ArcherDX has secured the US Food and Drug Administration (FDA) breakthrough device designation for its next-generation sequencing (NGS) device, which is currently under development.
The NGS device is a companion diagnostic (CDx) to detect neurotrophic receptor tyrosine kinase (NTRK) gene fusions, which help the formation and growth of cancers.
ArcherDX said that its NGS technology will leverage advanced Anchored Multiplex PCR (AMP) chemistry that captures DNA, RNA or ctDNA from both blood and tissue samples regardless of the location of the tumor.
ArcherDX chief executive officer and co-founder Jason Myers said: “NTRK gene fusions are notoriously difficult to detect in cancer.i ArcherDX’s next-generation sequencing technology uses RNA to provide sensitive NTRK fusion detection without requiring prior knowledge of fusion partners for any solid tumor.
“Our goal is to develop products to help clinicians receive the right information at the right time to make the right treatment decision.”
ArcherDX is a genomic analysis firm engaged in development of RUO and IVD products
The company said that it is developing and seeking regulatory approvals for its NGS diagnostic to help solve for the under-usage of targeted therapies.
The advanced technology has been designed to enable the use of the diagnostics in community and regional settings where the lack of infrastructure and expertise to implement sophisticated genomic analysis can limit optimization of therapy for patients.
In addition, ArcherDX has recently announced a collaboration to develop its NGS-based CDx for a TRK inhibitor.
ArcherDX is a genomic analysis company engaged in developing research use only (RUO) products and in vitro diagnostic (IVD) products.
The portfolio of RUO products include VariantPlex, FusionPlex, LiquidPlex and Immunoverse, which we collectively refer to as ArcherPlex.
According to the company, IVD products currently in development for solid tumor biomarker identification and Personalised Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA.
