Genomic Health Announces Plans to Launch Liquid Biopsy Mutation Panel in 2016
Original article featured on Genomic Health.
REDWOOD CITY, Calif., Jan. 11, 2016 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced plans to launch its first liquid biopsy test, Oncotype SEQ™, in mid-2016. The test is a blood-based mutation panel that uses next-generation sequencing to identify select actionable genomic alterations for the treatment of patients with late-stage lung, breast, colon, melanoma, ovarian or gastrointestinal cancer. As a fit-for-purpose panel, Oncotype SEQ is designed to meet the needs of community oncologists by delivering actionable clinical information to the more than 350,000 cancer patients who recur or present with late-stage disease each year in the United States alone.
“Non-invasive liquid biopsy tests offer a significant opportunity to transform the management of cancer, and it is our goal to deliver multiple products across oncology and urology beginning with Oncotype SEQ,” said Phil Febbo, M.D., chief medical officer of Genomic Health. “We believe we are well positioned to lead this new market given our experience developing cancer tests that are optimized for clinical utility and patient access, along with our operational expertise and unmatched commercial channel.”
Oncotype SEQ represents the first of several liquid biopsy tests that Genomic Health plans to deliver through the introduction of its Oncotype IQ™ Genomic Intelligence Platform. This 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 600,000 cancer patients worldwide. In the future, Genomic Health plans to expand its test portfolio through both internal product development and partnerships to include additional tissue and liquid-based tests for the management and monitoring of multiple cancer types.
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 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 the timing of the planned launch of Oncotype SEQ and the expected attributes and benefits of the panel; the company’s belief that it is well-positioned to lead the new liquid biopsy market; and the company’s plans to deliver additional tests through its IQ Genomic Intelligence Platform. 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 completion of the company’s quarter and year-end close processes, and adjustments that may result from such processes; the impact of ERP implementation on the company’s business; the risks and uncertainties associated with the regulation of the company’s tests; the results and timing of results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the company’s ability to develop and commercialize new tests, including Oncotype SEQ, and expand into new markets domestically and internationally; the risk that the company may not obtain, within its time expectations or at all, 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; 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, 2015. 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.