Exact Sciences Applauds Final Task Force Recommendation That Lowers Starting Age for Colorectal Cancer Screening to 45
National Task Force supports Cologuard® as a screening option and screening expands to an additional ˜19 million Americans
MADISON, Wis. – May 18, 2021 – The United States Preventive Services Task Force (USPSTF) today released its final colorectal cancer screening recommendation that screening begin at age 45. Exact Sciences’ (NASDAQ: EXAS) Cologuard®, referred to as sDNA-FIT, is included as a recommended screening option for all average-risk patients between the ages of 45 and 75.
Colorectal cancer is the second leading cause of cancer death in the United States, in part because many cancers go undetected until later stages when treatment options are limited.1 Colorectal cancer can be prevented or detected early through screening. However, approximately 44 million average-risk adults 45-74 are currently eligible for screening, including ˜19 million between the ages of 45 and 49.2§
According to this updated recommendation, all average-risk adults age 45 and older should now be screened for colorectal cancer. Colorectal cancer incidence has been increasing in American adults under the age of 50.3 Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50.4 More than half of these cases were diagnosed at later stages (stages III or IV), which are associated with lower survival rates than earlier stages (stages I or II).4 Only about one out of 10 people over the age of 50 with stage IV colorectal cancer survives beyond five years.1
“Health care providers often turn to USPSTF recommendations when discussing cancer prevention with their patients,” said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. “This final recommendation will encourage more clinicians to offer colorectal cancer screening to their patients starting at age 45.”
Cologuard is a U.S. Food & Drug Administration (FDA)-approved non-invasive stool DNA test used to screen for colorectal cancer in average risk patients. In a large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers,5 including 94% in stages I and II.5,6,7* 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.
A recent study showed that among average-risk adults between the ages of 45 and 49, Cologuard demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions.8 In patients with negative colonoscopy findings, Cologuard demonstrated specificity of 96.3%.8 According to the authors, using Cologuard to screen these younger individuals could help mitigate risks and reduce costs from unnecessary diagnostic procedures.
The USPSTF recommendation plays a key role in addressing the public health crisis caused by colorectal cancer. Under this final recommendation, colorectal cancer screening remains a Grade A recommendation for people ages 50-75 and screening for ages 45 to 49 is a Grade B recommendation. The task force continues to include Cologuard (referred to in the recommendation as sDNA-FIT) among the recommended screening test options. Since it was first included in the 2016 USPSTF recommendation, Cologuard has been used to screen more than 5 million Americans.
“We are proud of the role Cologuard has played in getting more people screened for colorectal cancer,” said Kevin Conroy, chairman and CEO of Exact Sciences. “The task force's recommendation that colorectal cancer screening begin at age 45 for all average risk people means that Cologuard can continue to positively impact screening rates as people work with their healthcare providers to choose the option that is right for them.”
Making sure people have full access to using stool-based tests like Cologuard is critical to reaching the unscreened. A recent study conducted by researchers at Mayo Clinic showed that when given a choice, most individuals at average risk of colorectal cancer said they would prefer a stool-based screening test for colorectal cancer over colonoscopy.9
* Statistic calculated using data from the pivotal study and reported within the Ahlquist review article. Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).1
§ Estimates based on US population aged 45-74 and 45-49 as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.
