EXACT SCIENCES ANNOUNCES NORTON HEALTHCARE TO ADOP
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First and only FDA-approved noninvasive stool DNA screening test for colorectal cancer
MADISON, Wis.--(BUSINESS WIRE)-- Exact Sciences Corp. (NASDAQ: EXAS) today announced Norton Healthcare is the first healthcare system in Kentucky 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.
"Norton Healthcare is proud to be the first healthcare provider in Kentucky to offer this important new advancement that can help increase screening compliance for colon cancer," said Dr. Thomas Woodcock, an Oncology Specialist with the Norton Healthcare Cancer Institute. "The decision to offer this at-home screening tool reflects the commitment of the Norton Cancer Institute to lead the way in innovative cancer care and prevention."
Cologuard is approved for those who are age 50 and over, and have average risk for colon cancer (no prior history with polyps or cancer, and no family history with colon cancer). A physician's prescription is required for the test, which analyzes a person's stool to detect both altered DNA and blood known to be associated with colorectal cancer or pre-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 resources you can provide that make it easier and more convenient for patients to get regular colon cancer screenings, the more opportunity we have to improve early detection and survival rates for this preventable cancer," said Robert W. Shaw, M.D., Norton Community Medical Associates.
After the 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. Any positive result is communicated by a personal phone call to the ordering physician, who will inform the patient. A positive result should be followed by a diagnostic colonoscopy.
"Norton Healthcare'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, President, CEO and Chairman 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 Norton toward a future where colorectal cancer is survived more often."
Cologuard was approved by the FDA in August 2014. Results from Exact Sciences' prospective 90-site, point-in-time 10,000-patient pivotal trial—one of the most extensive colorectal cancer screening studies ever conducted in the United States by a device manufacturer—were published in March 2014 in the New England Journal of Medicine: "Multi-target Stool DNA Testing for Colorectal-Cancer Screening."
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