Stool-based DNA (sDNA) screening test for colorectal cancer to be available by prescription to patients
MADISON, Wis. & ROCHESTER, Minn.--(BUSINESS WIRE)--
Exact Sciences Corp. (EXAS) today announced that Mayo Clinic will be the first health system to offer Cologuard®, the first and only Food and Drug Administration (FDA) approved, noninvasive stool DNA screening test for colorectal cancer. Cologuard will be available to patients through their primary care physicians at Mayo Clinic.
News Conference Advisory: An audio news conference is scheduled for Monday, Aug. 25 at 11 a.m. EDT/10 a.m. CDT. Representatives from Exact Sciences Corp. and Mayo Clinic will be available for questions. Call-in number for journalists: 800-763-5545
Available by prescription only, Cologuard offers people 50 years and older who are at average risk for colorectal cancer an easy to use screening test which they can do in the privacy of their own home. It is the first noninvasive screening test for colorectal cancer that analyzes both stool-based DNA and blood biomarkers to detect cancer and precancer. The Cologuard technology platform was co-developed by Exact Sciences Corp. and Mayo Clinic as part of a broad, exclusive collaboration.
“Cologuard represents a significant advancement in identifying colorectal cancer at its most treatable stage. We believe offering this new tool will promote patient and community public health and may move more patients to get screened earlier—a critical step in beating this prevalent and preventable cancer,” says Vijay Shah, M.D., chair of Mayo Clinic gastroenterology and hepatology.
Colorectal cancer is highly preventable with screening. However, twenty-three million Americans between 50 and 75 are not getting screened as recommended and, as a result, colorectal cancer remains the second-leading cancer killer in the United States. For those whose cancer is detected at an earlier stage, the five-year survival rate can be greater than 90 percent.
“Mayo Clinic’s adoption of Cologuard marks a significant step forward in providing patients access to this important new cancer screening technology,” said Kevin Conroy, president, CEO and chairman of Exact Sciences Corp. “We look forward to continuing our collaboration with the Mayo Clinic to develop a growing pipeline of diagnostic screening innovations for GI tract cancers.”
Cologuard is designed to detect DNA alternations and blood released from cancer and precancerous colon lesions. The test requires a physican order. After the physician orders Cologuard, the kit is mailed directly to the patient’s home. The patient then collects a stool sample in the Cologuard Collection Kit and sends the kit back to the Exact Sciences lab for testing through a pre-paid mailer.
Patients learn of their results in as little as two weeks from their physician. Patients with a positive result will need to undergo colonoscopy.
“Low screening rates have long contributed to low survival rates for colorectal cancer, with more than 60 percent of all cases not detected until late stages of the disease,” said David Ahlquist, M.D., a Mayo Clinic gastroenterologist and co-inventor of the test. “I am hopeful that the test’s efficacy and convenience will result in improved detection and survival rates for colorectal cancer.”
For more information, visit www.CologuardTest.com or call 1-844-870-8870. More information on colon cancer and the importance of screening and early detection at sign up for the company’s eNewsletter.
Disclosure statement - David Ahlquist, M.D., is a co-inventor of the technology that has been licensed to Exact Sciences from Mayo Clinic. Under that licensing agreement, Mayo Clinic and Dr. Ahlquist share in equity and royalties. Revenue Mayo Clinic receives is used to support Mayo's not-for-profit mission in patient care, education and research.
About Exact Sciences Corp.
Exact Sciences Corp. (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. Stool DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please visit the company's website at, follow us on Twitter ExactSciences or find us on Facebook.
About Mayo Clinic
Recognizing 150 years of serving humanity in 2014, Mayo Clinic is a nonprofit worldwide leader in medical care, research and education for people from all walks of life. For more information, visit 150 years..
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Comment Period: 08/11/2014-09/10/2014
The USPSTF gives an “A” recommendation to two other colorectal cancer screening procedures in addition to colonoscopy – high-sensitivity fecal occult blood test (FOBT) and flexible sigmoidoscopy for most adults 50 years of age until 75 years of age.§ For these procedures, the USPSTF recommends high-sensitivity FOBT on an annual basis or flexible sigmoidoscopy every 5 years combined with high-sensitivity FOBT every 3 years. A high-sensitivity FOBT detects microscopic bleeding that patients would otherwise not notice because it is not visible in the stool. These other procedures are less invasive, pose lower risk of complication, and may be elected by patients and providers for other reasons, such as local test availability or quality and patient preference.
USPSTF recommendations – With respect to these procedures, the USPSTF notes that “follow-up of positive screening test results requires colonoscopy regardless of the screening test used” (emphasis added).19 This is because a positive FOBT indicates the possible presence of a cancer or adenomatous polyp, but the screening process is not complete until the patient undergoes a colonoscopy to determine if the initial test was a true or false positive.
Insurers have adopted different approaches regarding cost-sharing for a screening colonoscopy following a positive FOBT. They vary based on whether the colonoscopy is considered part of the colorectal screening exam, or a separate, diagnostic procedure.
