More than 1 Million Screened for Colorectal Cancer with Cologuard


Noninvasive test is changing how Americans get checked for the most preventable form of cancer

MADISON, Wis., Feb. 26, 2018 /PRNewswire/ -- More than 1 million patients have been screened for colorectal cancer with Cologuard, Exact Sciences Corp. (Nasdaq: EXAS), the maker of the test, announced today.  This milestone comes less than four years after the noninvasive screening test was approved by the FDA and covered by Medicare, making it one of the most quickly adopted diagnostic technologies of all time.  

Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

"Colorectal cancer screening rates are stubbornly low, leaving millions of Americans unscreened for the No. 2 cancer killer," said Kevin Conroy, chairman and CEO of Exact Sciences. "Cologuard was designed to help more people get screened and it is doing just that. Approximately half of Cologuard users haven't been screened before and we're excited that health care professionals and patients around the country are making Cologuard their noninvasive screening test of choice."

One of the million screened with Cologuard is Brenda Boutin, 58, of Savannah, Ga. After discussing the test with her nurse practitioner, Brenda used Cologuard in the privacy of her home and returned it to Exact Sciences Labs using a prepaid UPS shipping label supplied with the test.

"Cologuard is a breeze," Brenda said. "You don't have any prep for it. There's nothing else to it. Seal it up, put it back in the box and send it off. It's so simple to use."

Cologuard tests are processed in Exact Sciences' Madison, Wis. lab and results are sent directly to the health care provider's office.  This ensures that the provider-patient relationship remains at the center of the screening process. A positive result indicates that Cologuard detected biomarkers associated with colorectal cancer or advanced adenoma, and should be followed up with a diagnostic colonoscopy.

This was the case for Brenda. Following a positive result, she returned to her doctor and follow-up testing revealed the presence of Stage I colon cancer. Brenda needed minimally-invasive laparoscopic surgery to remove part of her colon, but no other treatment. After only two weeks, Brenda resumed her normal lifestyle and went back to work.

"Many people have asked why I took the Cologuard test," Brenda said. "My experience with Cologuard made them aware that if we detect cancer earlier, even in one person, it's well worth it. My cancer was caught early, when it is highly treatable. I had a guardian angel."

Today, Brenda says she is cancer-free. She and her husband have resumed their busy lives and enjoy traveling around the country as they celebrate Brenda's good health.

"I feel blessed that my colon cancer was caught at an early stage and I didn't have to have any other treatment," she said.

Colorectal cancer is known as one of the most preventable, yet least prevented cancers. More than 140,000 Americans are diagnosed with colorectal cancer each year and the cancer takes the lives of 50,000 Americans per year, more than breast cancer (41,000 deaths per year) and prostate cancer (26,000 deaths per year). Despite colorectal cancer's preventability, more than 35 million Americans age 50 and older—about one in three—are not current with screening guidelines.

Early detection is critical to battling colon cancer. When the disease is detected in Stage I, patients have a 94-percent five-year survival rate and the removal of precancerous lesions can prevent the disease.

Cologuard is intended for use by adults age 50-plus at average risk for colorectal cancer. To learn more about Cologuard visit

About Cologuard
Cologuard was approved by the FDA in August 2014 and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the recommendations of the U.S. Preventive Services Task Force (2016) and the American Cancer Society's (2014) colorectal cancer screening guidelines. Stool-DNA is included in the combined screening guidelines of the American Cancer Society / U.S. Multi-Society Task Force/American College of Radiology (2008), the American College of Gastroenterology guidelines (2009) and the National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result 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. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit Rx Only.

Contact:  Scott Larrivee, Exact Sciences, 608-535-8673,


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