On January 14, 2020 ArcherDX, Inc., reported 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 (Press release, ArcherDX, JAN 14, 2020, View Source [SID1234553195]). ArcherDX’s 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.
Jason Myers, ArcherDX Chief Executive Officer and co-founder said, "Fewer than 1% of cancer patients receive any genomic profiling for the monitoring of their cancer. 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, TRACERx1 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.