Exact Sciences提供基于血液的肝细胞癌检测数据，获得FDA突破性

StephenW

Exact Sciences Presents Data On Blood-Based Test For Detection Of Hepatocellular Carcinoma, Earns FDA Breakthrough Device Designation
[PR Newswire]
PR NewswireNovember 9, 2019

Data to be Presented at AASLD 2019, Abstract Selected for The Best of the Liver Meeting®

BOSTON, Nov. 8, 2019 /PRNewswire/ -- (EXAS) – A new study of 443 patients by Exact Sciences Corp. and its collaborators demonstrated 80% sensitivity at 90% specificity with a novel combination of six blood-based biomarkers for the most common type of liver cancer, hepatocellular carcinoma (HCC)i. The study also showed 71% sensitivity for early stage HCC at 90% specificity. The study compared performance to the alpha-fetoprotein (AFP) test, which demonstrated 45% sensitivity at 90% specificity for early stage HCC. Lead author Naga Chalasani, M.D., Associate Dean for Clinical Research at Indiana University School of Medicine and Director, Division of Gastroenterology and Hepatology, will present the findings Sunday, November 10th at the 2019 annual meeting for the American Association for the Study of Liver Diseases (AASLD) in Boston.
Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)
Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

The data are included by AASLD's Scientific Program Committee in The Best of The Liver Meeting, a distinction that recognizes abstracts for their rigorous scientific methodology and key insights for patient care and ongoing research. Exact Sciences' HCC test has also been granted Breakthrough Device designation by the U.S. Food and Drug Administration. The agency's Breakthrough Devices program expedites development, assessment, and review processes to provide patients and health care providers with timely access to new technologies.

Liver cancer is the number four cancer killer globally, and more than 42,000 Americansii and 780,000 people worldwide are diagnosed with the disease each yeariii. HCC alone accounts for approximately 90% of primary liver cancersiv. Clinicians and patients need more accurate, convenient testing options to help combat rising incidence rates, which have more than tripled since 1980i.

Current guidelines recommend at-risk patients undergo testing every six months using ultrasound (US) with or without the AFP blood testv. Combined, US and AFP have demonstrated 63% sensitivity for early stage cancersvi. Nearly half of Medicare patients tested for HCC receive only the AFP testvii, which in Exact Sciences' Study was less sensitive for HCC detection than US and AFP combined. Three-year survival rates nearly double for patients who undergo regular testing compared to those who do not, yet fewer than one-third of patients adhere to current guidelinesv.

"A growing number of patients around the world are considered high risk for developing HCC," said Kevin Conroy, chairman and CEO of Exact Sciences. "A more sensitive and convenient blood-based test could help catch the disease earlier, which may lead to better outcomes. We are encouraged by the data presented at The Liver Meeting, as it shows an important advancement over the options currently available."

Exact Sciences' multi-center, case-control study analyzed 443 blood samples, including 135 HCC cases and 308 age- and liver disease etiology-matched controls. The accuracies of both Exact Sciences' HCC test and the AFP blood test were analyzed for all Barcelona Clinic Liver Cancer (BCLC) stages and for early stage HCC (stages 0 and A). With specificity set at 90%, Exact Sciences' four methylated DNA markers and two protein markers detected 80% of HCC cases across all stages. The test demonstrated 71% sensitivity for early stage HCC, outperforming the AFP test, which detected 45% of early stage cancers and 62% of cancers across all stages in Exact Sciences' study.

"There is a significant, worldwide unmet need for a blood-based, early detection diagnostic test for liver cancer in persons with elevated risk for the disease," said Dr. Chalasani. "The DNA methylation based liquid biopsy developed by Exact Sciences is timely and very promising for addressing this unmet demand."

Exact Sciences is finalizing its HCC test development and plans to make the test available in the second half of 2020. This will help generate real-world evidence to support guideline inclusion, broad reimbursement, and adoption of the test over time.

