The Oncotype DX® Test and Precision Oncology: New Data Presented at ESMO Further Demonstrate Genomic Health’s Successful Approach to Understanding Tumour Biology

• Presentation of positive results from additional prostate cancer clinical validation study
• Further evidence of the practice-changing impact of the Oncotype DX test in breast cancer 

GENEVA, Switzerland, [September 29, 2014] — In line with this year’s theme for the annual European Society for Medical Oncology (ESMO) Congress – ‘Precision Medicine in Cancer Care’ – Genomic Health presented results from multiple studies across different cancer types demonstrating how its genomic test Oncotype DX has led to a greater understanding of cancer at the molecular level, enabling more personalised treatment decisions.

Data from the additional prostate cancer clinical validation study¹ confirm that the Genomic Prostate Score (GPS) provided by the Oncotype DX prostate cancer test is a significant predictor of disease aggressiveness at the time of diagnosis based on assessment of biopsies from the tumour and provides information beyond currently available risk factors. In particular, this new study confirms Oncotype DX as a predictor of adverse pathology from the biopsy, as previously demonstrated in a published validation study², and demonstrates the test’s ability to predict the risk of recurrence after surgery.

‘Each year, more than 400,000 men in Europe are diagnosed with prostate cancer. However, existing methods of examining small amounts of needle biopsy tissue are not adequate for predicting which cancers will be aggressive. This limitation leads many physicians and patients to pursue immediate prostate cancer treatment, even when patients display low risk features with minimal risk of the advancement of prostate cancer and its known sequelae,’ said Dr. Jennifer Cullen, Lead Investigator of the study under a Cooperative Research and Development Agreement with the Uniformed Services University of the Health Sciences’ Center for Prostate Disease Research (CPDR), Rockville, Maryland, USA. ‘The results of this study confirm that the information provided by the Oncotype DX prostate cancer test can help physicians and patients choose the most appropriate treatment approach, based on an individualised risk assessment.’

The CPDR is a multi-disciplinary prostate cancer research program of the Department of Surgery at the Uniformed Services University of the Health Sciences, the U.S. Department of Defense’s federal health sciences university. The center is a collaboration with The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., a private, not-for-profit organisation authorised by Congress to support medical research and education at the University.

The Oncotype DX prostate cancer test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness. The test results are reported as a Genomic Prostate Score (GPS) that ranges from 0 to 100 and is combined with other clinical factors to further clarify a man’s risk prior to treatment intervention. This first-of-its-kind, multi-gene test has been validated to guide treatment decisions using the prostate needle biopsy sample taken before the prostate is removed − thereby providing the opportunity for low-risk patients to avoid invasive treatments such as radical prostatectomy or radiation.

The Oncotype DX prostate cancer test is commercially available worldwide.

Wealth of data reinforcing practice-changing impact of the Oncotype DX test in breast cancer

Additional data presented at ESMO include:

• Results from the PACS01 trial³ demonstrating that the Oncotype DX breast cancer test predicts risk of recurrence and survival in pre- and post-menopausal patients treated with adjuvant taxane containing chemotherapy. Results reinforced the existing body of evidence⁴ and showed that the Recurrence Score was a significant predictor of distant recurrence and disease free survival with a similar performance in both patient groups (p-value <0.001).
• A head-to-head comparison⁵ study with 70 patients showing that the Oncotype DX results and the Risk of Recurrence (ROR) score provide different information. The high level of discordance between the Oncotype DX Recurrence Score and ROR risk classification seen in this study demonstrates that these tests are not interchangeable and reinforces Oncotype DX test’s unique value as predictive of chemotherapy benefit.
• Results of a large, positive study⁶ confirming that the Oncotype DX Recurrence Score results and quantitative ER expression predict late (five to 15 years) distant recurrence risk in certain early- stage invasive breast cancer patients after initial tamoxifen therapy. These results suggest that the Oncotype DX test may help identify which patients have greater potential to benefit from extended hormonal treatment beyond five years.

‘At Genomic Health, our mission is to improve the quality of cancer treatment decisions by developing high-value diagnostics that enable more personalised decisions based on the genomic activity within a patient’s individual tumour. The data presented at ESMO address important clinical questions and continue to highlight the distinguishing features and value of the Oncotype DX platform in guiding the treatment of early stage cancer,’ said Christer Svedman, M.D., Director of Medical Affairs Europe at Genomic Health.

About Genomic Health
Genomic Health, Inc. is a world’s leading provider of genomic-based diagnostic tests that inform treatment decisions and help to ensure each patient receives appropriate treatment for early stage cancer. The company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey, from screening and surveillance, through diagnosis and treatment selection.
The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX, visit: www.OncotypeDX.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 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 quarter ended June 30, 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 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.

1. Cullen J. et al., Abstract #LBA22 presented at ESMO 2014

2. Klein EA et al., Eur Urol. 2014; 66:1: 550-60

3. Penault-Llorca F. et al., Abstract #174P presented at ESMO 2014

4. Mamounas EP, Tang G, Paik S, et al: 2012 ASCO Breast Cancer Symposium

5. Alvarado M. et al., Abstract #287P presented at ESMO 2014

6. Mamounas T. et al., Abstract #177P presented at ESMO 2014

Contact:
Media:
Federico Maiardi
Genomic Health
+41 79 138 1326
[email protected]