SOURCE: Genomic Health

Genomic Health

May 03, 2010 08:15 ET

Genomic Health Announces New Data Reporting Clinical Usage Patterns of Oncotype DX® Among Breast Surgeons and Medical Oncologists

Additional Research Indicates It Is Feasible to Obtain Oncotype DX Recurrence Score® Results in Ductal Carcinoma In Situ (DCIS) of the Breast

REDWOOD CITY, CA--(Marketwire - May 3, 2010) -  Genomic Health, Inc. (NASDAQ: GHDX) today announced results from a study which found that results of the Oncotype DX® breast cancer test are available sooner in the treatment decision making process when breast surgeons order the test. The study, presented last week at the American Society of Breast Surgeons (ASBS) 11th Annual Meeting, is also the first to compare patient demographics and Recurrence Score® results when the Oncotype DX breast cancer test is ordered by breast surgeons and medical oncologists.

Oncotype DX measures the expression of 21 genes of an individual tumor to generate a Recurrence Score (RS) result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for patients with estrogen receptor positive, early-stage breast cancer. The time from the initial breast cancer surgery to final Oncotype DX report delivery was, on average, about two weeks shorter when surgeons ordered the test compared to when medical oncologists ordered the test.

"Most patients don't grasp the concept of adjuvant therapy at the time they are making surgical decisions. At our center, surgeons, medical oncologists, and radiation oncologists meet weekly to discuss new breast cancer diagnoses. If indicated from the core biopsy results, our nurse coordinator submits the tumor specimen for Oncotype DX testing," said Douglas Yee, M.D, director Masonic Cancer Center, University of Minnesota. "Having a patient's Recurrence Score at the time of the first consultation with the medical oncologist can lead to more meaningful conversation about treatment options."

In addition, this study reported that patient demographics, such as age and nodal status, were similar for the tests ordered by breast surgeons and medical oncologists. The distribution of RS results was also consistent across tests ordered by breast surgeons and medical oncologists.

Oncotype DX Recurrence Score Genes Could Provide Important Information to DCIS Patient Population
A separate study, presented last month at the 27th Annual Miami Breast Cancer Conference, demonstrated that ribonucleic acid (RNA extraction) and reverse transcription polymerase chain reaction (RT-PCR) technology, which are part of the Oncotype DX test, can be successfully performed to assess gene expression profiles from formalin fixed paraffin embedded Ductal Carcinoma In Situ (DCIS) patient samples.

DCIS is a premalignant form of breast cancer and there were an estimated 45,000 cases reported in the U.S. in 2009. Patients diagnosed with DCIS have an increased risk of recurrent DCIS as well as invasive breast carcinoma.

This study successfully studied 17 enriched DCIS patient samples and demonstrated a wide range of RS results (range 1-56). The distribution of RS results included nine (53 percent) with a low RS, four (24 percent) with an intermediate RS and four (24 percent) with a high RS, comparable to the distribution of RS seen in early stage invasive breast cancer.

"Despite a low risk for recurrence or progression to invasive cancer, many DCIS patients undergo intensive treatment including radiation and hormonal therapy," said Steven Shak, MD, chief medical officer, Genomic Health. "This study suggests the Oncotype DX breast cancer test can be performed in DCIS, and we look forward to conducting clinical studies to evaluate the clinical utility of quantitative gene expression in this important patient population."

About the Studies
The comparative analysis, presented at the ASBS meeting, reviewed 34,317 tumor samples submitted by medical oncologists and 9,762 samples submitted by surgeons over a year. The distribution of RS results was comparable for both medical specialties, with 55 percent low risk, 32 percent intermediate risk and 12 percent high risk. Of note, the time from surgery to RS report generation was notably different between groups. On average, the ordering physician received the RS results 35 days from surgery (median 26 days) when surgeons ordered the test compared to 51 days (median 40 days) when ordered by medical oncologists.

The study presented at the Miami Breast Cancer Conference analyzed 20 DCIS specimens from Kaiser Permanente Northern California and utilized manual microdissection to enrich DCIS tumor tissue. RNA was extracted from DCIS samples and the Oncotype DX genes were assessed using quantitative RT-PCR. Three enriched tumor samples had insufficient RNA and were excluded from extended analyses. Of the remaining 17 samples, the median RNA yield was sufficient to provide analysis of the Recurrence Score, including estrogen receptor (ER), progesterone receptor (PR), and HER2 status. This study showed that RNA can be extracted and the Oncotype DX breast cancer test genes quantitated from fixed paraffin embedded DCIS patient samples.

About Oncotype DX®
The Oncotype DX breast cancer test is a commercially available multigene expression test that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. Additionally, the test report provides quantitative scores for certain individual genes. The Oncotype DX breast cancer test has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, 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. As of December 2009, more than 8,000 physicians in over 55 countries had ordered more than 135,000 tests, and both Medicare and private health plans covering over 90 percent of U.S. insured lives provided reimbursement for Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive through contracts, agreements or policy decisions. Both the American Society of Clinical Oncology 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 www.oncotypedx.com.

About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a life science company focused on the global 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 the Oncotype DX® breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health launched its Oncotype DX colon cancer test in January 2010. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit 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 belief that the study data support the clinical utility of our test in Ductal Carcinoma In Situ breast cancer patients, the belief that using Oncotype DX for breast cancer can allow better-informed decisions , the belief that the timing of test results is important to treatment decisions, our expectations regarding conducting additional clinical studies to evaluate the utility of our test in patients with DCIS, 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, 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 the company's tests; the applicability of clinical study results to actual outcomes; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Annual Report on Form 10-K for the year ended December 31, 2009. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims 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.

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