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Exact Sciences Announces FDA Advisory Committee Unanimously Recommends Approval of Cologuard
First of its Kind Stool-based DNA Screening Test for Colorectal Cancer
MADISON, Wis., March 27, 2014 – Exact Sciences Corp. (Nasdaq: EXAS) today announced that the U.S. Food and Drug Administration's (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee determined by a unanimous vote of 10 to zero that Exact Sciences has demonstrated safety, effectiveness and a favorable risk benefit profile of Cologuard ®, the company's stool-based DNA (sDNA), non-invasive colorectal cancer screening test.
"We are pleased the Committee strongly supported Cologuard's approval," said Kevin T. Conroy, chairman and chief executive of Exact Sciences. "We look forward to continuing our work with the FDA to complete its review of Cologuard and remain committed to addressing the growing unmet needs in colorectal cancer screening. We thank the FDA and its advisory committee for its careful consideration of Cologuard. We also appreciate the opportunity to participate in the innovative FDA/CMS parallel review program. "
In the company's 10,000-patient, 90-site DeeP-C pivotal trial—one of the most extensive colorectal cancer screening studies ever conducted in the United States—Exact Sciences' Cologuard found 92.3% of colorectal cancer in average risk patients based on a combination of DNA and hemoglobin markers. Exact Sciences submitted the final module of its PMA for Cologuard on June 7, 2013, and the application includes data from that study, which was published online on March 19, 2014, in the New England Journal of Medicine. The peer-reviewed study, "Multi-target Stool DNA Testing for Colorectal-Cancer Screening" will also appear in the journal's April 3, 2014 print issue.
The FDA is not bound by the recommendation of its advisory committee, but will consider the committee's guidance as it evaluates the Cologuard PMA.
Exact Sciences’ DeeP-C Study Results Published in New England Journal of Medicine
Non-invasive, Stool-based DNA Test Shown to Detect 92% of People with Colorectal Cancer compared to 74% for the Fecal Immunochemical Test (FIT)
MADISON, Wis., March 19, 2014 – Exact Sciences Corp. (Nasdaq: EXAS) today announced that results from its DeeP-C pivotal clinical study have been published online in the New England Journal of Medicine. The peer-reviewed study, “Multi-target Stool DNA Testing for Colorectal-Cancer Screening” will also appear in the journal’s April 3, 2014 print issue.
The 10,000-patient DeeP-C study was designed to determine the performance characteristics of Exact Sciences’ multi-target stool DNA-based screening test, Cologuard ®, for colorectal cancer and to compare that performance to the fecal immunochemical test (FIT), a commonly used non-invasive colorectal cancer screening test. The DeeP-C study took place at 90 centers throughout the U.S. and Canada.
The DeeP-C data published in the NEJM elaborate on top-line data Exact Sciences announced in April of 2013. Data published today include:
- Sensitivity of Cologuard in detecting patients with colorectal cancer was 92% versus 74% for FIT;
- Sensitivity in detecting patients with colorectal cancers in Stages I-III —those determined by the American Joint Committee on Cancer to be associated with an increased rate of being cured—was 93% for Cologuard versus 73 % for FIT;
- Sensitivity for patients with advanced pre-cancerous lesions was 42% for Cologuard versus 24% for FIT;
- Cologuard detected 69% of patients with polyps with high-grade dysplasia versus 46% for FIT;
- Cologuard achieved a specificity of 87% versus FIT specificity of 95%.
Colorectal cancer is often considered the most preventable, yet least prevented cancer. One out of 3 adults age 50 and older has not been screened as recommended and, as a result, colorectal cancer remains the second-leading cancer killer in the United States. Colorectal cancer is highly treatable if found early, making the detection of pre-cancerous polyps paramount.
“We know that colorectal cancer can be prevented and can be highly treatable if found early through screening” said lead author Thomas F. Imperiale M.D., of the Indiana University School of Medicine, Regenstrief Institute Inc., the IU Simon Cancer Center, and the Roudebush VA Medical Center in Indianapolis. “Sensitivity is the most important characteristic for screening tests because the primary role of such testing is to rule out diseases such as cancer. In our clinical study, the data show that Cologuard, the multi-target stool-based DNA test, is highly sensitive in detecting colorectal cancer and higher risk pre-cancerous polyps in a large, diverse average-risk patient population and has the potential to be an important screening tool.”
“We are very pleased with the data published today in the New England Journal of Medicine,” said Kevin T. Conroy, president and chief executive of Exact Sciences. “We believe Cologuard could be an important tool in the early detection of colorectal cancer. This is an important milestone for Exact Sciences and Cologuard.” The Exact Sciences Cologuard screening test is an investigational device currently under review by the U.S. Food and Drug Administration (FDA) and is not available for sale in the United States. The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to review Exact Science’s PMA application for Cologuard on March 27, 2014.
About Cologuard, Exact Sciences’ Investigational Stool-based DNA Screening Test
Every day, millions of normal cells are shed from the colon lining into the stool stream. As these cells degenerate, they release DNA. All colon cancers start as precancerous lesions, commonly called polyps, and as those polyps develop, they also shed cells into the stool stream. Some of these cells contain altered DNA, reflecting acquired mutations and methylation found in pre-cancerous polyps and cancer. Cologuard is designed to have patients collect a stool sample at home and send it to a lab where the sample will be processed through a series of sophisticated laboratory procedures to isolate specific DNA targets. The targeted DNA is then amplified and analyzed for molecular alterations associated with cancerous and pre-cancerous conditions of the colon and rectum. Doctors will discuss results with their patients. If the Cologuard result is positive, patients should be referred for a diagnostic colonoscopy. While the science behind stool-based DNA screening is complex, the specimen collection process is easy, requiring no bowel preparation and no dietary restrictions.
Kevin Conroy, President & CEO
Stool-Based DNA Screening for Colorectal Cancer
Exact Sciences and the NCCRT share the goal of increasing colorectal cancer screening. Contact www.nccrt.org for more information.