Multiple Data Presentations Demonstrate Positive Direct Patient Impact of Oncotype DX® Breast Cancer Test Globally

REDWOOD CITY, Calif., March 20, 2015 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) today announced that 11 studies were presented at the 14^th St. Gallen International Breast Cancer Conference, including positive results from a real-life observational study in Ireland.¹ That study demonstrated that use of the Oncotype DX® test in early-stage breast cancer led to a 58 percent net reduction in chemotherapy use, resulting in net cost savings of nearly €800,000, or approximately €1,200 in cost savings per patient.

These positive findings follow several important international milestones, including the National Health Service (NHS) access program enabling public hospitals in England to provide the Oncotype DX test, the test's reimbursement for early-stage breast cancer patients by the mandatory health insurance system in Switzerland, and the recent expansion of the German Association of Gynecological Oncology's (AGO's) treatment guidelines to now include Oncotype DX for node-positive disease and late recurrence.  Furthermore, the AGO guidelines reconfirmed Oncotype DX as the only gene expression test that provides predictive information on the likelihood of chemotherapy benefit for patients with early-stage, hormone-receptor positive invasive breast cancer.

"The positive momentum we are experiencing in our European business reflects Genomic Health's leadership in spearheading the successful globalization of a value-based laboratory service in countries where significant market access requires public funding," said Brad Cole, chief operating officer and chief financial officer, Genomic Health. "We believe the increasing evidence of the value Oncotype DX is delivering to patients and healthcare systems along with our reimbursement success will fuel our business in Western Europe, allowing us to capture a significant opportunity for future revenue growth."

Large Multi-Center Study in Ireland Further Demonstrates Oncotype DX's Impact on Treatment Decisions and Chemotherapy Use (Abstract P253)

"Ireland was the first public healthcare system to reimburse this test in Europe, and the results demonstrate not only the impact of the personalized information Oncotype DX provides on treatment decisions, but also the significant cost savings associated with the use of the test over time," said Janice Walshe, M.D., study lead and consultant medical oncologist, St Vincent's University Hospital, Dublin, Ireland.

The study analyzed both the clinical and financial impact of the Oncotype DX test on adjuvant treatment decisions in early-stage breast cancer patients in the first 18 months since broad public reimbursement, using real-world data from all comprehensive cancer centers and 633 patients across Ireland. For the 583 patients with node-negative disease who were included in the analysis, there was a 59 percent change in treatment decisions after receiving the Oncotype DX Recurrence Score^® results. The use of the test led to a 58 percent net reduction in chemotherapy use and net cost savings of nearly €800,000, or approximately $886,000 U.S. dollars, from the perspective of the national public payer, the Health Service Executive.

"We are delighted that healthcare systems across Europe are recognizing the value of a personalized approach to breast cancer treatment, specifically genomic testing with Oncotype DX," said Denis Horgan, executive director, European Alliance for Personalized Medicine. "This is encouraging as decisions based on an individual patient's needs will help to ensure better patient outcomes. We certainly hope to see such tests becoming part of routine clinical practice in Europe."

Several other studies presented at the St. Gallen conference demonstrated the unique value of the Oncotype DX test in optimizing cancer care in patients with pre-invasive and early-stage invasive breast cancer, including the following:

Oncotype DX Predicts Late Recurrence in Breast Cancer (Abstract P264)

A large study analyzing 668 patients in the NSABP B-14 trial showed that the Oncotype DX test predicts late recurrence up to 15 years after initial tamoxifen therapy. Patients with low Recurrence Score results would be expected to have limited benefit from extended tamoxifen beyond five years due to much lower risk for late distant recurrence. Conversely, patients at greatest risk for late recurrences based on the Oncotype DX Recurrence Score results and quantitative estrogen-receptor (ER) score might benefit from extended tamoxifen.

"As recognized by ASCO's guideline update last June, recent studies have shown that extending tamoxifen treatment for 10 years is associated with better outcomes, however, we still need better tools to identify who those patients are," said Norman Wolmark, M.D., chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP). "This study confirms that Oncotype DX can help better define who is at greatest risk for late recurrences and the potential to benefit from extended tamoxifen, as well as those who are at lower risk and will likely have less absolute benefit from extended tamoxifen and, thus, could be spared prolonged exposure and risk of long-term side effects."

Oncotype DX Quantifies Recurrence Risk in Pre-Invasive Breast Cancer known as DCIS (Abstract P252)

Positive results of the largest genomic study in pre-invasive cancer, known as DCIS (ductal carcinoma in situ), confirmed that the Oncotype DX test is a strong, independent predictor of local recurrence, which could be either invasive breast cancer or DCIS. The primary analysis included 571 patients who were treated with breast-conserving surgery, in which the tumor was completely removed. The results of this second large clinical validation study, conducted by the Ontario DCIS Study Group of Sunnybrook Health Sciences Centre in Canada, demonstrated that the DCIS Score^TM result quantified the 10-year risk of local recurrence and provided prognostic information beyond clinical factors such as tumor size and grade. The analysis clearly identified that the majority (62 percent) of studied DCIS patients were low risk based on the tumor biology revealed by the Oncotype DX test. The results are consistent with those of the original ECOG-ACRIN Cancer Research group clinical validation study.

Comparison Study Shows Important Distinctions Between Oncotype DX and Prognostic-Only Tests (Abstract P247)

A study conducted in collaboration with the Athens University Medical School in Greece and the University of California San Francisco and Marin Medical Laboratories in California showed a very low correlation of 0.08 (95% CI -0.19, 0.35) between the information provided by the Oncotype DX test and the PAM50-based ROR score, highlighting the potential to misclassify patients if a non-predictive test is used to make a decision regarding chemotherapy treatment. These findings are consistent with a 1,017-patient comparison study published in the Journal of Clinical Oncology, which showed that the Oncotype DX Recurrence Score and ROR classified patients differently (Dowsett et al, JCO 2013). The latest comparison underscores that the tests are not interchangeable.

In addition to the results highlighted above, seven other studies were presented at this major international breast cancer symposium, representing Genomic Health's continued contribution to precision medicine and its adoption worldwide.

About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company's flagship 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. Additionally, the test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. With half a million patients tested in more than 70 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX breast cancer tests, visit: www.OncotypeDX.com or www.mybreastcancertreatment.org. 

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 diagnosis to treatment selection and monitoring. 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, Facebook, YouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that increasing evidence of the value Oncotype DX is delivering to patients and healthcare systems along with the company's reimbursement success will fuel the company's business in Western Europe, allowing the company to capture a significant opportunity for future revenue growth. 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: adequate funding for the company's test by European healthcare systems; 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 annual report on Form 10-K for the year ended December 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.

¹ Smyth L, Economic Impact of 21-gene Recurrence Score testing on Early Stage Breast Cancer in Ireland. St. Gallen 2015.

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SOURCE Genomic Health, Inc.

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