ArcherDX’s Personalized Cancer Monitoring (PCM) Tech Gets FDA Breakthrough Device Designation

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Genetic testing concept, DNA icon, medical doctor, isolated on white
Genetic testing concept with DNA icon and words on a screen and a medical doctor touching a button, isolated on white background

Molecular diagnostics company ArcherDX announced it has received a breakthrough device designation from the FDA for it Personalized Cancer Monitoring (PCM) technology, a customizable minimally invasive tool for early-stage cancer treatment and recurrence monitoring.

“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,” said Jason Myers, CEO and co-founder of ArcherDX in a press release. “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.”

According to the company, PCM is designed to provide clinicians in a range of healthcare settings with access to important genomic information that can help them deliver care to patients both quick and more cost effectively. It should particularly aid community hospitals and labs for which this kind of data is not typically available.

To further refine its offerings, ArcherDX has an existing collaboration with a research study being conduct by Cancer Research UK called Tracking Cancer Evolution through therapy (Rx), known as TRACERx. Investigators in that effort, led by Prof. Charles Swanton, group leader, University College London (UCL), and the Francis Crick Institute, and Dr. Christopher Abbosh, principal clinical fellow at UCL are using ArcherDX’s technology to detect low-volume minimal residual disease at high levels of sensitivity. Such information and advances in detecting and monitoring cancer will help TRACERx researchers reach the goal of a more personalized approach to developing cancer treatments.

The PCM breakthrough designation is the second for ArCherDX. It’s pan-solid tumor test STRATAFIDE uses sequencing technology and can use both tissue and blood and is targeted for use at local hospitals or regional reference laboratories.

The designation of PCM as a breakthrough device caps a busy week for Boulder, CO-based ArcherDX. Late last week, the company announced it had signed a non-exclusive partnership with Illumina through which the companies will co-market future ArcherDX in vitro diagnostic (IVD) tests used with Illumina’s NextSeq 550Dx and MiSeq Dx sequencing systems.

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