MADISON, Wis., May 30, 2018 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS) strongly supports the American Cancer Society's (ACS) update to its colorectal cancer screening guidelines announced today. The new guidelines recommend colorectal cancer screening begin at age 45 for people at average risk of the disease. With more than 20 million Americans age 45-49, Exact Sciences affirmed its commitment to seek U.S. Food and Drug Administration (FDA) approval for making Cologuard, its noninvasive colorectal cancer screening test, available to those in this population who are at average risk for colorectal cancer.
"The American Cancer Society should be praised for taking a critical step toward helping more Americans get screened for colorectal cancer and potentially detecting the disease earlier," said Kevin Conroy, chairman and CEO of Exact Sciences. "Today's announcement recognizes the benefits of recommending screening for younger adults, particularly given the mounting evidence that the incidence of this disease is increasing for people under age 50. Cologuard is already one of the American Cancer Society's recommended colorectal cancer screening tests."
Colorectal cancer is the second leading cause of cancer deaths in the United States1 and the incidence of colorectal cancer among people age 40-49 has been on the rise. According to the ACS's updated screening guidelines, among adults younger than 55 years, there was a 51 percent increase in the incidence of colorectal cancer from 1994 to 2014 and an 11 percent increase in mortality from 2005 to 2015. Colorectal cancer can be treated if detected in its early stages. When caught in its precancerous stage, colorectal cancer is even preventable.
Cologuard is currently available to individuals age 50 and older who are at average risk for colorectal cancer. More than 1.1 million people have completed the noninvasive, easy-to-use test that can be used at home following a prescription from a health care provider. Exact Sciences will seek to expand the product's current indication to people age 45 and older who are at an average risk for colorectal cancer.
The updated ACS guidelines note that, "Although prevention is highly valued by patients, test preparation, invasiveness, potential costs, and other considerations will lead some patients to prefer a noncolonoscopy test for screening. Greater value was placed on the role of patient preferences and on the potential to increase CRC screening utilization through offering choice in screening test options."
"Based on the science behind Cologuard, and the multiple rigorous studies supporting its performance, we believe that further clinical data will demonstrate Cologuard would be well-suited for screening individuals beginning at age 45," said David Ahlquist, M.D., gastroenterologist at Mayo Clinic and co-developer of Cologuard. "We believe that Cologuard's performance, coupled with the fact that it is non-invasive and performed conveniently at home with no time off work and without any special prep requirements, would make it an ideal screening choice for individuals ages 45 to 50."
Mayo Clinic and Dr. Ahlquist have a financial interest in the product referenced in this news release.
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 for everyone; not for high risk individuals, including those with a family history of colorectal cancer, a personal history of colorectal cancer or advanced adenoma, IBD and certain hereditary syndromes. Positive Cologuard results should be referred to diagnostic colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. 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. Rx only.
About Exact Sciences
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.
1 Centers for Disease Control and Prevention. Vital signs: colorectal cancer tests saves lives. https://www.cdc.gov/vitalsigns/colorectalcancerscreening/. Updated November 2013.
Exact Sciences Corp
Contact: J.P. Fielder