Non-invasive stool-based screening test detects 64% of colorectal pre-cancers

Exact Sciences (Nasdaq: EXAS) today presented data showing that its non-invasive Cologuard^TM stool-based (sDNA) screening test detected 64 percent of colorectal pre-cancers and 85 percent of cancers. The study was conducted in collaboration with Mayo Clinic and examined more than 1,100 patient samples. Results were presented at the 2010 Special Conference for Colorectal Cancer: Biology to Therapy held by the American Association for Cancer Research in Philadelphia, PA.

“Colorectal cancer is a treatable disease if caught early, and this test shows great promise as a potential addition to other available screening tools.”

Colorectal cancer is the second leading cancer killer in the United States. It often is considered the most preventable, yet least prevented cancer. Colorectal cancer is highly treatable if found early, but 40 percent of adults age 50 and older have not been screened as recommended.

"This is the first study of an sDNA test to show such promising results in detecting colorectal pre-cancer," said lead investigator David A. Ahlquist, M.D., Mayo Clinic, Rochester, Minn. "Colorectal cancer is a treatable disease if caught early, and this test shows great promise as a potential addition to other available screening tools."

The latest American Cancer Society colorectal cancer screening guidelines include the sDNA form of testing as a recommended screening option. The Cologuard sDNA test works by detecting specific altered DNA sequences in cells that are shed into the stool from pre-cancerous or cancerous polyps. If a DNA abnormality is identified from a patient's sample, a colonoscopy is required to confirm the results.

Findings from the more than 1,100-patient study showed that Cologuard detected 64 percent of adenomas, or polyps, greater than 1 centimeter (cm) and 85 percent of cancer, at a specificity of 88 percent. Polyps over 1 cm are considered the pre-cancers most likely to progress to cancer. Detection rates did not vary by patients' age or sex, or by cancer location.

"We are excited about these encouraging results for Cologuard, which may offer an important step in the early detection of this terrible disease," said Kevin T. Conroy, president and chief executive of Exact Sciences.

Cologuard is an investigational device and is not available for sale in the United States. The company plans to begin clinical trials next year.