Molecular technology firm ArcherDX has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its companion diagnostic assay application with biopsy and tissue specimens.


Image: ArcherDX companion diagnostic assay for both biopsy and tissue specimens granted breakthrough device designation by FDA. Photo: courtesy of suphakit73 /

The ArcherDx companion diagnostic assay is a sequencing-based test developed to analyze more than 50 genes intended to detect somatic alterations in circulating tumor DNA (ctDNA) present in plasma and RNA or DNA derived from formalin fixed paraffin embedded (FFPE) cancer tissue.

Results generated from the ArcherDX companion diagnostic assay can be used to detect patients diagnosed with advanced non-small cell lung cancer for whom treatment with a specific targeted therapy is being considered.

The test will become the first FDA-approved multi-gene sequencing-based in-vitro diagnostic (IVD) to accept both plasma and FFPE-based inputs, if approved by the regulator.

ArcherDX chief scientific officer and executive vice president Josh Stahl said: “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.”

Archer platform combines patented Anchored Multiplexed PCR (AMP) chemistry with advanced bioinformatics software to optimize genetic mutation identification and discovery.

ArcherDX, which offers oncology-focused research products, is seeking regulatory approval for multiple companion diagnostic assays.

ArcherDX co-founder and CEO Jason Myers said: “Democratizing access to high quality, clinically relevant genomic information through FDA-approved in-vitro diagnostic products is core to our company’s mission.

“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 provides immune repertoire sequencing assays, which are said to the targeted NGS assays with human immune repertoire from RNA.

Archer product portfolio also includes Reveal ctDNA 28 assay for liquid biopsy research, VariantPlex and FusionPlex assays for SNV/indel, copy number variation (CNV) and gene fusion detection.

Immunoverse assays uses patented anchored multiplex PCR (AMP) chemistry for open-ended amplification from molecular-barcoded (MBC) adapters. Immunoverse kits are available in eight-strip formats that Immunoverse kits are available in eight-strip formats.