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One step closer to approval
February 2019
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BOULDER, Colo.—ArcherDX Inc. has received a Breakthrough Device designation for its companion diagnostic assay, which is “a sequencing-based test analyzing 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 (FFPE) cancer tissue.” This assay can be used to identify non-small cell lung cancer patients who could qualify for a specific targeted therapy, and if approved, could be the first FDA-approved multi-gene sequencing-based in-vitro diagnostic that accepts both plasma and FFPE 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 CEO 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.”

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