Multiple Studies Presented at ASCO® Annual Meeting Demonstrate Unique, Practice-Changing Impact of Oncotype DX® to Optimize Cancer Care

REDWOOD CITY, Calif., June 1, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results of six studies being presented at the 2014 American Society of Clinical Oncology^® (ASCO^®) Annual Meeting taking place May 30 - June 3 in Chicago, underscoring the practice-changing value of Oncotype DX^® in pre-invasive and invasive breast cancer and colon cancer.

The presentations include the first Oncotype DX DCIS Score^™ clinical decision impact study, which showed a 31 percent change in treatment recommendations. Additionally, a direct comparison study of the Oncotype DX breast cancer test and the ROR score confirmed that the assays are not the same and that the information they provide is not equivalent.

Oncotype DX DCIS Score Changes Treatment Recommendations for One Out of Three Patients with Pre-Invasive Breast Cancer (Abstract #11050)

Ductal carcinoma in situ (DCIS), also referred to as stage 0 breast cancer, affects one out of every five women diagnosed with breast cancer in the United States and is often treated with surgery followed by radiation therapy and/or hormonal therapy. With only 20 percent of cases estimated to recur or turn into invasive breast cancer, it is estimated that about 40,000 women each year receive additional treatments that may not be needed.

"Currently, most DCIS patients are treated with surgery followed by radiation, despite the fact that no treatment beyond surgery has been shown to impact long-term survival," said Michael Alvarado, M.D., associate professor of surgery, the University of California, San Francisco (UCSF). "These results highlight the huge need in optimizing treatment of this non-invasive, indolent form of breast disease, and the importance of the Oncotype DX DCIS Score to help physicians reduce over- and under-treatment of DCIS."

Conducted in collaboration with Partnership for Health Analytic Research (PHAR), this multi-center study examined treatment recommendations for 115 patients from 10 sites, analyzing the change in treatment recommendations based on the Oncotype DX DCIS Score results. The study demonstrated that treatment decisions changed in 36 (31%) patients. Of the 84 patients initially recommended radiotherapy prior to Oncotype DX testing, 26 patients (31%) were recommended no radiotherapy after getting the DCIS Score result. Importantly, of the 31 patients initially recommended not to receive radiotherapy prior to Oncotype DX testing, 10 patients (32%) were reclassified towards radiotherapy after getting the DCIS Score result.

Head-to-Head Comparison Reconfirms Oncotype DX Results Are Different from Other, Prognostic-Only Tests

A comparison study in collaboration with UCSF, Marin Medical Laboratories in California, and investigators from the Athens University Medical School in Greece evaluated if the information provided by Oncotype DX and the ROR scores are equivalent.  Specifically, results in 52 node-negative, post-menopausal patients revealed a very low concordance between Oncotype DX and ROR results, (correlation = 0.08, 95% CI -0.19, 0.35) highlighting the potential to misclassify patients if other assays are used to make a decision regarding chemotherapy treatment. The high level of discordance between the Oncotype DX Recurrence Score^® and ROR results seen in this study provides additional evidence to support the findings from an independent, previously conducted 1,017-patient comparison study published in the Journal of Clinical Oncology, which showed that Oncotype DX Recurrence Score and ROR classified patients differently (correlation = 0.39) (Dowsett et al, JCO 2013).

"If the question is whether or not to use chemotherapy, Oncotype DX is the only test that has been appropriately studied and validated to answer the specific question of which invasive breast cancer patients need chemotherapy, and all multi-gene tests are not the same," said Lee S. Schwartzberg, M.D., chief, Division of Hematology Oncology, The University of Tennessee Health Science Center.

This analysis represents the fifth study highlighting the differences between the Oncotype DX breast cancer test and other tests. Previously reported results include presentations at the 2013 ASCO Annual Meeting (Schneider et al), 2012 San Antonio Breast Cancer Symposium (Poulet et al), 13th St. Gallen International Breast Cancer Conference (Poulet et al) and 2011 ASCO Breast Symposium (Dendaluri et al). 

Additional Studies Presented at ASCO on Oncotype DX in Breast and Colon Cancer Include:

• An assessment of the prognostic impact of the Oncotype DX test in node-positive, hormone receptor-positive breast cancer patients treated with adjuvant chemotherapy and endocrine therapy (Abstract #11052)
• An analysis of biomarker data from the prospective multicenter Phase II/III WSG-ADAPT trial (Abstract #524)
• An evaluation across healthcare systems showing growing adoption of Oncotype DX (Abstract #6580)
• A summary of clinical evidence detailing the clinical validation and utility of the Oncotype DX 12-gene colon cancer test (Abstract #3547)

"The breadth of work being presented at ASCO this year, including studies in breast, colon, prostate and kidney cancer, demonstrates Genomic Health's increasing commitment to improve cancer care for patients afflicted with these terrible diseases," said Phil Febbo, M.D., chief medical officer of Genomic Health, Inc. "In the era of precision medicine, it remains critical to demonstrate to physicians that assays provide practice-changing results to inform treatment choice and improve patient care."

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from screening and surveillance, through diagnosis, treatment selection and monitoring. Genomic Health'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, 2014, more than 19,000 physicians in over 70 countries had ordered more than 440,000 Oncotype DX tests. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, 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 company's intent to continue its investment to capture significant opportunities in the international and DCIS, prostate, and renal markets; the company's expectations regarding reporting study results; the attributes and focus of the company's product pipeline; the applicability of clinical study results to actual outcomes; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests in the future. 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 the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company's ability to obtain capital when needed 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 period ended March 31, 2014. 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.

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