Cologuard® in the News: Week Two

Following the 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 second week of Cologuard, post-FDA approval.

Colon Cancer Alliance

Our friends at Colon Cancer Alliance also contributed to the Cologuard buzz. A reporter published a story on the CCA blog August 15th titled, "Colon Health Alert: FDA Approves New CRC Screening Test," which features a Q&A about Cologuard. 

"Cologuard only requires one bowel movement ... does not require diet modifications and is able to look for blood and altered DNA."


OncLive, a prominent news resource within the oncology community, reported on Cologuard August 11th. The article, titled "FDA Approves First DNA-Based CRC Screening Tool," provides an in-depth explanation of the DeeP-C pivotal study and the DNA-based technology behind Cologuard.

“The Cologuard test, which is manufactured by Exact Sciences, uses quantitative molecular assays for KRAS mutations, abnormalities in methylated BMP3, NDRG4, and β-actin along with a hemoglobin immunoassay. The approval for the test follows a unanimous recommendation from the FDA's Molecular and Clinical Genetics advisory committee in March 2014.”

The Wisconsin State Journal

On Tuesday, August 12th, the Wisconsin State Journal published an article titled, "Exact Sciences wins FDA approval for non-invasive colorectal cancer test" in which the reporter discusses the science behind Cologuard and the group of patients for whom it is intended. The story also includes information on Exact Sciences as a company.

"Research analyst Jeffrey Elliott, of Robert W. Baird & Co., welcomed the news. 'Importantly, we believe the approval language clearly positions Cologuard as a primary screening option ... "

Associated Press

A reporter for HealthDay published "FDA Approves First DNA-Based Test For Colon Cancer," on Monday August 11th. The article offers background information on colorectal cancer incidence and mortality rates, and explains how Cologuard could impact the entire colon cancer screening landscape.

"The approval has the potential to reshuffle current medical practice, though FDA officials stressed Monday that DNA-based stool screening has not been endorsed by federal medical advisers who set screening guidelines."


Bloomberg, a leader in global business and financial information, reported on the approval of Cologaurd August 12th. The article, "Exact Sciences Wins U.S. Approval for Colon Cancer Test," can be found on the Bloomberg website.

"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."


Newsy, a global video news source, reported on Cologuard August 12th. The story is called "FDA Approves Take-Home Colon Cancer Test and discusses the impact Cologuard could have on colon cancer screening rates.

"In the press release, the FDA said as many as 60 percent of colon cancer deaths could be avoided if people were getting properly screened. So the hope is that people who won't get colonoscopies might at least use take-home tests."

Here's the video clip:

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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