February 2019—ArcherDx announced that the FDA granted a breakthrough device designation for its companion diagnostic assay application. The ArcherDx companion diagnostic assay is a sequencing-based test that analyzes more than 50 genes intended for detection of somatic alterations in circulating tumor DNA present in plasma and in RNA or DNA derived from formalin-fixed, paraffin-embedded cancer tissue. Results will be used to identify patients diagnosed with advanced non-small cell lung cancer for whom treatment with a specific targeted therapy is being considered.
ArcherDx, 303-357-9001