FDA has designated the personalized cancer monitoring technology from ArcherDx, Boulder, Colo, as a breakthrough device. The technology is a bespoke, minimally invasive, and highly sensitive product intended for monitoring early-stage cancer treatment and for recurrence surveillance.
ArcherDx’s technology will offer healthcare providers across community and academic care settings access to genomic information in their laboratory, saving time and allowing world-class, cost-effective care locally.
The goal of FDA’s breakthrough devices program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving standards consistent with FDA’s mission to protect and promote public health. The program will provide ArcherDx with enhanced communication with the agency regarding technology validation and clinical trial protocols, and could expedite the review process.
“Fewer than 1% of cancer patients receive any genomic profiling for the monitoring of their cancer,” says Jason Myers, cofounder and CEO of ArcherDx. “Millions of individuals who undergo cancer treatment—and the millions more who survive and achieve remission—need a sensitive, personalized means of detecting relapse earlier. We believe our bespoke product can improve both therapy monitoring and recurrence surveillance, and given the substantial need, we look forward to additional collaborative interaction with regulators to deliver our personalized cancer monitoring product to patients as soon as possible.”
For more information, visit ArcherDx.