All Cancer Patients Should Have Access To Genomic Testing - FORBES report
Days after Thanksgiving, the FDA approved Foundation Medicine’s comprehensive genetic test for evaluating cancer. The idea—and practice—of testing tumors for specific DNA or protein abnormalities is not new. Previously, the agency listed several dozen approved companion diagnostic tests; these earlier tools check one or a few molecules to inform the cancer subtype, prognosis, and likelihood of response to treatments.
The novelty of Foundation’s approach—like that of a few other companies leading the field of cancer diagnostics—is the scope of testing. These laboratories examine hundreds of genes by a method called next-generation sequencing (NGS). For a price of $5800, in two weeks’ time, Foundation reports on tumor mutation burden (TMB), microsatellite instability (MSI), and mutations in any of 324 genes that may indicate sensitivity—or resistance—to oncology drugs.
Since that approval, the Centers for Medicare and Medicaid (CMS) has been weighing if Medicare should pay for genetic testing in all patients with advanced cancers. Analysts expected a decision last week.
Most immediately, the CMS decision will affect coverage of Foundation’s assay. CMS may also determine coverage with evidence development for similar—and competing—molecular pathology tests offered by other commercial labs and hospitals that have applied to the FDA and registered in the NIH Genetic Testing Registry.
But the pending CMS decision isn’t about one biotech company or test.