Medicare to Cover First Stool DNA
Test for Detection of Colorectal Cancer
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
Exact Sciences is still
awaiting a preliminary pricing determination from CMS, but investors did
not wait, as the stock climbed rapidly on Friday.
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.
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
for giving Exact
the opportunity to participate in the parallel review pilot program,"
Kevin Conroy, President, CEO and
Chairman of Exact
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.
"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.
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 Crohns 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
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
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