NEW YORK (GenomeWeb) – The New York State Department of Health has approved a whole-genome and transcriptome sequencing oncology test developed by the New York Genome Center for clinical testing.
According to NYGC, it is the first whole-genome cancer test to receive NY State approval.
The test includes both tumor and matched normal whole-genome sequencing as well as tumor transcriptome sequencing and is validated for fresh, frozen, and formalin-fixed paraffin-embedded samples. The test is available for both solid tumors and hematological malignancies. The NYGC researchers published an analytical validation of the assay in the Journal of Molecular Diagnostics in August on 125 tumor/normal samples.
Aside from reporting on cancer driver mutations and alterations related to therapy, the NYGC team will also report back germline findings from the 59 genes recommended by the American College of Medical Genetics and Genomics and other cancer predisposition genes, if the patient consents.
"Developing novel approaches to cancer genomics such as WGTS is part of the NYGC’s scientific focus, combining state-of-the-art genomic tools and analysis with whole-genome sequencing to help identify more effective treatments and therapies based on the tumor's genetic profile," Tom Maniatis, NYGC's CEO and scientific director, said in a statement.
Jill Taylor, director of the Wadsworth Center at the NY State Department of Health, added, "NYGC's work with this next-generation sequencing test could lead to more comprehensive disease diagnosis and personalized treatment decisions, benefitting clinicians and patients in New York and all across the country."