First and only FDA-approved noninvasive stool DNA screening test for colorectal cancer
MADISON, Wis.--(BUSINESS WIRE)-- Exact Sciences Corp. (NASDAQ: EXAS) today announced Wheaton Franciscan Healthcare is the first healthcare system in Milwaukee to offer Cologuard®, the first and only FDA-approved noninvasive stool DNA screening test for colorectal cancer. Cologuard makes it easy for average risk patients 50 years and older to get screened at their convenience and in the privacy and comfort of their own home without having to worry about taking time off work to prepare for an invasive procedure.
"Wheaton is pleased to be the first system in Milwaukee to utilize Cologuard," said Dr. Paul Hartlaub, Wheaton Franciscan Healthcare's Medical Director for Clinical Quality and Population Health. "Although we still recommend the colonoscopy for eligible patients because it is more effective for early detection of colon cancer, we are excited to provide an alternative option in order to increase the number of people being screened."
Cologuard analyzes a person's stool to detect both altered DNA and blood known to be associated with colorectal cancer or pre-cancer. Cologuard is available by prescription only for people age 50 and over at average risk for colon cancer (no prior history with polyps or cancer, and no family history with colon cancer.)
Colorectal cancer is the second-leading cancer-related cause of death in the United States. It is often considered a highly preventable cancer, yet is the least prevented cancer due to the lack of patient compliance with current screening options. Most colorectal cancers develop slowly over several years. Before cancer develops, a polyp—a non-cancerous growth—usually appears on the inner lining of the colon or rectum. Identifying and removing these polyps, through routine screenings, can effectively prevent colorectal cancer. For those whose cancer is detected at an early stage, the five-year survival rate can be greater than 90 percent, making routine screening critical. Unfortunately, 23 million Americans aged 50 and over do not get screened as recommended.
"The more effective options you can provide for patients to get regular colon cancer screenings, the more opportunity we have to improve early detection and survival rates for this dangerous disease," said Dr. Paul Hartlaub.
After a healthcare provider orders Cologuard, the test is delivered directly to the patient's home. The patient collects a stool sample in the collection container provided and sends the test back to the lab for testing using a pre-paid mailer. Results are turned around in as little as two weeks and patients learn their results from their healthcare provider.
"Wheaton's adoption of Cologuard provides access to an important new screening tool for colorectal cancer to a population that may otherwise never get screened," said Kevin Conroy, Chairman and CEO of Exact Sciences. "Colon cancer is very treatable when caught early, making compliance with screening even more critical. We look forward to working with the healthcare providers at Wheaton to provide another screening option."
Cologuard is the first and only noninvasive stool DNA test approved by the FDA for colorectal cancer screening. 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 colorectal cancer screening guidelines of the American Cancer Society and stool DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer.
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 www.CologuardTest.com. Rx Only.
About Wheaton Franciscan Healthcare
Wheaton Franciscan Healthcare is a Catholic, not-for-profit organization with more than 100 sites in Wisconsin, Iowa, and Illinois including 14 hospital campuses, three transitional and extended care facilities, two home health agencies, nearly 3,000 physicians, 70 clinic sites with more than 500 employed physicians, and more than 17,000 associates. Started more than 130 years ago and formally incorporated in 1983, the System is sponsored by the Wheaton Franciscan Sisters. Corporate services offices are located in Wheaton, Illinois and Glendale, Wisconsin. For more information visit www.mywheaton.org, Facebook.com/wheatonwi, or Twitter: @wheatonfwi.
About Exact Sciences Corp.
Exact Sciences Corp. (NASDAQ: EXAS) is a molecular diagnostics company focused on the early detection and prevention of colorectal cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.
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Media Contact for Exact Sciences:
Media Contact for Wheaton:
Anne Ballentine, 414-465-3605
Jess Owens, 414-465-3351
Source: Exact Sciences Corp.