The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more cancer patients than the few who get it now, and lead more insurers to cover it. Foundation Medicine, based in Cambridge, Massachusetts, and others have sold tumor profiling tests for several years under more lax rules governing lab-developed tests. Evidence isn't strong enough to warrant using these gene profiling tests for earlier stages of cancer. Another leader in this field, Caris Life Sciences, says it also intends to pursue FDA approval for its widely used tumor profiling test, sold now through lab certifications. It's also working on a newer tool to profile tumor genes from a blood sample.

Source: ABC News December 01, 2017 14:00 UTC