Note to editors: The full abstract (#109) can be found in the October 2019 supplement of Hepatology.   

StephenW

Exact Sciences提供基于血液的肝细胞癌检测数据，获得FDA突破性设备称号
[美通社]
美通社（亚洲）2019年11月9日

数据将在AASLD 2019上发表，摘要被选为The Best of the LiverMeeting®

波士顿，2019年11月8日，美通社-PR Newswire /-（EXAS）– Exact Sciences Corp.及其合作者对443位患者进行的一项新研究显示，六种基于血液的生物标记物的新颖组合可实现80％的敏感性和90％的特异性。该研究还显示，对早期HCC的敏感性为71％，特异性为90％。这项研究将性能与甲胎蛋白（AFP）进行了比较，该试验证明了主要作者，印第安纳大学医学院临床研究副院长，胃肠病学和肝病学部主任Naga Chalasani医师将介绍该药物的敏感性。调查结果于11月10日星期日在美国美国肝病研究协会（AASLD）2019年年会上发表。
Exact Sciences Corporation徽标（PRNewsfoto / EXACT SCIENCE CORP）
Exact Sciences Corporation徽标（PRNewsfoto / EXACT SCIENCE CORP）

AASLD的科学计划委员会将这些数据包括在“肝病最佳会议”中，这一殊荣是对摘要的严格科学方法论以及对患者护理和正在进行的研究的重要见解的认可。 Exact Sciences的HCC测试还获得了美国食品和药物管理局的突破性设备称号。该机构的“突破性设备计划”加快了开发，评估和审查过程，为患者和医疗保健提供者及时获得了新技术。

肝癌是全球排名第四的癌症杀手，每年有超过42,000美国人ii和780,000人被诊断出患有该疾病iii。单纯HCC约占原发性肝癌的90％iv。临床医生和患者需要更准确，方便的测试方法来帮助应对不断上升的发病率，自1980i以来，发病率已增长了两倍多。

当前的指南建议高危患者每六个月接受超声检查（有或没有AFP血液测试）。美国和法新社联合证明对早期癌症的敏感性为63％vi。在接受HCC检测的Medicare患者中，几乎有一半仅接受AFP testvii，在Exact Sciences的研究中，该检测对HCC检测的敏感性低于美国和AFP的总和。经过常规检查的患者的三年生存率几乎是未接受常规检查的患者的两倍，但还不到少于三分之一的患者。

“越来越多的敏感和方便的基于血液的测试可以帮助更早发现疾病，从而可能导致更好的结果。肝脏会议上提供的数据使我们感到鼓舞，因为它显示了在当前可用选项方面的重要进展。”

Exact Sciences的多中心病例对照研究分析了443份血液样本，包括135例HCC病例和308例与年龄和肝脏疾病病因匹配的对照。对巴塞罗那临床肝癌（BCLC）的所有阶段和早期肝癌（0和A期）进行了Exact Sciences HCC检测和AFP血液检测的准确性分析。 Exact Sciences的四个甲基化DNA标记和两个蛋白质标记的特异性设定为90％，在所有阶段检测出80％的HCC病例。证据表明，对于早期HCC的敏感性为71％，胜过AFP测试，该实验在Exact Sciences的研究中检测到45％的早期癌症和62％的所有阶段的癌症。

Chalasani博士说：“在全球范围内，对于以血液为基础的肝癌早期检测诊断测试存在着巨大的需求缺口，该疾病对肝癌的高风险人群具有诊断作用。” “ Exact Sciences开发的基于DNA甲基化的液体活检技术是及时的，对于解决这一未满足的需求非常有希望。”

Exact Sciences正在完成其HCC测试的开发工作，并计划在2020年下半年提供该测试。这将有助于产生真实的证据，以支持指南的纳入，广泛的报销以及随着时间的推移而采用该测试。

编者注：完整摘要（＃109）可以在2019年10月《肝病学》增刊中找到。