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.
上週五，美國食品藥品監督管理局批准了Exact Sciences Corp.（納斯達克：EXAS）的Cologuard Plus檢測，這是該公司的下一代多靶點糞便DNA檢測。
The Cologuard Plus test is now approved for adults ages 45 and older who are at average risk for colorectal cancer (CRC).
Cologuard Plus檢測現已獲得批准，適用於45歲及以上年齡的普通風險結腸直腸癌（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的批准基於藍色C（BLUE-C）關鍵研究的結果，這是迄今爲止在CRC篩查領域進行的最大規模前瞻性、頭對頭研究之一。
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名普通風險參與者子集中，Cologuard Plus檢測表現出95%的整體癌症敏感度，以94%的特異性檢出43%的早期前癌病變。在結腸鏡檢查結果爲陰性的情況下。
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研究結果還顯示，Cologuard Plus檢測在整體CRC敏感度、可治療階段CRC（I-III期）敏感度、高級別異型增生敏感度和早期前癌病變敏感度方面明顯優於獨立的糞便免疫化學檢測。
The Cologuard Plus test will build on the Cologuard test, which has been used more than 17 million times.
Cologuard Plus檢測將構建在Cologuard檢測的基礎上，後者已經被使用超過1700萬次。
The Cologuard test is a first-line colorectal cancer screening test for adults age 45 or older at average risk for the disease.
Cologuard檢測是針對45歲以上普通風險患者的第一線結腸直腸癌篩查檢測。
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年推出後，Cologuard Plus檢測將得到Exact Sciences商業組織ExactNexus技術平台的支持，訂單來自350多個衛生系統。
The non-invasive test is anticipated to be covered by Medicare.
非侵入性測試預計將由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測試表現出91%的特異性，包括無進展性發現，93%的特異性，包括無發現，以及94%的特異性，當按照無結腸鏡檢查發現的美國人口的年齡加權計算。
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批准了納斯達克上市公司Guardant Health Inc.的Shield血液測試，用於開展45歲及以上無風險人群的結腸癌（CRC）篩查。
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.
該公司表示，Shield是FDA批准的第一種原發篩查CRC的血液檢測產品，意味着醫療保健提供者可以像使用所有其他非侵入性篩查方法一樣提供Shield。
Price Action: EXAS stock is up 1.94% at $67.70 at the last check on Friday.
股價走勢：EXAS股票在上週五最後一次交易時上漲1.94%，報67.70美元。
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譯文內容由第三人軟體翻譯。
