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Genomic Health – Oncotype DX Colon - 2nd confirmatory Validation Study for Stage II Colon

Results determine 3 year recurrence for stage II colon cancer.   The assay reveals the biology of the tumor (T3) indicates which are more similar to T4 Disease. The Oncotype DX colon cancer test was made available in 2010 based on results from the QUASAR study, allowing physicians to go beyond the limited set of clinical and pathologic markers to make more informed decisions about the adjuvant use of chemotherapy for stage II colon cancer based on the quantitative individualized assessment of recurrence risk," said Steven Shak, M.D., chief medical officer at Genomic Health. "These results, together with the positive confirmatory clinical study presented by the CALGB at ASCO in June and Medicare's recent coverage announcement pave the way for expanded reimbursement and increased patient access to the Oncotype DX colon cancer test."

The QUASAR clinical validation study analyzed 1,436 patients with stage II colon cancer. http://investor.genomichealth.com/releasedetail.cfm?ReleaseID=621739.


Genomic Health launched an Oncotype DX DCIS Test in January 2012.

This is a multigene assay that can accurately quantify a woman’s risk of recurrence prior to radiation therapy. The assay was validated on patients from ECOG 5194 Study.

The study, presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score goes beyond traditional clinical and pathologic measures to predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.

Understanding the biological risk will better determine the risk and help patients and clinician’s weight the treatment options. http://investor.genomichealth.com/releasedetail.cfm?ReleaseID=630902.