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Medicare & Medicaid News

Medicare to Cover First Stool DNA Test for Detection of Colorectal Cancer

Medicare & You logoCologuard the first and only FDA-approved noninvasive stool DNA screening test for colorectal cancer

Oct. 10, 2014 – Exact Sciences Corp. announced yesterday that Centers for Medicare & Medicaid Services issued its final National Coverage Determination (NCD) for Cologuard, making it the first and only Food and Drug Administration (FDA) approved stool DNA test for the detection of colorectal cancer and precancer covered by Medicare. Coverage will go into effect immediately.

Exact Sciences is still awaiting a preliminary pricing determination from CMS, but investors did not wait, as the stock climbed rapidly on Friday.

 

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FDA Approves First Non-Invasive DNA Screening Test for Colorectal Cancer

Collaboration with Centers for Medicare & Medicaid Services contributed to proposed Medicare coverage for Cologuard

Aug. 19, 2014 - The U.S. Food and Drug Administration on August 11 approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer. More...

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The NCD was based on the comprehensive review by the federal government agency as part of the FDA and CMS parallel review pilot program. Cologuard is the first medical device to receive FDA approval and a final NCD as part of the parallel review process.

"We are pleased with CMS' final coverage determination for Cologuard and would like to thank both CMS and FDA for giving Exact Sciences the opportunity to participate in the parallel review pilot program," said Kevin Conroy, President, CEO and Chairman of Exact Sciences.

Cologuard vs Fecal Immunochemical Test (FIT)

Cologuard detected 92% of colorectal cancers, 42% of advanced adenomas.

FIT screening  detected 74% of cancers, 24% of advanced adenomas.

See news report 8/19/2014

"Colorectal cancer is often considered the most preventable, yet least prevented cancer due to the lack of patient compliance with screening. CMS's decision to cover Cologuard will provide Medicare's 50 million patients with access to this accurate screening option."

Following is how the company describes Cologuard and its role -

"Colorectal cancer is highly treatable with early detection through screening. However, 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 United States. For those whose cancer is detected at an earlier stage, the five-year survival rate can be greater than 90 percent.

"Cologuard offers people 50 years and older who are at average risk for colorectal cancer an easy to use screening test which they can do in the privacy of their own home. Cologuard has been proven to find 92 percent of colorectal cancers in average risk patients with 87 percent specificity.

"Cologuard does not require medication, dietary restrictions or bowel preparation prior to taking the test. It is the first noninvasive screening test for colorectal cancer that analyzes both stool-based DNA and blood biomarkers to detect cancer and precancer.

Decision by Centers for Medicare & Medicaid Services, October 9, 2014

After considering public comments and consulting with appropriate organizations, the Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to cover CologuardTM – a multitarget stool DNA test – as a colorectal cancer screening test for asymptomatic, average risk beneficiaries, aged 50 to 85 years.  

Therefore, Medicare Part B will cover the CologuardTM test once every three years for beneficiaries who meet all of the following criteria:

Age 50 to 85 years,

Asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and

At average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).

All other screening stool DNA tests not otherwise specified above remain nationally non-covered. 

The final NCD can be found online: http://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=277

About Exact Sciences Corp.

Exact Sciences Corp. (NASDAQ: 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. For more information, visit the company's website at www.exactsciences.com.

 

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