REDWOOD CITY, Calif., Sept. 10 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced results from three studies that support the use of quantitative real-time polymerase chain reaction (RT-PCR), as performed in the Oncotype DX assay, for measuring the hormone receptors, estrogen receptor (ER) and progesterone receptor (PR) in early breast cancer patients. A separate study identified multiple genes, including the 21 genes in Oncotype DX, that may predict the risk of breast cancer recurrence following adjuvant chemotherapy. These data were presented at the 2007 ASCO Breast Cancer Symposium that took place in San Francisco, California on September 7 and 8.
“We’re pleased to participate in ASCO’s inaugural forum dedicated to cutting-edge scientific research in breast cancer,” said Steven Shak, M.D., chief medical officer of Genomic Health. “We believe the consistent results seen in both the Kaiser Permanente and ECOG studies indicate that quantitative RT-PCR is a reliable method for determining hormone receptor status in breast cancer.”
Following are details for each study presented at the meeting: -- Abstract #88 Poster presentation: A Kaiser-Permanente Population-Based Study of ER and PR Expression by the Standard Method, Immunohistochemistry (IHC), Compared to a New Method, Quantitative Reverse Polymerase Chain Reaction (RT-PCR) Presenter: Frederick L. Baehner, M.D. Summary: A comparison of IHC, the methodology that is routinely used, to quantitative RT-PCR by Oncotype DX demonstrated a high degree of agreement in the assessment of estrogen receptor (ER), progesterone receptor (PR) and hormone (HR) status. -- Abstract #87 Poster presentation: ER and PR Assessment in ECOG 2197; Comparison of Locally Determined IHC with Centrally Determined IHC and Quantitative RT-PCR Presenter: Sunil S. Badve, M.D. Summary: A comparison of IHC and quantitative RT-PCR by Oncotype DX demonstrated a high degree of agreement for measuring ER, PR and HR status. -- Abstract #106 Poster presentation: Use of Estrogen Receptor (ER) Expression by Quantitative RT-PCR to Identify an ER Negative Subgroup by IHC Who Might Benefit from Hormonal Therapy Presenter: Luca Gianni, M.D. Summary: Independent investigators compared quantitative RT-PCR by Oncotype DX, DNA microarrays, and IHC for measuring ER status. -- Abstract #27 Oral presentation: Association of Individual Genes with Risk of Relapse in Operable Breast Cancer: Analysis of E2197 Presenter: Joseph Sparano, M.D. Summary: Further examination of the Eastern Cooperative Oncology Group E2197 study identifies multiple genes, including the 21 in Oncotype DX, that affect the recurrence risk following chemotherapy treatment.
About Oncotype DX(TM)
Oncotype DX represents the first diagnostic multi-gene expression test service 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. Oncotype DX 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 and a chemotherapy benefit study published in the Journal of Clinical Oncology. To date, over 6,000 physicians have ordered a cumulative total of more than 33,000 tests and approximately 145 million lives are now covered by reimbursement contracts and agreements. For more information about Oncotype DX, please visit http://www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. is a life science company focused on the development and commercialization of genomic-based clinical laboratory services 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 the likelihood of chemotherapy benefit in a large portion of early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit http://www.genomichealth.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the enhanced clinical value of our test and the use of RT-PCR to measure hormone receptor status. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to the risks and uncertainties associated with the regulation of our test services by FDA; our ability to develop and commercialize new test services or enhancements; unanticipated costs or delays in research and development efforts; the results of clinical studies and the other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: Genomic Health, 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: media, Emily Faucette, +1-650-569-2824, media@genomichealth.com,or investors, Brad Cole, +1-650-569-2281 investors@genomichealth.com, bothof Genomic Health, Inc.
