Cologuard® in the News: Week Three

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 third week of Cologuard, post-FDA approval.

ABC News

ABC News ran a segment on Cologuard, titled "New at Home Colon Cancer Test Could Change the Course of History." The segment features an appearance by Exact Sciences CEO Kevin Conroy, who discusses the groundbreaking technology on which Cologuard is based, and the impact this test could have on the eradication of colon cancer.

"Again, [there are] eighty million Americans who need to be regularly screened. Right now, the amazing thing is we're spending $14 billion in this country — 75% of that by Medicare — to treat colon cancer. If we spent that money upfront, screening, we could eradicate the disease, and that is our goal."

Here's the clip:

CBS Minnesota

A reporter from CBS Minnesota covered the partnership between Exact Sciences and the Mayo Clinic, news that broke on August 25th. The article, titled, "Mayo Clinic to Offer At-Home Test For Colon Cancer," provides background on colon cancer screening and explains that the Mayo Clinic will offer Cologuard through its healthcare providers.

“'The most important advance and why this test is really revolutionary is that this will allow a larger percentage of the population that needs screening to undergo screening,' said Dr. Vijay Shah, a Mayo Clinic gastroenterologist.

The Wisconsin State Journal

On Sunday, August 31st, the Wisconsin State Journal published an article titled, "Exact Sciences' Cologuard cancer test debuts" in which the reporter discusses the commercialization of Cologuard and how Exact Sciences plans to work with healthcare systems and providers to implement the product (and future projects) to reach the general population.

"With the U.S. on board, Exact is expected to seek approval for Cologuard overseas. And Cologuard could be the first of a series of screening tests Exact will develop with the Mayo Clinic for other GI tract ailments."


The Associated Press published "Mayo Clinic to offer at-home colon cancer test," on Tuesday August 26th. The article explains Exact Sciences' collaboration with Mayo Clinic throughout the development, clinical testing, and implementation of Cologuard throughout the years. 

"The Star Tribune reports officials announced Monday the Rochester clinic will be the nation's first to provide patients with a new at-home colon cancer test."

The Journal Sentinel

A reporter from this Milwaukee-based newspaper also covered the Mayo Clinic announcement Monday, August 25th. In the article, "Mayo to offer Exact Sciences colon cancer screening test," she explains the implications Cologuard could have for the current colon cancer screening landscape as a whole.

"'Low screening rates have long contributed to low survival rates for colorectal cancer, with more than 60% of all cases not detected until late stages of the disease,' said David Ahlquist, a Mayo Clinic gastroenterologist and co-inventor of the test. 'I am hopeful that the test's efficacy and convenience will result in improved detection and survival rates for colorectal cancer.'"

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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