FDA Clears Exact Sciences' Next-Generation Colorectal Cancer Diagnostic Test
FDA Clears Exact Sciences' Next-Generation Colorectal Cancer Diagnostic Test
Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.On Friday, the FDA approved Exact Sciences Corp.'s (NASDAQ:EXAS) Cologuard Plus test, the company's next-generation multi-target stool DNA test.
上周五，美国食品药品监督管理局批准了Exact Sciences Corp.（纳斯达克：EXAS）的Cologuard Plus检测，这是该公司的下一代多靶点粪便DNA检测。
The Cologuard Plus test is now approved for adults ages 45 and older who are at average risk for colorectal cancer (CRC).
Cologuard Plus检测现已获得批准，适用于45岁及以上年龄的普通风险结肠直肠癌（CRC）成人。
FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening.
FDA的批准基于蓝色C（BLUE-C）关键研究的结果，这是迄今为止在CRC筛查领域进行的最大规模前瞻性、头对头研究之一。
Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.
在近19000名普通风险参与者子集中，Cologuard Plus检测表现出95%的整体癌症敏感度，以94%的特异性检出43%的早期前癌病变。在结肠镜检查结果为阴性的情况下。
Results from BLUE-C also show the Cologuard Plus test significantly outperformed an independent fecal immunochemical test for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.
BLUE-C研究结果还显示，Cologuard Plus检测在整体CRC敏感度、可治疗阶段CRC（I-III期）敏感度、高级别异型增生敏感度和早期前癌病变敏感度方面明显优于独立的粪便免疫化学检测。
The Cologuard Plus test will build on the Cologuard test, which has been used more than 17 million times.
Cologuard Plus检测将构建在Cologuard检测的基础上，后者已经被使用超过1700万次。
The Cologuard test is a first-line colorectal cancer screening test for adults age 45 or older at average risk for the disease.
Cologuard检测是针对45岁以上普通风险患者的第一线结肠直肠癌筛查检测。
Upon launch in 2025, the Cologuard Plus test will be supported by Exact Sciences' commercial organization ExactNexus technology platform for orders from over 350 health systems.
2025年推出后，Cologuard Plus检测将得到Exact Sciences商业组织ExactNexus技术平台的支持，订单来自350多个卫生系统。
The non-invasive test is anticipated to be covered by Medicare.
非侵入性测试预计将由Medicare支付。
The Cologuard Plus test demonstrates 91% specificity, including non-advanced findings, 93% specificity, including no findings, and 94% specificity when age-weighted to the U.S. population with no findings on colonoscopy.
Cologuard Plus测试表现出91%的特异性，包括无进展性发现，93%的特异性，包括无发现，以及94%的特异性，当按照无结肠镜检查发现的美国人口的年龄加权计算。
In July this year, the FDA approved Guardant Health Inc.'s (NASDAQ:GH) Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease.
今年7月，FDA批准了纳斯达克上市公司Guardant Health Inc.的Shield血液测试，用于开展45岁及以上无风险人群的结肠癌（CRC）筛查。
The company says it is the first blood test approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield like all other non-invasive methods recommended in screening guidelines.
该公司表示，Shield是FDA批准的第一种原发筛查CRC的血液检测产品，意味着医疗保健提供者可以像使用所有其他非侵入性筛查方法一样提供Shield。
Price Action: EXAS stock is up 1.94% at $67.70 at the last check on Friday.
股价走势：EXAS股票在上周五最后一次交易时上涨1.94%，报67.70美元。
- Bristol Myers' $10B Cancer Drug Opdivo Scores Expanded Use FDA Approval For Lung Cancer In Pre And Post-Surgery Setting.
- 百时美施贵宝的100亿美元癌症药物Opdivo获得了FDA批准，在肺癌的术前和术后设定中扩大了使用。
