Study Published in the Journal of Clinical Oncology Proves Accurate Measurement of ER and PR Status Using Quantitative Reverse-Transcriptase
Polymerase Chain Reaction (RT-PCR)
REDWOOD CITY, Calif., June 2 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that the Journal of Clinical Oncology (JCO) published results of a study confirming RT-PCR by Oncotype DX can deliver quantitative gene expression levels for assessing estrogen receptor (ER) and progesterone receptor (PR) status, which are critical factors in determining the use and benefit of hormonal therapy for the treatment of breast cancer. Based on these results, Genomic Health is now providing quantitative ER and PR scores to physicians and patients in addition to the Recurrence Score(TM) result provided in the Oncotype DX(R) report.
Unlike traditional methodologies that provide either a positive or negative result, or a semi-quantitative result, RT-PCR by Oncotype DX generates a specific score across a continuous range of expression which allows physicians to factor the quantitative level of ER and PR gene expression into their treatment planning.
"Every breast tumor expresses the estrogen receptor gene at a specific level and, similar to other diagnostic measures, the ability to more accurately pinpoint that level increases the confidence in a diagnosis and treatment plan," said Sandra Swain, M.D., Medical Director, Washington Cancer Institute, Washington Hospital Center. "Having quantitative ER and PR scores provides added certainty in confirming expression levels of these important genes in predicting how likely a patient is to benefit from hormonal therapy."
This study published in JCO was originally presented at the American Society of Clinical Oncology Breast Cancer Symposium in September 2007. It measured ER and PR gene expression in 776 breast cancer patients by both local laboratory and central immunohistochemistry (IHC), and quantitative RT-PCR, as performed by the Oncotype DX assay. Results showed a high degree of agreement between the two methods. In an accompanying editorial, Dr. Craig Allred comments, "RT-PCR is at least equivalent to IHC in its ability to identify receptor-positive cases (considering ER and PR combined), marginally superior in predicting outcome in ER-positive patients, and superior in technical precision."
"We believe the methodology of the future is the quantitative measure of the biology of each individual tumor," said Steven Shak, M.D., chief medical officer of Genomic Health. "Providing physicians with quantitative ER and PR scores enhances the value of Oncotype DX by providing more patient-specific information to help individualize treatment decisions for breast cancer patients. We are continuing to conduct additional studies, including studying the use of RT-PCR by Oncotype DX to quantify HER-2 gene expression, another cancer-related gene that plays an important role in the determination of optimal treatment for breast cancer patients."
About Oncotype DX(R)
Oncotype DX is the first and only multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. Oncotype DX has been extensively evaluated in multiple independent studies involving more than 3,600 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, 7,500 physicians have ordered more than 55,000 tests, and health plans covering over 80 percent of U.S. insured lives provide reimbursement for Oncotype DX through contracts, agreements and policy decisions. Both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network recommend the use of Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive. For more information about Oncotype DX, please visit http://www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. (Nasdaq: GHDX) 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(R), which has been shown to predict the likelihood chemotherapy benefit as well as recurrence in 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 company's belief that the quantitative measurement of individual tumor biology is the methodology of the future and the belief that providing quantitative ER and PR scores enhances the value of Oncotype DX. These risks and uncertainties include, but are not limited to: the results of additional clinical studies; the risk that we may not obtain sufficient levels of reimbursement for any future tests we may develop; our ability to develop and commercialize new products; the risks and uncertainties associated with the regulation of our tests by FDA; our ability to obtain capital when needed; our history of operating losses 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 three-month period ended March 31, 2008. 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.
|SOURCE Genomic Health, Inc.|
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