Helio") and its commercial partner, Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent") today announced new data at AASLD demonstrating the performance of HelioLiver in detecting early hepatocellular carcinoma (HCC). At 91% specificity, the sensitivity of HelioLiver was 76% in early-stage HCC and 85% in overall HCC1, demonstrating superior performance over alpha fetoprotein (AFP) alone and the GALAD model.
Early Stage (I + II) Sensitivity Overall Sensitivity
HelioLiver1 76% 85%
AFP (≥ 20 ng/mL)1 57% 62%
GALAD Score (≥ -0.63)1 65% 75%
Ultrasound2 47% 84%
Note: Table denotes HelioLiver sensitivities at 91% specificity1
HelioLiver is a multi-analyte blood test that utilizes both cell-free DNA (cfDNA) methylation patterns and protein tumor markers to detect early-stage HCC with high accuracy. HelioLiver has the potential to reduce morbidity and mortality in HCC patients as there are more curative treatment options when the cancer is found at earlier stages. A highly sensitive blood test can drive patient adherence to surveillance guidelines and provide a more convenient and cost-effective way to detect HCC.
"As one of the fastest growing and deadliest cancers worldwide, it is essential to detect liver cancer as early as possible to initiate treatment intervention to optimize successful patient outcomes," said Dr. Richard A. Van Etten, Director of the NCI-designated Chao Family Comprehensive Cancer Center and member of the Division of Hematology/Oncology at the University of California, Irvine. "These results indicate HelioLiver has significant promise to redefine the standard of care in terms of providing a highly sensitive, easy-to-use blood test for patients and healthcare providers alike."
"As a result of rigorous scientific evaluations, these new findings underscore HelioLiver's potential to detect liver cancer early and ultimately save lives," said Justin Chen Li, U.S. Chief Executive Officer, Helio Health. "Through our partnership with Fulgent Genetics, we look forward to delivering new early cancer diagnostic technologies beginning with HelioLiver in the U.S. in the near future."
The ENCORE study was a blinded, multicenter validation study using blood specimens drawn from 303 subjects. The study included 122 subjects diagnosed with HCC, 125 control subjects diagnosed with a benign liver disease, and 56 subjects diagnosed with other cancer types.
The poster presentation, titled "A Multi-Analyte Blood Test for Accurate and Early Detection of Hepatocellular Carcinoma," will be available for viewing by the attendees of The Liver Meeting® beginning November 8, 2021.
The HelioLiver test continues to be evaluated in Helio's pivotal prospective study, CLiMB (NCT: 03694600)