Next-gen sequencing panel for renal Ca earns CLIA approval
Focus::Renal (Cancer Genetics), a genomic profiling tool covering most renal cancer markers and pathways, has earned Clinical Laboratory Improvement Amendments (CLIA) validation and approval, according to a Nov. 2 Cancer Genetics press release.
Commenting on the announcement to Urology Times, one expert said it will be important to evaluate the tool with clinical trials to determine its impact on treatment decisions as well as survival.
The next-generation sequencing panel has been developed in collaboration with and validated by cancer centers and academic institutions including Memorial Sloan Kettering Cancer Center, New York and Cleveland Clinic.
Choosing the best therapy for each patient can be challenging for those treating kidney cancer patients. The FDA has approved seven targeted therapies, including vascular endothelial growth factor (VEGF)-tyrosine kinase inhibitors, anti-VEGF monoclonal antibody and mammalian target of rapamycin inhibitors, and one immunotherapy—an anti-PD1 checkpoint inhibitor—for metastatic renal cell cancer treatment.
A growing body of evidence suggests mutations, copy number changes, and certain polymorphisms correlate with patient outcomes and renal cell carcinoma therapy response. Focus::Renal is the only panel that simultaneously detects genome-wide copy number changes, single nucleotide polymorphism genotypes, and mutations in 76 renal cancer-related genes, according to Cancer Genetics.