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# Personal Cancer Monitor Granted Breakthrough Status
- URL: https://www.fdaweb.com/personal-cancer-monitor-granted-breakthrough-status/
- Published: 2020-01-14T12:00:00.000Z
- Updated: 2026-09-14T15:58:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145847

FDA has granted ArcherDX a breakthrough device designation for its Personalized Cancer Monitoring technology for early-stage cancer treatment monitoring and recurrence surveillance. The device is intended to enable healthcare providers across community and academic care settings access to genomic information in their laboratory. The company says that fewer than 1% of cancer patients receive any genomic profiling for the monitoring of their cancer. The device combines ArcherDX’s Anchored Multiplexed PCR chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software to improve genetic mutation identification and discovery.