- Results Demonstrating 95 Percent or Greater Concordance Compared to FISH and IHC Presented at 2008 ASCO Breast - - Company to Include Reporting for HER2 Gene Expression in All Oncotype DX Reports by End of 2008 -
REDWOOD CITY, Calif., Sept. 6 /PRNewswire-FirstCall/ -- Genomic Health,
Inc. (Nasdaq: GHDX) today announced results from two studies demonstrating
that quantitative reporting for HER2 gene expression, as measured by the
company's Oncotype DX(R) breast cancer assay, has a high degree of concordance
with both fluorescence in situ hybridization (FISH) and immunohistochemistry
(IHC) testing. HER2 is an important marker for therapeutic decision-making
for patients with breast cancer, and its measurement significantly impacts the
chosen course of treatment. The research was presented at the ASCO Breast
Cancer Symposium, September 5-8, 2008, in Washington, D.C.
"Many clinicians who already rely on the Recurrence Score(R) result for
treatment planning have specifically requested that we provide the
quantitative measure of HER2 gene expression in Oncotype DX reports," said
Steven Shak, M.D., chief medical officer of Genomic Health. "Based on this
research demonstrating the accuracy and reliability of HER2 measurement using
RT-PCR, Oncotype DX can provide additional patient-specific information and
insight into each patient's individual tumor biology."
Oncotype DX uses reverse transcription-polymerase chain reaction (RT-PCR)
technology to quantify gene expression of 21 genes, one of which is HER2. The
two studies found high concordance for testing with Oncotype DX compared to
FISH (97 percent) and IHC (95 percent). Earlier this year, Genomic Health
increased the clinical utility of Oncotype DX by providing single gene
reporting for the expression of estrogen and progesterone receptors. The
company expects to further increase the clinical utility of its test by
including single gene reporting for quantitative HER2 gene expression in all
Oncotype DX reports by the end of 2008.
The first study (Abstract 13), conducted by Genomic Health and
collaborators from the Eastern Cooperative Oncology Group and sanofi-aventis,
demonstrated a high degree of overall concordance -- 95 percent -- between
central IHC and quantitative RT-PCR using Oncotype DX for determining HER2
status. The study analyzed 755 patients with 0 to 3 positive lymph nodes who
were enrolled in Intergroup study E2197, a large adjuvant breast cancer trial
evaluating two different chemotherapy regimens.
The second study (Abstract 41) found a high degree of concordance -- 97
percent -- between RT-PCR using Oncotype DX and central laboratory FISH
assessment of HER2 status. The study was conducted by Genomic Health and
collaborators from Kaiser Permanente; the University of California, San
Francisco; and PhenoPath, Inc. HER2 measurement was assessed by central FISH
and quantitative RT-PCR using Oncotype DX in 568 patients from a large Kaiser
Permanente case-control study (Habel et al., Breast Can Res 2006). As
previously reported, this study also found a significantly greater risk of
breast cancer death in patients who were determined to be HER2-positive by
Oncotype DX. Since patients in both these studies did not have the option of
Trastuzumab treatment, the direct relationship between HER2 and Trastuzumab
treatment response could not be assessed.
"During tumor sample preparation for IHC or FISH analysis, variability in
the preanalytic process may lead to differences in results and interpretation,
and, consequently, to potentially inappropriate treatment decisions," said
Frederick L. Baehner, M.D., Senior Pathologist at Genomic Health and lead
author of both studies. "Oncotype DX's RT-PCR technology for HER2 gene
expression employs a large number of controls, which are intended to safeguard
against variability in order to ensure a reproducible quantitative result."
Results from an unrelated breast cancer study to evaluate whether new
genes, including TOPO2A, might complement the Recurrence Score result and
identify individuals more likely to selectively benefit from taxanes were also
presented during the ASCO Breast Cancer Symposium.
About Oncotype DX(R)
Oncotype DX is the first and only multi-gene expression test commercially
available that has clinical evidence validating its ability to predict the
likelihood of chemotherapy benefit as well as recurrence in early-stage breast
cancer. Additionally, the test report provides quantitative scores for certain
individual genes. Oncotype DX has been extensively evaluated in multiple
independent studies involving nearly 4,000 breast cancer patients, 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. To
date, 7,500 physicians have ordered more than 65,000 tests, and health plans
covering over 80 percent of U.S. insured lives provide reimbursement for
Oncotype DX through contracts, agreements and policy decisions. Both the
American Society of Clinical Oncology (ASCO) and the National Comprehensive
Cancer Network recommend the use of Oncotype DX for patients with
node-negative breast cancer that is estrogen-receptor positive and/or
progesterone-receptor positive. For more information about Oncotype DX, please
visit http://www.oncotypedx.com.
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. In 2004, Genomic Health launched its first test,
Oncotype DX(R), which has been shown to predict the likelihood of breast
cancer recurrence and the likelihood of chemotherapy benefit in a large
portion of early-stage breast cancer patients. The company was founded in
2000 and is located in Redwood City, California. For more information, please
visit http://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 including HER2 measurement in its test
results can provide additional insight into patients' individual tumor
biology, the company's expectations regarding timing of inclusion of HER2
results in Oncotype DX reports, and the belief that the company's technology
for measuring HER2 gene expression is intended safeguard against preanalytic
variability in order to ensure a reproducible quantitative measure of HER2.
These risks and uncertainties include, but are not limited to: the results of
additional clinical studies; the applicability of clinical study results to
actual outcomes; the risk that we may not obtain sufficient levels of
reimbursement for any future tests we may develop; our ability to develop and
commercialize new products; the risks and uncertainties associated with the
regulation of our tests by FDA; our ability to obtain capital when needed; our
history of operating losses 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 three-month period ended June 30, 2008.
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.
SOURCE Genomic Health, Inc.
