Helio Health 和 Fulgent Genetics 宣布 HelioLiver™ 用于早期肝癌检测

StephenW

Helio Health 和 Fulgent Genetics 宣布 HelioLiver™ 用于早期肝癌检测的最新阳性性能数据

ENCORE 研究的数据将在由美国肝病研究协会 (AASLD) 主办的 The Liver Meeting® 2021 上公布

新闻由
Helio Health 和 Fulgent Genetics, Inc.

2021 年 11 月 8 日，美国东部时间 08:00

加利福尼亚州欧文市和加利福尼亚州坦普尔市，2021 年 11 月 8 日/美通社/ -- Helio Health（“Helio”）及其商业合作伙伴 Fulgent Genetics, Inc.（纳斯达克股票代码：FLGT）（“Fulgent”）今天宣布AASLD 的新数据证明了 HelioLiver 在检测早期肝细胞癌 (HCC) 方面的性能。在 91% 的特异性下，HelioLiver 在早期 HCC 中的敏感性为 76%，在整体 HCC1 中为 85%，表现出优于单独使用甲胎蛋白 (AFP) 和 GALAD 模型的性能。



                              早期 (I + II) 敏感性 总体敏感性

HelioLiver1 76% 85%

AFP (≥ 20 ng/mL)1 57% 62%

GALAD 分数 (≥ -0.63)1 65% 75%

超声波 2 47% 84%

注意：表中表示 HelioLiver 敏感性为 91% 特异性1

HelioLiver 是一种多分析物血液检测，利用无细胞 DNA (cfDNA) 甲基化模式和蛋白质肿瘤标志物来高精度检测早期 HCC。 HelioLiver 有可能降低 HCC 患者的发病率和死亡率，因为在早期发现癌症时有更多的治愈性治疗选择。高度敏感的血液检测可以促使患者遵守监测指南，并提供一种更方便、更经济的 HCC 检测方法。

“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。”

ENCORE 研究是一项盲法、多中心验证研究，使用来自 303 名受试者的血液样本。该研究包括 122 名被诊断患有 HCC 的受试者、125 名被诊断患有良性肝病的对照受试者和 56 名被诊断患有其他癌症类型的受试者。

从 2021 年 11 月 8 日开始，Liver Meeting® 的与会者可以观看题为“用于准确和早期检测肝细胞癌的多分析物血液检测”的海报展示。

HelioLiver 测试继续在 Helio 的关键前瞻性研究 CLiMB 中进行评估（NCT：03694600）

StephenW

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)

StephenW

https://www.prnewswire.com/news- ... tion-301418252.html