FDA has granted a breakthrough device designation to ArcherDx, Boulder, Colo, for its next-generation sequencing device under development as a companion diagnostic to detect neurotrophic receptor tyrosine kinase (NTRK) gene fusions that lead to the formation and growth of cancer.
ArcherDx’s next-generation sequencing technology utilizes proprietary anchored multiplex polymerase chain reaction chemistry that captures DNA, RNA, or ctDNA from blood and tissue samples regardless of the location of the tumor.
ArcherDx is developing and pursuing regulatory clearances for its next-generation sequencing diagnostic to help solve for the underutilization of targeted therapies. ArcherDx’s technology is designed to enable the use of the diagnostic in community and regional settings where the lack of infrastructure and expertise to implement sophisticated genomic analysis can limit a clinician’s ability to optimize therapy for patients through diagnosis, prognosis, and therapy selection.
“NTRK gene fusions are notoriously difficult to detect in cancer,” says Jason Myers, PhD, cofounder and chief executive officer of ArcherDx. “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.”
For more information, visit ArcherDx.