Screening continuum – According to medical experts, cancer screening may be best understood as a stepwise continuum that typically begins with a clinician’s recommendation that an individual without symptoms get tested and concludes with the outcome of the test(s). As one put it, “screening is not a single test, but rather a cascade of events.”20 The USPSTF recommendations are consistent with this notion, writing that “[c]olonoscopy is a necessary step in any screening program that reduces mortality from colorectal cancer” (emphasis added).21
This suggests that follow-up colonoscopy after a positive FOBT is integral to the screening process and a necessary component of screening. The 2008 Joint Guidelines issued by the American Cancer Society, the United States Multisociety Task Force on Colorectal Cancer (ACS/MSTF) and the American College of Radiology reinforce the importance of the screening continuum by emphasizing that patients with a positive FOBT need follow-up colonoscopy.22 From a prevention perspective, a screening test would not be considered successful if the follow-up colonoscopy were not performed to identify cancer and/or remove polyps that may have caused the positive FOBT in the first place.
Not all providers or insurers subscribe to this concept of the screening continuum. Some regard colonoscopy as a diagnostic service if it follows a positive FOBT. In their view the patient seeking the colonoscopy is no longer asymptomatic; the blood in the stool test (even though the patient was not aware of it before the test) is a sign that additional testing is needed. Interestingly, however, the FOBT can sometimes yield a false positive reading, and a follow-up colonoscopy would show normal results. In such cases, the health plan might apply cost-sharing to the follow-up colonoscopy which would have been free of cost-sharing had the patient chosen colonoscopy in the first place.
Insurer payment practices vary – Four insurers reported that they do not impose cost-sharing for a colonoscopy following a positive FOBT, while three insurers always impose cost-sharing. Despite believing that a follow-up colonoscopy would be diagnostic, one medical director noted that his company does not match screenings to positive lab tests so, in practice, the patient might avoid cost-sharing if the doctor codes it as a screening procedure.
A colonoscopy is a screening test for colon cancer. It is recommended that people of average risk get a colonoscopy or other type of screening every 10 years starting at age 50. People at high risk should begin screening earlier, and sometimes more often, according to the American Cancer Society .
For those not covered by health insurance, the cost of colonoscopy varies by provider and geographic region, usually ranging from $2,010 to $3,764, with an average of $3,081, according to Blue Cross Blue Shield of North Carolina.
A colonoscopy often is covered by health insurance if the patient has symptoms that warrant it or if the patient meets age and risk criteria. According to the 2012 Colorectal Cancer Legislation Report Card , 31 states have laws mandating colonoscopy coverage.
For patients covered by health insurance, out-of-pocket costs can range from zero to more than $1,000, depending on deductibles, copay and coinsurance amounts. For example, a Medicare patient at Dartmouth-Hitchcock Medical Center would pay $1,477, including deductibles and coinsurance. However, some insurance plans, such as the Blue Cross Blue Shield of Michigan Community Blue PPO plan, cover "wellness" screenings 100 percent, with no deductible or copay, usually with some restrictions
What should be included:
During the procedure, the patient is sedated, then the doctor uses a flexible tube with a camera and light on it -- a colonoscope -- to examine the rectum and inside the full length of the colon.
If anything suspicious is found, the doctor can take a sample for biopsy.
The American Gastroenterological Association has an overview of the procedure.
The American Academy of Family Physicians has a primer on colorectal cancer screening.
If polyps need to be removed during the procedure, the cost increases.
A new procedure called "virtual colonoscopy," an X-ray test that checks for colon cancer, is available. However, it is more expensive and does not detect very small polyps as reliably as a conventional colonoscopy. It is not yet considered an equal alternative to the colonoscopy.
Some government programs, hospitals and organizations provide free or low-cost screening colonoscopy for uninsured or underinsured individuals. For example, these programs provide services in New York City .
Flexible sigmoidoscopy, which does not require sedation and can be performed in a doctor's office in 20 minutes or less, costs about $100 to $300, with an average of $200, according to The Kentucky Cancer Consortium and the Action Plan on Colorectal Cancer for the State of Texas. However, it can cost significantly more -- up to about $1,500 if performed in a hospital, which would charge a facility fee. The disadvantage of flexible sigmoidoscopy is that the doctor only is able to view half of the colon, and it is recommended every five years instead of every 10. Studies have shown that the colonoscopy can detect cancers and pre-cancerous lesions that sigmoidoscopy cannot; however, cost and invasiveness make colonoscopy impractical for some.
Shopping for a colonoscopy:
If you have a regular doctor, ask for a referral to a gastroenterologist. Otherwise, a gastroenterologist should be board certified in internal medicine by the American Board of Internal Medicine and should have at least an additional two to three years of training on the GI tract.
Risk factors for colon cancer include being over 50, a family history of the disease and a personal history of inflammatory bowel disease, according to the American Cancer Society .
The most common side effect of a colonoscopy is cramping and discomfort. Rarely, complications such as perforation of the bowel, requiring surgical repair, can occur.