NICE Expands Recommendation for the Oncotype DX Breast Recurrence Score® Test to More Patients with Early-Stage Breast Cancer Within the United Kingdom
- Only test recommended based on its ability to predict chemotherapy benefit
- Recommendation expanded to include patients with micrometastatic disease
REDWOOD CITY, Calif. – December 19, 2018 – Genomic Health, Inc. (NASDAQ: GHDX) today announced that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its updated guidance again recommending the Oncotype DX Breast Recurrence Score® test for use in clinical practice to guide adjuvant chemotherapy treatment decisions for certain patients with early-stage breast cancer. Further, NICE expanded its recommendation to include patients with micrometastases, indicating that some cancer cells have spread to the lymph nodes.
“Oncotype DX is the only test that provides specific information about an individual patient’s response to chemotherapy, correctly identifying the important minority of patients who will receive substantial treatment benefit and the majority of patients who will not benefit from chemotherapy,” said Simon D H Holt, Honorary Consultant Surgical Oncologist, Peony Breast Care Unit at Prince Philip Hospital in Llanelli, UK. “This test allows us to target treatment much more effectively and should be routinely used for all eligible patients.”
The recommendation of the Oncotype DX Breast Recurrence Score test in NICE’s updated guidance is based on the test’s unique ability to predict who will benefit from chemotherapy and who will not. Importantly, NICE acknowledges Oncotype DX as the only test that reduces the overall number of patients who receive chemotherapy, as well as the only test supported by long-term patient outcomes evidence, including the recently published landmark TAILORx study. Further, NICE also found the Oncotype DX test to be the most cost-effective tool in guiding chemotherapy treatment.
“We believe this positive endorsement from NICE reflects the growing global recognition of the unique value Oncotype DX provides,” said Torsten Hoof, senior vice president, international, Genomic Health. “As we continue to experience an increasing impact of the TAILORx study results on clinical practice, we believe we are one step closer to broadening Oncotype DX access through increased reimbursement in Western Europe and around the world.”
The predictive value of the Oncotype DX Breast Recurrence Score test was also recently acknowledged by Germany’s health technology assessment body, the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that only the Oncotype DX test has sufficient evidence to guide breast cancer adjuvant chemotherapy decisions based on the TAILORx study results.
Additionally, the U.S. National Comprehensive Cancer Network (NCCN) categorized Oncotype DX as the only “preferred” test for chemotherapy treatment decision-making for node-negative, early-stage breast cancer patients in its 2018 updated treatment guidelines.
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 Recurrence Score® test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score® test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score® test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention. With more than 950,000 patients tested in more than 90 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 tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that help optimize cancer care, including addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company’s flagship line of Oncotype DX® gene expression tests that have been used to guide treatment decisions for more than 950,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype DX® AR-V7 Nucleus Detect™ test. The company is based in Redwood City, California, with international 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 the Oncotype DX Breast Cancer test is unique in its ability to predict chemotherapy benefit in early-stage breast cancer; the company’s belief that the Oncotype DX Breast Cancer test is cost effective and can reduce the cost of treatment in the United Kingdom and in various other health systems around the world; that the recommendation by NICE will lead to increased use of the Oncotype DX Breast Cancer test in the United Kingdom; the applicability of study results to actual outcomes; and the ability of the company’s tests to impact clinical practice. 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 company’s ability to increase usage of its tests; the company’s ability to successfully commercialize its tests outside of the United States; the company’s ability to compete against third parties; 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 and uncertainties associated with regulation of the company’s tests; the results of clinical studies; 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, 2018. 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, Breast Recurrence Score, DCIS Score, Genomic Prostate Score, Oncotype DX AR-V7 Nucleus Detect, and Oncotype IQ 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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