Wednesday January 15, 2020 0 comments
BOULDER -- ArcherDX, Inc. announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Personalized Cancer Monitoring (PCM) technology, a bespoke, minimally-invasive and highly-sensitive product intended for early-stage cancer treatment monitoring and recurrence surveillance.
ArcherDX said its technology enables healthcare providers across community and academic care settings access to genomic information in their laboratory, saving critical time and allowing world-class, cost-effective care locally.
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving standards, consistent with the FDA's mission to protect and promote public health.
The program will provide ArcherDX with enhanced communication with the FDA 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,” said Jason Myers, Archer DX co-founder and CEO.
“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 PCM product to patients as soon as possible."
As part of an on-going collaboration, TRACERx investigators, led by Professor Charles Swanton, Group Leader, UCL and the Francis Crick Institute, and Dr. Christopher Abbosh, Principal Clinical Fellow, UCL, are utilizing ArcherDX's technology to detect low-volume minimal residual disease at high levels of sensitivity to help achieve TRACERx's goal of a more personalized approach to developing cancer treatments.
The PCM Breakthrough designation follows Breakthrough Device Designation for ArcherDX's STRATAFIDE™ which, upon approval, would be the first pan-solid tumor device employing genomic sequencing testing technology to accept both tissue and blood that can be used in local hospital or regional reference laboratories.