ArcherDX recently said it received FDA breakthrough device designation for its next-generation sequencing device.
The NGS device is designed as a companion diagnostic to detect neurotrophic receptor tyrosine kinase gene fusions that can lead to the formation and growth of cancer. ArcherDX’s technology uses Multiplex PCR chemistry that captures DNA, RNA or ctDNA from blood and tissue samples regardless of where the tumor is located.
The company is currently developing and pursuing regulatory clearances for its NGS technology for targeted therapies.
“NTRK gene fusions are notoriously difficult to detect in cancer. 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,” CEO and co-founder Jason Myers said in a news release. “Our goal is to develop products to help clinicians receive the right information at the right time to make the right treatment decision.”
ArcherDX said its diagnostic technology is also designed to be used in community and regional settings where the lack of infrastructure and expertise to implement sophisticated genomic analysts limits the ability to optimize therapy for patients through diagnosis, prognosis and therapy selection.