REDWOOD CITY, Calif., March 20, 2017 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from 15 Oncotype DX Breast Recurrence Score® studies conducted in 12 countries that provide real-world evidence of the test's ability to change treatment decisions in breast cancer patients. The new findings, presented at the 15th St. Gallen International Breast Cancer Conference in Vienna, demonstrate the economic value of the test across multiple healthcare systems and reinforce the clinical validation, accuracy and precision of the Breast Recurrence Score™ in various early-stage breast cancer patient populations, including those with node-positive disease.
"Precision medicine is no longer just a promise – it is a reality for the more than 700,000 cancer patients tested to date for whom Oncotype DX has individualized care based on the biology of their tumor," said Steven Shak, M.D., chief scientific officer, Genomic Health. "The extensive scientific evidence on the clinical and health economic value of the Oncotype DX Breast Recurrence Score is unsurpassed as evidenced by its inclusion in all major global guidelines. We look forward to the publication of the updated St. Gallen International Expert Consensus Panel report, which has recognized Oncotype DX as the leading test to guide chemotherapy decisions since 2011."
In addition, the American Joint Committee on Cancer (AJCC) recently incorporated the Oncotype DX test in its updated published Eighth Edition AJCC Cancer Staging Manual, identifying Oncotype DX as the only multi-gene test with Level I evidence to determine formal staging of breast cancer patients, based on prospective outcomes in more than 63,000 patients.
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New data presented last week at the St. Gallen International Breast Cancer Conference include:
Three studies involving more than 8,000 node-positive breast cancer patients showed those with a low Oncotype DX Breast Recurrence Score (RS) had excellent outcomes at five years
An analysis of the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute (NCI) of 6,768 patients with lymph node-positive disease (including micrometastases) found that the five-year breast cancer-specific survival (BCSS) rate was excellent for those with a RS of less than 18, particularly among those with micrometastases and fewer positive lymph nodes. Five-year BCSS outcomes for those with a RS less than 18 ranged from 98.9 percent for those with micrometastases to 92.8 percent for those with four or more positive nodes. The RS was strongly predictive of BCSS among patients with micrometastases or one to three positive lymph nodes (both p<0.001). These findings in node-positive disease were recently updated and published in Breast Cancer Research and Treatment, providing further detail on the five-year outcomes results previously published in Nature Partner Journals Breast Cancer.