It's here! Much anticipated scientific test for Stage II and III patients

Announced today, Jan. 21...

If you've been reading about this test since May 2009, when it was first presented to the American Association of Oncologists and was promised to be available in early 2010, it's finally here! Now how long will it take the NIH Comprehensive Cancer Centers, or any oncologists for that matter, to get it for their patients? --K1


REDWOOD CITY, Calif., Jan. 21 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced worldwide commercial availability of its Oncotype DX® colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. The 12-gene advanced diagnostic test is clinically validated to predict individual recurrence risk in stage II colon cancer patients following surgery, as reported at the 2009 American Society of Clinical Oncology (ASCO) meeting.

"We are pleased to deliver a new model for assessing recurrence risk in patients diagnosed with stage II colon cancer that is based on rigorous scientific research conducted with our clinical collaborators at the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Cleveland Clinic and the QUASAR study group," said Steven Shak, M.D., chief medical officer, Genomic Health. "We believe the availability of the Oncotype DX colon cancer test will allow physicians, for the first time, to go beyond the limited set of clinical and pathologic markers they currently use in order to make a more precise risk assessment in the treatment planning for stage II colon cancer patients."

Additionally, two new studies released online yesterday for presentation at the upcoming ASCO Gastrointestinal Cancers Symposium provide further support for the use of the Oncotype DX colon cancer test as an independent predictor of recurrence risk in stage II colon cancer patients. The new results also suggest a potential role for the test in patients with stage III disease pending further study.

New Data Presented at ASCO Gastrointestinal Cancers Symposium Reinforce Clinical Benefits of Oncotype DX Colon Cancer Test

The first study, which will be presented in a poster session on January 24, showed that the Oncotype DX colon cancer Recurrence Score® result and number of nodes examined are independent predictors of recurrence in stage II colon cancer and both should be considered when assessing individual recurrence risk in this patient population. The second study, to be presented in an oral discussion on January 24, analyzed various biological similarities and differences between stage II and III colon cancer. Results suggest the Oncotype DX Recurrence Score result is stage independent, and that it may also predict recurrence risk in stage III colon cancer.

"Some tumor characteristics, such as grade, and a small number of individual genes were identified that may distinguish stage II and III colon cancers. However, there is a striking similarity between the two stages for the vast majority of the 375 genes studied and for the 12-gene Oncotype DX colon cancer Recurrence Score," said Michael J. O'Connell, M.D., associate chairman of the NSABP. "As physicians begin to incorporate Oncotype DX into clinical practice for stage II colon cancer patients, it is worth conducting additional studies to evaluate this test for treatment planning in stage III disease, based on the similarities observed in this study."

Both studies used Genomic Health's quantitative RT-PCR to analyze RNA expression from 30 micrometers of manually microdissected fixed paraffin-embedded primary colon cancer tissue.

The first study utilized data from the landmark QUASAR trial to assess the prognostic value of nodal assessment in combination with other variables including the Oncotype DX Recurrence Score result. Number of nodes examined was available for 657 of 711 patients randomized to surgery alone, and was significantly associated with recurrence risk as a continuous variable, after controlling for age, T-stage, grade, lymphovascular invasion, mismatch repair and year of randomization. Both Recurrence Score and number of nodes examined were independent predictors of recurrence risk (p=0.01 and 0.05, respectively). Additionally, the study results proved consistent with the National Comprehensive Cancer Network's recommendation of 12 or more nodes examined as a target for nodal assessment.
The second study compared pathologic markers and gene expression by stage in four studies conducted to develop the Oncotype DX colon cancer test. Pathologic markers and expression of 375 genes were compared between 634 stage II and 844 stage III patients. Results demonstrated that the vast majority of the 375 genes and the Recurrence Score showed no significant interaction with stage, and there were similar patterns of gene expression by stage. However, there were differences identified between stage II and stage III colon cancer for some tumor characteristics and a small number of the individual genes. Stage II patients were more likely to be mismatch repair deficient (p=0.04) and have mucinous histology (p=0.007). Additionally, interaction of grade and stage was significant (p=0.005), and interactions of stage with T-stage, mismatch repair and mucinous histology were borderline (p=0.07 – 0.11), indicating prognostic value in stage II, but not stage III disease.


About the Oncotype DX® Colon Cancer Test

The Oncotype DX colon cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer.

Availability in New York is pending review by the state, as is required for all laboratory developed tests.

For its colon cancer program, Genomic Health and its collaborators used the same rigorous clinical development strategy and standardized quantitative technology designed for the company's Oncotype DX breast cancer test. The NSABP conducted three development studies and Cleveland Clinic conducted one development study, all of which were funded by Genomic Health, analyzing 761 genes from 1,851 patients with stage II colon cancer. The final set of seven recurrence and five reference genes were then independently evaluated in 1,436 stage II colon cancer patients in the QUASAR validation study.

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. Since 2004 Genomic Health has marketed its widely-adopted Oncotype DX breast cancer test, which is clinically validated to predict the likelihood of recurrence and chemotherapy benefit in early-stage breast cancer. As of December 2009, more than 8,000 physicians have ordered more than 135,000 Oncotype DX tests for their breast cancer patients worldwide. For more information about the Oncotype DX breast cancer test, please visit www.oncotypedx.com.

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 company's belief that the availability of its test will allow physicians to go beyond existing clinical and pathologic markers in order to make more precise risk assessments in the treatment planning for stage II colon cancer patients; the belief that clinical study results may suggest a role for the test in treatment planning for stage III colon cancer patients, and that additional research in this regard is warranted; the applicability of clinical study results to actual outcomes; the potential benefits or implications in the clinical setting of using the company's test; and the company's beliefs regarding the benefits of a test for colon cancer. 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 potential delays associated with commercializing the company's new test for colon cancer; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the risks and uncertainties associated with the regulation by the FDA 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.

* T-stage determines if there is growth of the tumor through the wall of the bowel, which is associated with higher risk of recurrence.

**Lymphovascular invasion means that cancer cells are present in the blood vessels or lymphatic vessels.

*** Mismatch repair, also known as microsatellite instability, is an alteration observed in approximately 15 percent of colon cancers. Patients with tumors identified as MSI high, or MMR deficient, are considered to be at low risk of recurrence.


SOURCE Genomic Health, Inc.