On January 12, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that data published today in Cancer Prevention Research, a Journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), that expands on foundational clinical study findings to include a key younger population (Press release, Exact Sciences, JAN 12, 2021, View Source [SID1234573929]). Study results show that among average-risk adults between the ages of 45 and 49 Cologuard (mt-sDNA) demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions or negative findings at colonoscopy and 96.3% in only those with negative colonoscopy findings. These analyses support potential risk mitigation and cost prevention due to unnecessary diagnostic procedures when using Cologuard as a colorectal cancer screening tool in this younger population.
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Cologuard is a U.S. Food & Drug Administration (FDA)-approved, non-invasive stool DNA test for colorectal cancer for average-risk people. In September 2019, the FDA approved Cologuard for average-risk individuals beginning at age 45, expanding the Cologuard label to include this critical younger adult population.
Study is among the first to evaluate the use of a colorectal cancer screening method in patients between ages of 45-49.
"These new data support the critical role an effective, non-invasive option like Cologuard plays in screening people ages 45 to 49," said Kevin Conroy, chairman and CEO of Exact Sciences. "Cologuard may appeal to this younger screening population because they can collect sample at home, without missing work or undergoing bowel prep and anesthesia, and only those patients with a positive Cologuard will require a diagnostic colonoscopy."
In a previously published, large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers, including 94% in stages I and II. Specificity for this over 50 population was 87%.
Colorectal cancer is the second leading cause of cancer death for men and women in the United States, in part because many cancers go undetected until later stages when treatment is less effective. Colorectal cancer can be prevented or detected early through screening; however, approximately 44 million Americans remain unscreened, including an estimated 19 million between ages 45 and 49.
The incidence of colorectal cancer in people under the age of 50 has dramatically increased in the last 20 years. Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50. More than half of these cases were diagnosed at an advanced stage, stage III or stage IV, when survival rates are low.
"This study is among the first to evaluate the use of a colorectal cancer screening method in patients between the ages of 45 and 49," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "The American Cancer Society guidelines and the 2020 draft United States Preventive Services Task Force (USPSTF) guidelines now say that screening should begin at 45, and these data support the use of Cologuard as a first line screening option."
The prospective study included 816 evaluable participants who all completed a Cologuard test and underwent a colonoscopy. Participants were enrolled at 31 sites in the United States from November 2018 through June 2019. They completed Cologuard, followed by a screening colonoscopy within approximately 60 days of enrollment. Participants collected their sample for the Cologuard test prior to doing any bowel preparation necessary for the colonoscopy. All colonoscopies were performed blinded to the Cologuard results.
Specificity was the primary outcome and was measured in participants without colorectal cancer or advanced precancerous lesions and in the subgroup of participants with negative colonoscopic findings. None of the study participants had colorectal cancer, 49 had advanced precancerous lesions, 253 had non-advanced adenomas and 514 had negative colonoscopies. Specificity did not differ between men and women.