ArcherDx Inc, Boulder, Colo, a molecular technology company dedicated to developing solutions that advance the application of personalized genomic medicine, has been granted an FDA breakthrough device designation for its companion diagnostic assay application. The agency’s breakthrough device designation is intended to accelerate patient access to medical devices that provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions by expediting their development, assessment, and review.

Josh Stahl, ArcherDx.

Josh Stahl, ArcherDx.

“The acceptance of this assay for breakthrough device designation is a key milestone for our collaboration with FDA and is an important step to advancing precision medicine options for patients and our biopharma partners,” says Josh Stahl, chief scientific officer and executive vice president of ArcherDx. “This designation allows us to work closely with FDA as we prepare our submission for this unique offering that empowers pathologists in the United States and around the world to run this test in their local lab, helping to reduce costs and improve test turnaround time for these critically ill patients.”


Jason Myers, ArcherDx.

The ArcherDx companion diagnostic assay is a sequencing-based test analyzing more than 50 genes, and is intended for detection of somatic alterations in circulating tumor DNA present in plasma and in RNA or DNA derived from formalin-fixed, paraffin-embedded (FFPE) cancer tissue. Results of the ArcherDx companion diagnostic assay 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. If approved, this test could be the first FDA-approved multigene sequencing-based in vitro diagnostic to accept both plasma and FFPE-based inputs.

“Democratizing access to high-quality, clinically relevant genomic information through FDA-approved in vitro diagnostic products is core to our company’s mission,” says Jason Myers, cofounder and chief executive officer of ArcherDx. “We look forward to working with our collaborators to build upon this breakthrough designation and ultimately expand the companion diagnostic claims associated with the assay beyond lung cancer.”

To learn more, visit ArcherDx.