Genomic Health has announced results from its successfully completed analytical validation study of Oncotype SEQ Liquid Select, which demonstrated that this liquid biopsy mutation panel is highly sensitive, specific and reproducible.
To provide transparent and clinically meaningful performance standards, the analytical performance for Oncotype SEQ is reported on a per-sample basis rather than a per-DNA base measure.
The data were presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark.
"The high specificity, sensitivity and reproducibility of Oncotype SEQ validated in this study ensures reliable and actionable liquid biopsy test results that physicians can routinely use in clinical practice to help drive precision medicine and enable patients to make more informed treatment decisions," said Phil Febbo, M.D., chief medical officer, Genomic Health.
"Delivered through our Oncotype IQ™ Genomic Intelligence Platform, the test is designed to address the needs of about 450,000 patients who recur or present with late-stage disease each year in the United States alone, reinforcing Genomic Health's industry-leading capability to optimize cancer treatment across the patient journey."
From a simple blood draw, Oncotype SEQ uses next-generation sequencing (NGS) to detect and analyze cell-free DNA from the tumor isolated from a patient's blood to examine the four main types of genomic alterations that are associated with malignant transformation and response or resistance to therapy.
Genomic Health's proprietary liquid biopsy technology accounts for errors frequently associated with NGS to enable highly sensitive analysis of clinically relevant genomic alternations. Comprising a panel of 17 select genes, Oncotype SEQ is designed to report only clinically actionable results that can be directly used to inform the treatment of patients with stage IV solid tumors.
The test focuses on genomic markers that have been included in the National Comprehensive Cancer Network (NCCN®) guidelines or associated with sensitivity or resistance to FDA-approved therapies; the test can also match eligible patients with actively enrolling Phase II-IV clinical trials specific to their tumor type.
The validation study established the per-sample specificity of Oncotype SEQ to be greater than 99 percent. Sensitivity was also very high in that 95 percent of the time, the test was able to detect cell free DNA from the tumor present at 0.19-0.56 percent (depending on type of genetic alternation) of the total amount of cell free DNA in plasma.
These levels represent the low frequency of tumor derived cell free DNA commonly found in the plasma of patients with metastatic cancer. Study results also demonstrated that Oncotype SEQ was highly reproducible by detecting more than 95 percent of all observed variants in each run.
Genomic Health has launched a global, multi-center clinical concordance study as part of the company's goal to establish further evidence to support adoption and reimbursement of Oncotype SEQ. The study, to be conducted at 25 sites in the United States, Asia and Europe, is being led by Lee S. Schwartzberg, M.D., chief, Division of Hematology and Oncology, University of Tennessee.
Genomic Health is the world's leading provider of genomic-based diagnostic tests that help optimize cancer care by addressing the overtreatment of the disease, one of the greatest issues in healthcare today.