Liquid Biopsy Test Cleared for Use in CML

The U.S. Food and Drug Administration approved the QXDx AutoDG ddPCR System, a liquid biopsy test designed to precisely and reproducibly monitor molecular response to treatment in patients with chronic myeloid leukemia (CML). This clearance represents the first digital polymerase chain reaction (PCR) to receive approval in the U.S.

Standard monitoring of response in patients with CML includes using reverse transcription quantitative PCR. The QXDx liquid biopsy system demonstrated that it produced reliable results, even when measuring low levels of disease.

Source: Bio-Rad Laboratories press release, February 14, 2019.