REDWOOD CITY, Calif., Sept. 6 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX - News) today provided initial comment on the U.S. Food and Drug Administration’s (FDA) draft guidance on “In Vitro Diagnostic Multivariate Index Assays.”
“This draft guidance represents the first public discussion surrounding the Agency’s thinking about the regulation of certain laboratory-developed tests,” said Randy Scott, Ph.D., Chairman and Chief Executive Officer of Genomic Health. “We welcome the opportunity to participate in shaping regulatory policies moving forward by providing comment on this draft guidance and encourage all stakeholders, including physicians and patients, to do the same.”
As FDA states, this draft guidance is intended for public comment and does not establish legally enforceable responsibilities at this time. Genomic Health plans to continue its ongoing dialogue with FDA regarding Oncotype DX, which went through multiple clinical trials among 2,600 patients. Since becoming commercially available in 2004, over 3,400 physicians have ordered a cumulative total of more than 15,000 test services for their 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 service 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 service cleared all required CLIA evaluations before the first patient test service was run and results reported.
As previously announced, Randy Scott will present at the Thomas Weisel Partners Healthcare Conference in Boston, MA, today, Wednesday, September 6, 2006 at 3:50 PM Eastern Time. To access the live and subsequently archived webcast of the presentation, visit the Investor Relations section of Genomic Health’s website at http://investor.genomichealth.com. Please connect to the web site at least 15 minutes prior to the beginning of each presentation to allow for any necessary software downloads. An archived replay of the company’s presentation at the Thomas Weisel Partners Healthcare Conference will be available for 30 days.
About Genomic Health
Genomic Health, Inc. 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. In 2004, Genomic Health launched its first test service, 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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 our test services by FDA, our ability to develop and commercialize new test services, unanticipated costs or delays in research and development efforts, and the other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2006. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
Source: Genomic Health, Inc.
