FDA批准非侵入型大便DNA肠癌筛查试剂盒Cologuard

Exact科学公司8月12日宣布，FDA已批准非侵入型、大便DNA结直肠癌筛查试剂盒Cologuard。而在同一天，Exact公司也收到美国医疗保险和医疗补助服务中心（CMS）提议的医疗保险覆盖备忘录，提议将Cologuard进行全国医疗覆盖。

Cologuard是FDA批准的首个非侵入性结直肠癌筛查试剂盒，通过分析粪便DNA和血液生物标志物来筛查结直肠癌，该试剂盒已被证明能够在平均风险群体中发现92%的癌症和69%的晚期癌前息肉。Cologuard可通过医疗保健机构获取，为50岁及以上具有结直肠癌平均风险的群体提供一种易用的筛查试剂盒，使他们能够在家里开展，有助于保护其隐私权。

Cologuard是进入FDA和CMS联合平行审查试点项目的首个产品，该项目中，2个机构同时审查医疗器械，有助于缩短FDA批准和医疗保险覆盖之间的时间。在公众征询期结束后，最终全国覆盖意见预计将于今年10月/11月公布。

Cologuard被设计为从来自消化过程中结肠脱落的癌细胞和大便血液中的DNA来检测生物标志物。医师订购Cologuard后，直接将试剂盒邮寄至患者家中，然后患者利用Cologuard试剂盒中的大便采集盒采集粪便，再将试剂盒通过预付费邮差寄回Exact实验室进行检测。Cologuard在医疗保健提供商处的售价为599美元，患者寄回后可在2个星期内获得检测结果。

结直肠癌是一种高度可预防的癌症，通过推荐的筛查指南筛查，可在疾病早期阶段发现病情。约60%的结直肠癌病例在发现时已到晚期，使得治疗更加困难。因此，迫切需要一些新的、患者友好的筛查选择，以防止结直肠癌或在可治疗的早期阶段发现癌症。鉴于有超过半数的结直肠癌相关死亡可通过常规筛查避免，对结肠镜检查有抗拒情绪的患者群体，Cologuard作为另一种筛查选择，能够显著改善筛查的依从性，从而提高筛查率，进而挽救更多的生命。

英文原文：FDA Approves Exact Sciences' Cologuard?; First and Only Stool DNA Noninvasive Colorectal Cancer Screening Test

First time in history a technology receives FDA approval and proposed national coverage by CMS on the same day

Screening test detects 92% of colorectal cancer

MADISON, Wis., Aug. 12, 2014 /PRNewswire/ -- Exact Sciences Corp. (EXAS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cologuard, the company's noninvasive, stool DNA colorectal cancer screening test. Cologuard is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers and has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients. Cologuard, which is available through healthcare providers, offers people 50 and older at average risk for colorectal cancer an easy-to-use screening test they can do in the privacy of their own home.

Upon approval, Exact Sciences also received a proposed coverage memorandum from the Centers for Medicare and Medicaid Services (CMS). Cologuard is the first product to take part in the joint FDA and CMS parallel review pilot program in which both agencies simultaneously review medical devices to help reduce the time between FDA approval and Medicare coverage. A final National Coverage Determination is expected to be posted in October/November of this year after a public comment period.

Colorectal cancer is considered the most preventable, yet least prevented cancer due to the lack of patient compliance with screening.  An estimated 23 million Americans between 50 and 75 are not getting screened as recommended and as a result, colorectal cancer remains the second-leading cancer killer in the U.S. For those whose cancer is detected at an earlier stage, the five-year survival rate can be greater than 90 percent.

"Colorectal cancer is highly preventable and following the recommended screening guidelines can lead to life-saving early detection," said Eric Hargis, CEO, Colon Cancer Alliance. "In more than 60 percent of all cases, colorectal cancer is not detected until its late stages, making treatment more challenging. New, patient-friendly screening options are desperately needed to prevent colorectal cancer or help identify it early, when it is most treatable. Given that more than half of colorectal cancer-related deaths could be avoided with regular screenings, having Cologuard as another option for people who have resisted getting a colonoscopy could result in many lives being saved and screening compliance rates to increase."

Cologuard is designed to detect biomarkers from DNA in cancer that is shed from the colon as part of the digestive process and blood released in the stool. After the physician orders Cologuard, the kit is mailed directly to the patient's home. The patient then collects a stool sample in the Cologuard Collection Kit and sends the kit back to the Exact Sciences lab for testing through a pre-paid mailer.

At the lab, the stool sample is analyzed in an automated system to yield a single test result¡ªpositive or negative for the presence of precancerous polyps or cancer. Results from the Cologuard test are turned around in as little as two weeks, and patients learn their results directly from their prescribing physician. Unlike many other screening options, Cologuard does not require medication or dietary restrictions, or bowel preparation prior to taking the test.

"The robustly conducted research as part of this FDA approval process has proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer," said David Ahlquist, M.D., a Mayo Clinic gastroenterologist and co-inventor of the test. "The test is designed for high accuracy, ease of patient use, and wide accessibility. We hope that it will make a difference and save many lives."

"The FDA approval of Cologuard represents a major achievement in Exact Sciences' mission to make a noninvasive, patient-friendly screening test for colorectal cancer available," said Kevin Conroy, President, CEO and Chairman of Exact Sciences. "Cologuard addresses a critical need for a more convenient screening option for patients to aid in prevention and early detection. Exact Sciences is committed to making Cologuard available and accessible to patients and looks forward to advancing cancer detection in other gastrointestinal cancers. On behalf of the Exact Sciences team, I would like to thank the FDA and CMS for allowing us to go through the parallel review process."

Results from the company's DeeP-C Study, prospective, 90-site, 10,000-patient pivotal study¡ªone of the most extensive colorectal cancer screening studies ever conducted in the U.S.¡ªwere published in April 2014 in the New England Journal of Medicine's, "Multi-target Stool DNA Testing for Colorectal-Cancer Screening".

Cologuard is available to patients through their healthcare providers in the U.S. for $599.  Exact Sciences has plans to make Cologuard available in select countries in Europe pending CE Mark. For more information, visit www.CologuardTest.com or call 1-844-870-8870. More information on colon cancer and the importance of screening and early detection at http://www.beseengetscreened.com/. Visit www.exactsciences.com to sign up for the company's eNewsletter.

Dr. David Ahlquist, professor of medicine at Mayo Clinic, is the inventor of the technology that has been licensed to Exact Sciences from Mayo Clinic. Under that licensing agreement, Mayo Clinic and Dr. Ahlquist share in equity and royalties. Revenue Mayo Clinic receives is used to support Mayo's not-for-profit mission in patient care, education and research.

About Exact Sciences Corp.

Exact Sciences Corp. (EXAS) is a molecular diagnostics company focused on the early detection and prevention of colorectal cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Stool DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer.