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The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.
Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.
The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments.