Therapy Areas: Oncology
ArcherDX wins US FDA breakthrough device designation for both liquid biopsy and tissue companion diagnostic assay test
9 January 2019 -

Molecular technology company ArcherDX Inc disclosed on Tuesday the receipt of US Food and Drug Administration (FDA) breakthrough device designation to help accelerate the patient access for its companion diagnostic assay test for both liquid biopsy and tissue specimens.

The company added that 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.

According to the company, the 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.

Following approval, this test could be the first US FDA-approved multi-gene sequencing-based in-vitro diagnostic (IVD) to accept both plasma and FFPE-based inputs, concluded the company.

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.