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First and only stool DNA test featuring non-invasive sample collection in the privacy of the patient’s home

Exact Sciences Corp. (Exact Sciences) (NASDAQ: EXAS) has announced that Cologuard, the first and only non-invasive DNA colorectal cancer screening test, is now CE marked and available for sale in the United Kingdom.

Cologuard offers people 50 years of age or older (at average risk of colorectal cancer) an easy to use screening test, the sample for which is easily collected in the privacy of their own home. Cologuard represents an innovation in non-invasive testing for colorectal cancer as it allows analysis of both stool DNA and blood biomarkers. This allows for 92% of cancers to be detected and 69% of the most advanced precancerous polyps in average risk patients with 87% specificity.

Colorectal cancer (often known as bowel cancer), is one of the most common cancers in the UK after breast and lung cancer, with approximately 40,000 new cases being registered each year. The condition is preventable in many cases, and highly treatable with a 90% chance of survival if diagnosed in the early stages. Despite this, colorectal cancer still kills 16,187 in the UK each year. 

“Colorectal cancer is highly preventable. Unfortunately, the condition is only highly preventable when detected early. For the majority of cases the cancer has already developed into the higher stages of the disease by the time of detection, making treatment more challenging.” said Professor Mike Parker, Council Member of the Royal College of Surgeons England and past President of The Association of Coloproctology of Great Britain and Ireland (ACPGBI). “Cologuard allows for a non-invasive, highly sensitive test in the comfort of your own home”

Cologuard is designed to detect both blood and biomarkers from DNA in the stool that may indicate the presence of cancer or pre-cancer. In a large prospective study, Cologuard has been shown to improve detection of cancer and pre-cancerous polyps compared to a leading immunochemical Faecal Occult Blood test (iFOBT).1 Not all polyps or lesions actively and/or constantly bleed. Cologuard is highly sensitive and detects multiple markers from cells that are exfoliated into stools continuously.

“The CE marking of Cologuard represents another major achievement in Exact Sciences’ mission to make a non-invasive, patient-friendly screening test for colorectal cancer available outside of the USA,” said Kevin Conroy, Chairman and CEO of Exact Sciences. “We are committed to advancing colon cancer screening by offering Cologuard which is designed with a high sensitivity for colorectal cancer and to be easy to use and implement.”

Results from the company’s DeeP-C Study, a prospective, 90-site, 10,000-patient point-in- time pivotal study—one of the most extensive privately funded colorectal cancer screening studies ever conducted in the U.S.—were published in April 2014 in the New England Journal of Medicine’s, “Multi-target Stool DNA Testing for Colorectal-Cancer Screening”.