REDWOOD CITY, Calif., Jan. 27 /PRNewswire-FirstCall/ -- Genomic Health, Inc. announced today that it has received a letter from the Food and Drug Administration (FDA) regarding Oncotype DX(TM), the company’s genomic-based test for early stage breast cancer patients. The letter invited the company to meet with the FDA to discuss the nature and appropriate regulatory status of the company’s technology and the least burdensome ways that the company may fulfill any FDA premarket review requirements that may apply. The company plans to meet with the FDA in the near future.
Oncotype DX was launched in 2004 and to date over 2,000 physicians have utilized the test in the treatment planning for more than 7,000 breast cancer patients. Clinical laboratory services like Oncotype DX are currently regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as administered through the Centers for Medicare & Medicaid Services, as well as by applicable state laws. The test is performed at Genomic Health’s Redwood City central reference laboratory, which is accredited under CLIA and the College of American Pathology (CAP). The company’s licensed clinical laboratory and the Oncotype DX test cleared all required CLIA evaluations before the first patient test was run and results reported.
As previously disclosed in the company’s SEC filings, in December 2004, the FDA contacted the company regarding the regulatory status of Oncotype DX and the company subsequently engaged in informal communications with the FDA. In early 2005, the FDA indicated that it was considering whether Oncotype DX may be subject to FDA premarket review.
About Oncotype DX
Oncotype DX represents the first diagnostic multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit. The test has been extensively evaluated in multiple independent studies involving more than 2,600 breast cancer patients, including a large validation study published in The New England Journal of Medicine. For more information about Oncotype DX, please visit www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. is a life science company focused on the development and commercialization of genomic-based clinical diagnostic tests for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched its first test, Oncotype DX(TM), which has been shown to predict the likelihood of breast cancer recurrence and chemotherapy benefit in early stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s actions in response to the FDA. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the results of discussions with the FDA, the status of regulation by the FDA of our products and the other risks and uncertainties set forth in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2005. These forward-looking statements speak only as of the date hereof. We disclaim 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.
Genomic Health, Inc.
CONTACT: Emily Faucette of WeissComm Partners, +1-415-595-9407, forGenomic Health, Inc.; or Brad Cole of Genomic Health, Inc., +1-650-569-2281
Web site: http://www.genomichealth.com/
