ArcherDX Receives Breakthrough Device Designation to Detect NTRK Gene Fusions

ArcherDX, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its next-generation sequencing (NGS) device under development as a companion diagnostic (CDx) to detect neurotrophic receptor tyrosine kinase (NTRK) gene fusions that lead to the formation and growth of cancer. ArcherDX’s NGS technology utilizes proprietary Anchored Multiplex PCR (AMP™) chemistry that captures DNA, RNA or ctDNA from both blood and tissue samples regardless of the location of the tumor.

Find out more in the press release.

Categories: Ecosystem News