Exact Sciences on Tuesday announced the U.S. launch of a next generation sequencing (NGS) therapy selection test, called OncoExTra, that is covered by Medicare.
The genomic test identifies tumor DNA and RNA alterations to generate a molecular picture of the patient's cancer, yielding results that are personalized and enabling the prescription of the most effective treatments for a specific solid tumor, Exact Sciences said.
Most eligible cancer patients do not receive comprehensive genomic profiling (CGP) to help understand their disease and guide treatment, but personalized medicine enabled by such profiling helps oncologists understand the unique biology of each patient's tumor and prescribe treatments that may lead to the best outcomes.
"The OncoExTra test substantially enhances our ability to characterize and understand solid tumors, giving our patients the best chance at treating their cancer successfully," Dr. Stephen Gruber, vice president of the City of Hope National Medical Center, said in a statement.
The test uses NGS to assess the tumor's RNA and DNA and uncover variants possibly missed by evaluating DNA alone. It profiles the exome and the transcriptome for approximately 20,000 genes and leverages a technique called matched tumor-normal sequencing, which limits false positives and allows physicians to make clinical decisions based on somatic variants detected, according to Exact Sciences.
The firm noted that the American Society of Clinical Oncology (ASCO) has updated its guidelines to recommend RNA-based fusion testing for patients with no actionable information provided by a standard DNA multigene panel test. Additionally, OncoExTra analyzes all National Comprehensive Cancer Network (NCCN)-recommended genes for patients with solid tumors and provides curated, intuitive reports.
Reports include information on targetable mutations and fusions, immuno-oncology signatures, and clinical trial options.
The company noted that Medicare covers the test, and doctors can order it to test samples for all advanced solid tumors.
Healthcare providers can also order immunohistochemical (IHC) panels and individual stains concurrently, allowing them to receive all actionable tumor information from Exact Sciences.