Next-gen sequencing panel for renal Ca earns CLIA approval

November 11, 2016

The genomic profiling tool distinguishes among the dominant three malignant and one benign renal cancer subtypes.

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.

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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.

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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.

Next: Christopher Paul Filson, MD, MS, discusses announcement

 

Focus::Renal has undergone validations using more than 500 patients’ samples. Providers can perform the test on a variety of patient specimen types, including needle biopsies, fine-needle aspirates, and resected specimens, using formalin-fixed paraffin-embedded and fresh/fresh-frozen specimens, according to the release.

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Focus::Renal can distinguish among the dominant three malignant (clear cell, papillary, and chromophobe) and one benign (oncocytoma) renal cancer subtypes.

“The Focus::Renal genomic test joins an ever-increasing crowd of ‘precision medicine’-based diagnostic tests available for patient with urologic malignancies,” said Christopher Paul Filson, MD, MS, of Emory University School of Medicine, Atlanta, who has no conflicts of interest related to the Focus::Renal. “Although the press release from Cancer Genetics touts the potential promise of this test for patients with kidney cancer, the CLIA approval only demonstrates that the test is accurately and reliably measuring the cancer markers of interest. It will be critical to evaluate the broader impact on this test with clinical trials, especially in terms of whether it changes treatment decisions, and whether undergoing this test improves a patient’s overall survival.”

These tests, according to Dr. Filson, are associated with considerable costs, and determining whether personalized genomic-based medicine is cost-effective for patients with cancer will be key.

“Clearly, with so many targeted therapies available for patients with advanced kidney cancer, there is a need for genomic testing to help identify the best order of treatment. However, one must tread cautiously, as the setting of an advanced kidney cancer diagnosis can push patients and physicians to grasp onto any technologically-advanced therapies, independent of whether they have true survival benefits,” Dr. Filson said.

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