A Combined Gene-Based Test for Guiding Therapy in Colon Cancer

This method employs two separate molecular screening tests: one that tests for mutation in the BRAF gene sequence (reported in colon cancer), and one that tests for microsatellite instability (MSI) among the numerous adjacent DNA base pairs that repeat in tandem up to five times. These screening tests together are used to indicate the presence of colorectal cancer and the associated five-year survival rates. If a BRAF mutation is indicated in conjunction with a microsatellite-stable cancer, the probability of five-year survival is significantly lower than a wild-type BRAF or a microsatellite-unstable cancer.
The method is appropriate for all patients with at least Stage II to Stage IV colon cancer; i.e., cancer in which the cancerous cells have begun to spread to nearby tissue or beyond.

*The mutation in BRAF is used to determine prognosis and, potentially, therapy in microsatellite stable colon cancers as well as other cancers.
*Currently BRAF and microsatellite are being offered as separate tests, but neither test alone predicts patient condition as effectively as the tests together do.
*This method unites the two tests to indicate whether an unfavorable prognosis exists, which is indicated when the method reveals a BRAF mutation and microsatellite stability.

Stage of Development
A provisional patent application has been filed with the U.S. Patent and Trademark Office. This method is part of an active and ongoing research program and is available for developmental research support and licensing under either exclusive or non-exclusive terms.

Additional Info
*Samowitz WS et al. Poor survival associated with the BRAF V600E mutation in microsatellite-stable colon cancers. Cancer Res 65(14):6063-69 (2005).
*Samowitz WS et al. Microsatellite instability in sporadic colon cancer is associated with an improved prognosis at the population level. Cancer *Epidemiology Biomarkers Prevention 10:917-23 (2001).
Dr. Samowitz�s Website: http://www.huntsmancancer.org/research/bios/samowitz.jsp

Inventor(s): Roger Wolff, Wade Samowitz, Martha Slattery

Type of Offer: Licensing

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