New NCCN Breast Cancer Guidelines Elevate Oncotype DX Breast Recurrence Score® as the Only Preferred Multi-gene Test to Predict Chemotherapy Treatment
Updated NCCN Guidelines Underscore the Unique Advantage of the Oncotype DX® Test in Predicting Chemotherapy Benefit
REDWOOD CITY, Calif., Oct. 9, 2018 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) today announced that its Oncotype DX Breast Recurrence Score® test has been categorized as the only "preferred" test for chemotherapy treatment decision-making for patients with node-negative early-stage breast cancer by the National Comprehensive Cancer Network (NCCN) in its 2018 guidelines for invasive breast cancer chemotherapy treatment. The only test elevated to "strongly consider" guideline inclusion with level 1 evidence, Oncotype DX continues to be distinguished as the only genomic test predictive of chemotherapy benefit.
NCCN's guidelines update follows the recent publication of results of Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by ECOG-ACRIN Research Group. The largest adjuvant treatment breast cancer trial to date, TAILORx involved 10,273 women across 1,100 trial sites in six participating countries. The study results, published in The New England Journal of Medicine, demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving.
Additionally, the NCCN guidelines elevated Oncotype DX into the algorithm for chemotherapy treatment of patients with micrometastases and one to three positive lymph nodes.
"We are pleased NCCN continues to clearly distinguish Oncotype DX from other genomic tests based on clinical evidence and the critical importance of predicting chemotherapy benefit," said Steven Shak, M.D., chief scientific and medical officer, Genomic Health. "This new strengthened NCCN guidelines, combined with the recent inclusion of Oncotype DX in international guidelines, demonstrates global support for Oncotype DX as the only 'preferred' test to guide optimal treatment based on its unique ability to predict chemotherapy benefit."
NCCN is an alliance of 21 world-leading cancer centers dedicated to improving the quality and effectiveness of care provided to patients with cancer. The 2018 guidelines were published online this week.
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 900,000 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.MyProstateCancerTreatement.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 900,000 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 significance of molecular diagnostics in breast cancer treatment planning, the value of the individualized tumor information provided by Oncotype DX, the belief that the use of Oncotype DX has been accepted as standard practice for individualized breast cancer treatment decisions, and the ability of guidelines reports, including the recent publication of the 2018 NCCN guidelines, to influence or expand global reimbursement coverage and use of the Oncotype DX test. These risks and uncertainties include, but are not limited to: the applicability of clinical results to actual outcomes; the ability of our test to continue to impact treatment decisions; our ability to increase usage of our tests; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing tests and any future tests we may develop; the risk of delay in developing new products or product enhancements; the risks and uncertainties associated with the regulation of our test by FDA; our ability to obtain capital when needed; our history of operating losses; the results of clinical studies and the other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the quarter June 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, Recurrence Score, Oncotype DX AR-V7 Nucleus Detect, Oncotype DX Breast DCIS Score, Oncotype DX Genomic Prostate Score 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.