Public Release:  New test measures DNA methylation levels to predict colon cancer

American Association for Cancer Research

PHILADELPHIA -- An investigational DNA methylation test could alter the screening landscape for colorectal cancer, according to data presented at the American Association for Cancer Research special conference on Colorectal Cancer: Biology to Therapy, held here Oct. 27-30, 2010.

Colorectal cancer is the third leading cause of cancer, and the second leading cause of cancer mortality. While celebrities continue to undergo public colonoscopies in an effort to increase awareness, only 60 percent of adults age 50 and older have undergone recommended screening, according to the Centers for Disease Control and Prevention.

David Ahlquist, M.D., professor of medicine and a consultant in gastroenterology at the Mayo Clinic in Rochester, said much of that low rate may be due to inconveniences associated with conventional approaches.

"There is definitely an incentive and legitimate justification to be designing a screening approach that is user friendly, affordable and has the ability to detect pre-cancers," said Ahlquist. "The noninvasive stool DNA test we have developed is simple for patients, involves no diet or medication restriction, no unpleasant bowel preparation, and no lost work time, as it can be done from home. Positive tests results would be followed up with colonoscopy."

The test that Ahlquist and colleagues evaluated is under development by Exact Sciences, a molecular diagnostics company in Wisconsin.

The test, which is not yet approved by the FDA, is conducted using a stool sample and works by detecting tumor-specific DNA alterations in cells that are shed into the stool from pre-cancerous or cancerous lesions.

In this first clinical validation study presented at the AACR conference, which included 1,100 patients, the researchers detected 64 percent of precancerous adenomas greater than 1 cm and 85 percent of cancers. Polyps over 1 cm are considered the most likely to progress. Furthermore, cancers and precancerous adenomas were detected equally well on both sides of the colon.

Colorectal cancer rate detection was 87 percent for cancers considered to be in the most curable stage (stage I-III) and 69 percent for the most advanced stage (stage IV).

Further clinical trials are planned for next year, according to Exact Sciences.

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Under an exclusive license agreement with Mayo, Exact has rights to intellectual property developed by Ahlquist and Mayo Clinic. Exact will make up-front, milestone and royalty payments to Mayo Clinic, which will be shared with Ahlquist in accordance with Mayo Clinic's Royalty Sharing Policy and will also provide funding for future work in Ahlquist's lab.

The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, the AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes 32,000 basic, translational and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 90 other countries. The AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants, research fellowships and career development awards. The AACR Annual Meeting attracts more than 18,000 participants who share the latest discoveries and developments in the field. Special conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment and patient care. The AACR publishes six major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; Cancer Epidemiology, Biomarkers & Prevention; and Cancer Prevention Research. The AACR also publishes CR, a magazine for cancer survivors and their families, patient advocates, physicians and scientists, providing a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship and advocacy.

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