ArcherDX announced that it has won breakthrough device designation from the FDA for its personalized cancer monitoring (PCM) technology.
Boulder, Colo.-based ArcherDX’s PCM platform is designed for minimally invasive monitoring and recurrence surveillance for early-stage cancer treatment. It is meant to offer healthcare providers access to genomic information in their laboratory.
ArcherDX also recently won a breakthrough nod from the FDA for its Stratafide pan-solid tumor device designed to employ genomic sequencing testing to accept tissue and blood that can be used in hospitals or regional reference laboratories.
“Fewer than 1% of cancer patients receive any genomic profiling for the monitoring of their cancer,” ArcherDX co-founder & CEO Jason Myers said in a news release. “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.”
