Genomic Health Announces New Data Reinforcing Clinical Utility of Oncotype DX® in Multiple Breast Cancer Populations

Studies Presented at the CTRC-AACR San Antonio Breast Cancer Symposium Provide Insights Into Treatment Impact for Node-Positive Patients; Demonstrate Potential Role of Oncotype DX in Neoadjuvant Treatment Planning

REDWOOD CITY, CA, Dec 15, 2009 (MARKETWIRE via COMTEX News Network) -- Genomic Health, Inc. (NASDAQ: GHDX) today announced results from five new studies on its Oncotype DX® breast cancer test, a multi-gene expression test that physicians currently use to predict the likelihood of chemotherapy benefit and recurrence risk for patients with early-stage breast cancer. These data were presented at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held December 9 - 13, 2009, in San Antonio, TX.

"The breadth of data presented at last week's meeting reflects our enduring commitment to provide physicians and their breast cancer patients with accurate and precise clinical information that can be used to make individualized treatment decisions," said Steven Shak, M.D., chief medical officer of Genomic Health. "We believe no other breast cancer test laboratory has demonstrated the reproducible clinical utility that Genomic Health has established with Oncotype DX, and we plan to continue to add value to the test through our ongoing research and clinical experience that includes more than 120,000 breast cancer patients."

Highlights from the five studies presented by Genomic Health and research collaborators include:

Oncotype DX Predicts Anthracycline-Based Chemotherapy Benefit in Women with ER+, N+ Breast Cancer 

--  An analysis, presented as a late-breaking poster during a discussion on
multigene assays on Thursday, December 10, reinforced the conclusion that
chemotherapy does not appear to benefit patients with either 1-3 or 4 or
more positive nodes for disease-free survival over 10 years, if their
tumors have a low Recurrence Score(R) result.  Researchers from Southwest
Oncology Group (SWOG), a National Cancer Institute-supported clinical
trials cooperative group, observed no breast cancer specific survival
(BCSS) benefit from chemotherapy in either the low (log-rank p=0.56) or
intermediate (log-rank p=0.89) Recurrence Score categories; however,
chemotherapy resulted in superior BCSS in the high Recurrence Score
category (log-rank p=0.033).

Oncotype DX Leads to Fewer Recommendations of Chemotherapy for Women with Node-Positive Breast Cancer 

--  A multi-institutional clinical survey presented on Friday, December 11
involving 160 physicians who currently use Oncotype DX in node-positive
breast cancer patients found that treatment recommendations frequently
changed based on Recurrence Score results, with an overall reduction in
chemotherapy treatment recommendations.  In the 138 patients with
node-positive, hormone receptor-positive breast cancer where the physician
had a specific treatment recommendation before obtaining the Oncotype DX
Recurrence Score, recommended treatment changed from hormonal therapy plus
chemotherapy to hormonal therapy alone in 46 patients (33%), and from
hormonal therapy alone to hormonal therapy plus chemotherapy in 13 patients
(9%) after obtaining the Recurrence Score.

Oncotype DX Can Be Successfully Performed on Breast Cancer Core Biopsy Samples, Suggesting Potential Role in Neoadjuvant Treatment Planning 

--  On Sunday, December 13, researchers presented results from a study
examining pathology review and quantitative RT-PCR analysis by Oncotype DX
on more than 11,000 core biopsy samples processed at the Genomic Health
laboratory between July 15, 2005 and May 31, 2009.  Physicians use core
needle biopsies to obtain breast cancer tumor tissue without surgery for
the purposes of diagnosis.  Surgery, adjuvant, and neoadjuvant treatment
decisions are based on the analysis of core needle biopsy tissue.  The
overall Oncotype DX success rate in core biopsy samples was greater than 97
percent, demonstrating that RT-PCR analysis by Oncotype DX can successfully
be performed on core biopsies that have been fixed and paraffin-embedded.

Previous studies have shown the Recurrence Score result to be associated
with the likelihood of response to neoadjuvant therapy(i)(ii)(iii).
Patients with a higher Recurrence Score result had a greater chance of
experiencing a response from neoadjuvant chemotherapy while patients with a
lower Recurrence Score appeared to be more likely to achieve a response
from endocrine therapy.  Genomic Health plans to further assess the role of
Oncotype DX in the neoadjuvant setting through a number of ongoing clinical
trials.

