BOULDER, CO-ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for ArcherDx’s companion diagnostic assay application. The FDA’s Breakthrough Device designation is intended to help accelerate patient access to medical devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions by expediting their development, assessment and review.
“The acceptance of this assay for Breakthrough Device designation is a key milestone for our collaboration with the FDA and is an important step to advancing precision medicine options for patients and our biopharma partners,” said Josh Stahl, chief scientific officer and executive vice president of ArcherDX. "This designation allows us to work closely with the FDA as we prepare our submission for this unique offering that empowers pathologists in the U.S. and around the world to run this test in their local lab, helping to reduce costs and improve test turn around time for these critically ill patients.”
The ArcherDx companion diagnostic assay is a sequencing-based test analyzing more than 50 genes intended for detection of somatic alterations in circulating tumor DNA (ctDNA) 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 multi-gene sequencing-based in-vitro diagnostic (IVD) 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," said Jason Myers, co-founder 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.”
ArcherDX is advancing molecular pathology with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplexed PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform dramatically enhances genetic mutation identification and discovery. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. Learn more at archerdx.com.
ArcherDX is headquartered in Boulder, Colorado.
2477 55th Street, Suite 202
Boulder, CO 80301