FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

ArcherDX’s Companion Diagnostic Assay Receives Breakthrough Designation

Jan. 10, 2019

The FDA granted breakthrough designation to ArcherDX’s companion diagnostic assay for both liquid biopsy and tissue specimens.

The results of the diagnostic assay will be used to pinpoint patients diagnosed with advanced non-small cell lung cancer for whom treatment using a specific targeted therapy is being considered.

The sequencing-based assay analyzes more than 50 genes in order to detect somatic alterations in somatic tumor DNA (ctDNA) found in plasma and in RNA or DNA derived from cancer tissue.

View today's stories