Genomic Health Announces Medicare Expanded Coverage Policy for Oncotype DX® Breast Cancer Test to Include Ductal Carcinoma in Situ (DCIS) Diagnosis
REDWOOD CITY, Calif., May 10, 2013 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced that, effective May 8, 2013, Palmetto GBA, the designated national contractor for its Oncotype DX® breast cancer test, has expanded its coverage policy for all qualified Medicare patients to include patients with ductal carcinoma in situ (DCIS) following the recent publication of the breast cancer test’s DCIS Score in the peer-reviewed, Journal of the National Cancer Institute.
The detection of DCIS is increasing in the United States, with more than 50,000 patients diagnosed each year. Most women with DCIS who receive breast-conserving surgery without standard radiotherapy will not develop a local recurrence, defined as either the recurrence of DCIS or the development of a new invasive cancer in the same breast. The Oncotype DX DCIS Score predicts 10-year local recurrence, DCIS or invasive carcinoma, based on a patient’s individualized underlying tumor biology regardless of whether adjuvant tamoxifen is given, providing important information beyond traditional clinical factors such as tumor size, grade, surgical margins, or menopausal status.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions. The company’s lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS). In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of March 31, 2013, more than 19,000 physicians in over 70 countries had ordered more than 350,000 Oncotype DX tests. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of renal cell cancers, as well as additional treatment decisions in breast, colon and prostate 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.mybreastcancertreatment.org and www.myprostatecancertreatment.org.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the size of the potential market opportunity for the Oncotype DX DCIS Score; the applicability of clinical study results to actual outcomes; the ability of the test to impact clinical practice; the attributes and focus of the company’s product pipeline; the potential economic benefits associated with the company’s tests; and the demand for the company’s tests. 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 company’s success retaining current contracts or levels of reimbursement coverage for its tests; the timing and results of clinical studies; the applicability of clinical study results to actual outcomes; the risks and uncertainties associated with possible additional regulation of the company’s tests both in the United States and abroad; the risks associated with competition; 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 March 31, 2013. 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, Recurrence Score, and DCIS 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.