SAN ANTONIO, Dec. 10 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced positive results from a new analysis demonstrating that the same Oncotype DX(TM) Recurrence Score(TM) that quantifies distant recurrence for a large portion of early-stage breast cancer patients is also a significant predictor of local or regional recurrence in tamoxifen-treated patients. This study, conducted by researchers from the National Surgical Adjuvant Breast and Bowel Project (NSABP) -- a National Cancer Institute-funded cooperative group, Genomic Health and the Aultman Health Foundation, was presented at the 28th Annual San Antonio Breast Cancer Symposium.
“Our analysis suggests an important correlation between an individual patient’s Recurrence Score and time to first local or regional recurrence,” said Terry Mamounas, M.D., chair of the NSABP Breast Committee, medical director, Aultman Cancer Center, and lead author of the study. “These results expand the predictive value of Oncotype DX and could have clinical implications for the individualizing of loco-regional therapy decisions.”
This analysis of 1,674 patients from previous NSABP B-14 and B-20 randomized clinical trials (895 tamoxifen-treated patients, 355 placebo-treated patients and 424 chemotherapy plus tamoxifen-treated patients) demonstrated a clear association between the Recurrence Scores as identified by Oncotype DX and risk for loco-regional recurrence (LRR). Specifically, the study found the Recurrence Score to be a significant predictor of LRR among the 895 tamoxifen-treated patients with lymph node-negative (N-), estrogen receptor-positive (ER+) breast cancer (p-value < 0.00001), independent of age, clinical tumor size and tumor grade. Significant associations of the Recurrence Score and LRR were also observed in the placebo-treated and chemotherapy plus tamoxifen-treated patients (p-value < 0.05).
Separately, researchers from Genomic Health and the Royal Marsden Hospital in London also reported that successful gene expression analysis from very small fixed paraffin-embedded tumor specimens was feasible using the Oncotype DX 21-gene panel. In this study the standard Oncotype DX 21-gene test was performed on tumor specimens using both unamplified RNA and amplified RNA. Overall, gene expression profiles and Recurrence Scores obtained using amplified RNA were similar to those obtained with unamplified RNA. These results indicate that Genomic Health can perform quantitative gene expression analysis for clinical studies by amplifying RNA with 50 - 100 fold less tissue than typically used in the standard test.
“These findings suggest that our Oncotype test can provide robust results on even very small tumor specimens,” said Joffre Baker, Ph.D., chief scientific officer for Genomic Health. “This is important because for many studies that analyze archived specimens, only limited amounts of tumor tissue are available. This information gives us the confidence to work with smaller tissue samples.”
“We are encouraged by these findings and excited about the possibility of using this technology in upcoming clinical trials as we begin to look at the Recurrence Score’s correlation with prognosis and treatment benefit with aromatase inhibitors,” said Mitch Dowsett, Ph.D., Royal Marsden Hospital in London.
Yesterday, Genomic Health also presented findings from a 68-patient independent community-based study demonstrating that the Oncotype DX breast cancer test changed the choice of adjuvant therapy in 25% of patients with early-stage breast cancer.
The 28th annual San Antonio Breast Cancer Symposium is being held at the Henry B. Gonzalez Convention Center in San Antonio, Texas, from December 8-11, 2005. For more information, visit www.sabcs.org.
About Oncotype DX
Oncotype DX represents the first diagnostic multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit. The test has been extensively evaluated in multiple independent studies involving more than 2,600 breast cancer patients, including a large validation study published in The New England Journal of Medicine. For more information about Oncotype DX, please visit www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. is a life science company focused on the development and commercialization of genomic-based clinical diagnostic tests for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched its first test, Oncotype DX(TM), which has been shown to predict the likelihood of breast cancer recurrence and chemotherapy benefit in early stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the expansion of the predictive value of our test, the potential clinical implications regarding therapy decisions, the ability of our test to use smaller tissue specimens, possible future uses of our technology and the applicability of clinical study results to actual outcomes. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, which is on file with the Securities and Exchange Commission and is available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
Genomic Health, Inc.
CONTACT: Emily Faucette, +1-415-595-9407, or Emily@weisscommpartners.com;or Katie Compa, +1-646-644-1567, or kcompa@weisscommpartners.com, both ofWeissComm Partners, for Genomic Health; or Brad Cole of Genomic Health,+1-650-569-2281, or investors@genomichealth.com
