88% Sensitivity Reported for Stool DNA Colorectal Cancer Screening Technology in Abstract Presented at 2006 DDW Conference
[88% is far from perfect, but it is better than not being screened at all.]
Monday May 22, 7:00 am ET
Next Generation Technology Marks Milestone for Non-Invasive DNA Screening for Colon Cancer
LOS ANGELES--(BUSINESS WIRE)--May 22, 2006--EXACT Sciences Corporation (NASDAQ: EXAS - News) announced today that the results of a research study on next generation stool DNA testing technology were presented at the annual Digestive Disease Week (DDW) conference, the world's largest meeting of gastroenterology professionals. Using a simplified panel of markers and a new buffer and DNA capture technology, EXACT's stool DNA technology demonstrated an 88% sensitivity for cancer, with a specificity of 82%. The data were presented on Sunday, May 21st at the Los Angeles Convention Center.
The prospective, multi-center study, described in an abstract entitled "Improved Performance of a Non-Invasive Fecal DNA (fDNA) Test to Screen for Colorectal Cancer (CRC)," enrolled 40 individuals with CRC and 122 individuals with normal colonoscopies, none of whom had a personal or family history of polyps or CRC.
"Colonoscopy is the gold standard for colorectal cancer screening and is usually our first screening recommendation to patients," commented Dr. Steven Itzkowitz, Professor and Associate Chief, Division of Gastroenterology, Mount Sinai School of Medicine, and principal investigator of the study. "However, many people are reluctant to undergo a colonoscopy. This study shows that very high sensitivity can be achieved with non-invasive, stool DNA testing. This form of testing offers an important screening option to patients who are unwilling or unable to undergo colonoscopy."
"Colon cancer continues to be a major killer in the US with too few people getting screened, creating both a major medical challenge and a significant market opportunity for a non-invasive screening approach," added Don Hardison, President and Chief Executive Officer, EXACT Sciences. "To increase CRC screening rates and drive down mortality, accurate, non-invasive options must be offered to physicians and endorsed by their major medical societies."
"Through more than a decade of research and development, and reporting in the scientific literature, it is gratifying that stool DNA testing continues to offer great promise to the unscreened population. We believe this study represents a scientific milestone for us. With sensitivity for colorectal cancer approaching 90%, we believe that stool DNA testing and colonoscopy could be a powerful one-two punch in the quest to get more people screened and to reduce colon cancer mortality."
About Colon Cancer
Colorectal cancer - cancer of the large bowel (i.e., the colon and rectum) - is the second leading cause of cancer death each year in the U.S, behind only lung cancer. Over 150,000 people are diagnosed with CRC annually in the U.S., and nearly 60,000 individuals die from this disease each year.
The five-year survival rate associated with CRC is as high as 90% if the disease is detected in its early stages. The American Cancer Society recommends that all people over the age of 50 years be screened regularly for the disease. (That represents more than 80 million people in the U.S). Unfortunately, less than 40% of those over age 50 years have ever been screened, let alone as frequently as recommended. CRC screening rates are lower than those for breast and cervical cancer in women, and lower than that for prostate cancer in men. As a consequence, two-thirds of CRC cases are detected in later, less treatable stages.
About EXACT Sciences Corporation
EXACT Sciences Corporation uses applied genomics to develop effective, patient-friendly screening technologies for use in the detection of cancer. Certain of its technologies have been licensed to Laboratory Corporation of America Holdings (LabCorp) for a stool-based DNA screening assay for colorectal cancer in the average-risk population. Colorectal cancer, which is the most deadly cancer among non-smokers, is generally curable if detected early. Despite the availability of colorectal cancer screening and diagnostic tests for more than 20 years, the rate of early detection of colorectal cancer remains low, and deaths from colorectal cancer remain high. EXACT Sciences believes its genomics-based technologies will help enable detection of colorectal cancer so that more people can be effectively treated. Founded in 1995, EXACT Sciences is based in Marlborough, Mass. PreGen-Plus(TM) has not been approved or cleared by the Food & Drug Administration.
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