FDA News

FDA clears liquid biopsy test to monitor response to chronic myeloid leukemia treatment

The FDA cleared a liquid biopsy test designed to precisely and reproducibly monitor molecular response to treatment among patients with chronic myeloid leukemia.

The QXDx AutoDG ddPCR System (Bio-Rad Laboratories) — which uses Bio-Rad’s Droplet Digital polymerase chain reaction (PCR) technology — and the QXDx BCR-ABL %IS Kit are the first digital PCR products to receive FDA clearance.

The QXDx AutoDG ddPCR System is designed to be flexible, allowing users to run either FDA-cleared in vitro diagnostic tests or lab-developed tests on the platform.

“Bio-Rad is proud to announce our first FDA-cleared liquid biopsy test in oncology,” Annette Tumolo, executive vice president and president of Life Science Group at Bio-Rad Laboratories, said in a company-issued press release. “The QXDx AutoDG ddPCR System and QXDx BCR-ABL %IS Kit represent the first-ever digital PCR solution that can monitor and directly quantitate the molecular response of patients with chronic myeloid leukemia under tyrosine kinase inhibitor therapy.”

The FDA cleared a liquid biopsy test designed to precisely and reproducibly monitor molecular response to treatment among patients with chronic myeloid leukemia.

The QXDx AutoDG ddPCR System (Bio-Rad Laboratories) — which uses Bio-Rad’s Droplet Digital polymerase chain reaction (PCR) technology — and the QXDx BCR-ABL %IS Kit are the first digital PCR products to receive FDA clearance.

The QXDx AutoDG ddPCR System is designed to be flexible, allowing users to run either FDA-cleared in vitro diagnostic tests or lab-developed tests on the platform.

“Bio-Rad is proud to announce our first FDA-cleared liquid biopsy test in oncology,” Annette Tumolo, executive vice president and president of Life Science Group at Bio-Rad Laboratories, said in a company-issued press release. “The QXDx AutoDG ddPCR System and QXDx BCR-ABL %IS Kit represent the first-ever digital PCR solution that can monitor and directly quantitate the molecular response of patients with chronic myeloid leukemia under tyrosine kinase inhibitor therapy.”