Exploratory Analysis of Gene Expression Identifies New Potential Therapeutic Targets, Biomarkers Associated with Recurrence 

--  In a study presented Saturday, December 12, researchers analyzed 371
genes and compared expression levels between hormone receptor-positive
breast cancer cases and hormone receptor-negative cases.  A number of the
genes tested exhibited significantly higher expression in hormone
receptor-positive breast cancer and pathway analysis showed substantial
interconnectivity among these genes.  The analysis further revealed several
pathways that exhibit higher expression in hormone receptor-positive
disease -- some of which were also associated with a higher risk of
recurrence after chemohormonal therapy -- suggesting that they may be
potential therapeutic targets and providing a rationale for evaluating both
currently available and investigational agents that target these
pathways.

Oncotype DX and FISH Testing Both Detect Amplified HER2 Expression with Extra Copies of Chromosome 17 

--  On Sunday, December 13, Genomic Health researchers presented results of
a large retrospective case-control study assessing the diagnosis of HER2
status, by both fluorescent in situ hybridization (FISH) testing and
quantitative RT-PCR by Oncotype DX, to explore the association between
polysomy 17 (extra copies of chromosome 17, a condition found in breast
cancer patients that can complicate the interpretation of HER2 testing
results), HER2 status and breast cancer death.  Polysomy 17 was found in
HER2-amplified tumors in approximately a third of cases.  While differences
were not statistically significant, HER2-positive patients with polysomy 17
tended to have a worse prognosis than other breast cancer patients.
Quantitative RT-PCR by Oncotype DX for HER2 status is highly concordant
with HER2 status assessed by FISH and therefore is an alternative to
FISH.

About Oncotype DX® The Oncotype DX breast cancer test is the only multigene 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. The Oncotype DX breast cancer test 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. As of November 2009, more than 8,000 physicians have ordered more than 120,000 tests in over 50 countries, and both Medicare and private health plans covering over 90 percent of U.S. insured lives, provide reimbursement for Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive through contracts, agreements or policy decisions. Both the American Society of Clinical Oncology 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 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 the Oncotype DX® breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health is preparing to launch its Oncotype DX colon cancer test in the first quarter of 2010. 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, including statements relating to the company's belief that the breadth of data presented reflects the company's commitment to provide physicians and their breast cancer patients with accurate and precise clinical information that can be used to make individualized treatment decisions, the company's belief that no other breast cancer test has demonstrated the reproducible clinical utility that Genomic Health has established with Oncotype DX, the company's plan to continue to add value to its breast cancer test through ongoing research and clinical experience, the belief that using Oncotype DX can predict chemotherapy benefit in women with ER+, N+ disease, the belief that Oncotype DX frequently changes treatment recommendations with an overall reduction in chemotherapy, the belief that Oncotype DX may have a potential role in neoadjuvant treatment planning and the company's plans regarding additional studies in this regard, the belief that certain study results provide a rationale for evaluating currently available and investigational agents that target certain pathways, the company's plans to commercialize a test for colon cancer and the proposed timing of such commercialization, and the applicability of clinical study results to actual outcomes. 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 potential delays associated with commercialization of a new test; the risks and uncertainties associated with the regulation of the company's tests; the applicability of clinical study results to actual outcomes; 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 September 30, 2009. 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.

(i) Chang JC, Makris A, Gutierrez MC, et al. Gene expression patterns in formalin-fixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in breast cancer patients. Breast Cancer Res Treat. 2008;108(2):233-240.

(ii) Gianni L, Zambetti M, Clark K, et al. Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer. J Clin Oncol. 2005;23(29):7265-7277. Epub 2005 Sep 6.

(iii) Akashi-Tanaka S, Shimizu C, Masashi A, et al. 21-gene expression profile assay on core needle biopsies predicts responses to neoadjuvant endocrine therapy in breast cancer patients. The Breast 2009;18(3):171-174.

Video-Link Available: http://www2.marketwire.com/mw/frame_mw?attachid=1137083 

Contacts:

Investors:
Brad Cole
Genomic Health
650-569-2281
investors@genomichealth.com

Media:
Emily Faucette
Genomic Health
415-595-9407
media@genomichealth.com

SOURCE: Genomic Health 

mailto:investors@genomichealth.com
mailto:media@genomichealth.com

 

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This website contains forward-looking statements. Any statements contained in this website that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including risks and uncertainties associated with the reimbursement for and adoption of Oncotype DX; commercialization of any future tests; the nature and sources of our revenues; our dependence on collaborative relationships; the regulation of Oncotype DX or any future tests we may develop by the FDA; the attributes of our products; the benefits of personalized medicine and its ability to impact treatment decisions; the outcome and success of clinical trials; the applicability of clinical results to actual outcomes; the company's beliefs regarding the potential benefits that may be obtained from additional tests; and other factors detailed from time to time in Genomic Health's periodic filings with the Securities and Exchange Commission. Genomic Health, Inc. specifically disclaims any obligation to update any forward-looking statements.