Cologuard in the News: Week One

Following last week's announcement of the approval of Cologuard by the U.S. Food and Drug Administration (FDA), there has been quite a bit of media buzz surrounding the new noninvasive, DNA-based colon cancer screening test.

The Cologuard story has received national media attention, and here we've compiled some of the most noteworthy news coverage and press releases from the first week of Cologuard, post-FDA approval.

U.S. Food and Drug Administration (FDA)

Media representatives from the FDA issued a news release on the government website August 11th, titled, "FDA approves first non-invasive DNA screening test for colorectal cancer." The release provides general information on colon cancer and colon cancer screening, and specific details about the science and clinical testing behind Cologuard. The press release also offers an explanation of Cologuard as the first product to be reviewed through a joint FDA-CMS pilot program known as parallel review.

“This approval offers patients and physicians another option to screen for colorectal cancer,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Fecal blood testing is a well-established screening tool and the clinical data showed that [Cologuard] detected more cancers than a commonly used fecal occult test.”

The Wall Street Journal

On Monday, August 11th, the Wall Street Journal published an article titled, "FDA Approves DNA Test for Colon Cancer" in which the reporter discusses the way patients can access Cologuard, the impact this test could have on colon cancer screening, and implications for Medicare patients.

"[Colon cancer] can often be effectively treated if detected early enough, but many people avoid colonoscopy screening out of fear it will be painful and time-consuming. Minimally-invasive tests like Cologuard may help encourage more people to be tested, doctors say."


A reporter for WebMD covered the Cologuard story in the website's Health News section on Thursday August 14th. The article, "New At-Home Colon Cancer Test: FAQ," features several common questions about Cologuard, answered by several physicians.

"The test, called Cologuard, is 'another weapon in our arsenal for colon cancer screening,' says James Lin, MD. He's a clinical assistant professor of gastroenterology at the City of Hope Comprehensive Cancer Center."


Xconomy, a prominent leader in news and insights for business and technology, reported on the approval of Cologaurd and its implications for Exact Sciences, consumers, investors, and the biotechnology community at large. The article, "Exact Sciences’ Cologuard Approved Simultaneously by FDA, CMS," can be found on the Xconomy website.

"The announcement isn’t a surprise, given the unanimous endorsement of the test in March by an FDA advisory panel that reviewed data from the company’s 10,000-patient clinical study. But it’s a huge deal nonetheless for Madison, WI-based Exact (NASDAQ: EXAS), which has nearly completed a remarkable turnaround after investors left it for dead five years ago."

American Association of Retired Persons (AARP)

On Tuesday, August 12th AARP published a story titled, "FDA Approves At-Home DNA Test for Colon Cancer," about Cologuard on the organization's blog. Because AARP's audience is primarily comprised of individuals who meet the recommended age requirement for colon cancer screening, the post included useful details about insurance coverage and reimbursement for the test that would be particularly relevant to patients aged 50 years or older.

“ 'This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day,' Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS, said in the FDA announcement."

CBS News

CBS News published an article titled, "FDA approves first DNA test for colon cancer," on Monday August 11th covering the Cologuard story. The article features information on Cologuard and expert input from Dr. Jon LaPook, the chief medical correspondent for CBS who commented on the test in March.

"Doctors have long used stool tests to look for hidden blood that can be a warning sign of tumors and precancerous polyps. But company studies of Cologuard showed that it was more accurate at detecting cancerous tumors and worrisome polyps than traditional stool blood tests."


A reporter for HealthDay published "FDA Approves Highly Accurate At-Home Colon Cancer Test," on Monday August 11th. The article emphasizes the Cologuard's accuracy and the cutting-edge DNA technology with which the test was developed.

An accurate, noninvasive test would be a huge addition to the fight against colon cancer, experts say. That's because one-third of Americans fail to heed public health recommendations to undergo invasive colonoscopy every 10 years starting at age 50, explained study co-author Dr. Steven Itzkowitz

To learn more about the science behind Cologuard and how to order the test through your doctor, go to

Cologuard® is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals. Cologuard is available by prescription only.

Both false positives and false negatives do occur. In a clinical study of Cologuard, 13% of people without cancer or precancer tested positive. Any positive should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. The performance of Cologuard has been established in a cross sectional study (i.e., single point in time). Programmatic performance of Cologuard (i.e., benefits and risks with repeated testing over an established period of time) has not been studied.  Performance has not been evaluated in adults who have been previously tested with Cologuard. Non-inferiority or superiority of Cologuard programmatic sensitivity as compared to other recommended screening methods for CRC and AA has not been established.

Topics: Colon Cancer News and Information, Exact Sciences News

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