Genomic Health Announces Medicare Coverage for Oncotype DX® Colon Cancer Test

REDWOOD CITY, Calif., Sept. 30, 2011 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that Palmetto GBA, the designated national contractor for its Oncotype DX® colon cancer test, has established a formal coverage policy for all Medicare patients.  The Oncotype DX colon cancer test has been clinically validated to predict risk of recurrence in patients with stage II colon cancer.

"Palmetto's coverage decision reflects the importance of evidence-based coverage and has the potential to transform care for Medicare colon cancer patients while saving the healthcare system dollars," said Kim Popovits, chief executive officer at Genomic Health. "This coverage decision allows all appropriate Medicare patients access to Oncotype DX for colon cancer and further recognizes the value our tests are delivering to physicians, payors and patients."

The policy covers men and women with stage II colon cancer. Palmetto's decision is based on the two large QUASAR and CALGB clinical validation studies in addition to clinical utility information. Coverage for the Oncotype DX colon cancer test was posted on the Palmetto GBA website on September 29, 2011 and can be referenced by clicking here. The coverage is effective for claims for services performed on or after September 18, 2011.

"The Oncotype DX colon cancer test allows physicians to go beyond the limited set of clinical and pathologic markers that they previously used in an effort to make a more precise risk assessment in the treatment planning for stage II colon cancer patients," said David Kerr, M.D., DSc, professor of cancer medicine at the University of Oxford and a principal investigator of the QUASAR validation study. "Medicare's decision will help ensure broader patient access to this important diagnostic test." 

The landmark QUASAR validation study, which established a new paradigm for assessing recurrence risk in stage II colon cancer, emphasizing the critical role of the Oncotype DX Recurrence Score®, mismatch repair (MMR) status and T-stage, has been accepted for publication by the Journal of Clinical Oncology. This year Genomic Health plans to expand its Oncotype DX colon cancer offering to include  immunohistochemistry (IHC) testing for MMR status to assess mismatch repair for stage II colon cancer recurrence risk.

Reimbursement for the Oncotype DX colon test was established by Palmetto using an extensive resource based analysis and an independent pharmacoeconomic analysis, and is consistent with previous decisions by other payors.

About Genomic Health and the Oncotype DX® Tests

Genomic Health, Inc. (NASDAQ: GHDX) is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions.

Its lead product, the Oncotype DX Breast Cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer to help optimize treatment options. Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.(1) The test is also recognized in international guidelines issued by St. Gallen International Breast Cancer Expert Panel and European Society for Medical Oncology (ESMO).

Physicians also use the Oncotype DX Breast Cancer test to make treatment recommendations for certain node-positive breast cancer patients. Oncotype DX 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. 

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. Genomic Health collaborated with the National Surgical Adjuvant Breast and Bowel Project and Cleveland Clinic on a total of four development studies in more than 1,800 to analyze patients with stage II colon cancer.  The final gene panel was then independently evaluated in more than 1,400 stage II colon cancer patients in the QUASAR validation study. 

As of June 30, 2011, more than 10,000 physicians in over 60 countries had ordered more than 200,000 Oncotype DX breast and colon cancer tests.  Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional stages of breast and colon cancers.  The company is based in Redwood City, California with European headquarters in Geneva, Switzerland.  For more information, please visit www.genomichealth.com.  To learn more about Oncotype DX tests, visit: www.oncotypedx.com and www.untileverywomanknows.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 coverage decision by Palmetto will enable broader access to its colon cancer test the company's belief that the coverage decision further recognizes the value the company's tests are delivering to physicians, payors and patients; the company's plans to expand its colon cancer offering to include IHC testing for MMR status to assess mismatch repair for stage II colon cancer risk; the potential of the test to transform care for Medicare colon cancer patients while saving the healthcare system money; the applicability of study results to clinical practice; the ability of the test to optimize cancer treatment and the anticipated publication of the Quasar validation study results in the Journal of Clinical Oncology. 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 implementation of the coverage decision by Palmetto; the risk that the coverage decision is subject to change; regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; risks associated with competition and commercialization of  the test;  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 period ended June 30, 2011. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

(1) ASCO and NCCN are registered trademarks of the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN), respectively.  ASCO and NCCN do not endorse any product or therapy.

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.

SOURCE Genomic Health, Inc.