Genomic Health, Inc. announced the commercial launch of Oncotype SEQT Liquid Select, the first of several non-invasive liquid biopsy tests that the company plans to deliver through its Oncotype IQT genomic intelligence platform.
Oncotype SEQ is a blood-based test that uses next-generation sequencing to identify and assess actionable genomic alterations in a panel of 17 select genes to address the treatment of stage IV solid tumors, including lung, breast, colon, melanoma, ovarian, and gastrointestinal stromal tumors.
The test is designed to provide clinically actionable information focused on genomic markers that have either been included in National Comprehensive Cancer Network guidelines or associated with sensitivity or resistance to relevant FDA-approved therapies. The test can also match eligible patients with actively enrolling Phase II-IV clinical trials specific to their tumor type.
“This blood-based test will provide oncologists with important genomic information reported in a manner that will allow efficient interpretation and identification of potential treatment options,” Phil Febbo, MD, chief medical officer, Genomic Health, said.
By analyzing cell-free DNA (cfDNA) isolated from a patient’s blood through a simple blood draw, Oncotype SEQ examines tumor-derived genomic alterations that are associated with malignant transformation and response or resistance to therapy. Using unique bioinformatics methodology, the test detects the four major types of variants with very high sample-level sensitivity and specificity.
The comprehensive Oncotype SEQ report provides physicians with important molecular alterations information in a streamlined format that facilitates interpretation and connection to potential treatment options.
“Liquid biopsy assesses cancer changes through a simple blood draw, a desirable choice for many patients, as it is a minimally invasive way to capture tumor genomic alterations and heterogeneity with the potential to be more cost- and time-efficient,”Lee Schwartzberg, MD, chief of the hematology oncology department at the University of Tennessee, said. “Armed with this clinically meaningful information, Oncotype SEQ will allow physicians to be more effective and efficient in exploring treatment and clinical trial options for late-stage cancer patients.”
The initial phase of the targeted launch will be focused on select clinics for the treatment of stage IV lung cancer patients, according to the company. Liquid biopsy is a particularly viable option for lung cancer patients due to the difficulty and risk associated with lung tissue biopsy and the number of clinically actionable alterations.
With successful analytical validation results being submitted for presentation, Genomic Health has launched a global, multi-center clinical concordance study as part of the company’s goal to establish further evidence to support reimbursement. Oncotype SEQ will be performed at Genomic Health’s CLIA-certified laboratory using the company’s proprietary cfDNA sequencing platform.
