FDA clears Bio-Rad’s digital-droplet PCR tests for tracking leukemia treatments

red blood cells
Bio-Rad first introduced its Droplet Digital PCR technology—which divides the PCR reaction into multiple, smaller reactions—as a research tool in 2012. (Pixabay)

Bio-Rad Laboratories has received FDA clearance for two digital PCR products designed to monitor patients’ molecular responses to tyrosine kinase inhibitor treatments in chronic myeloid leukemia.

The company’s QXDx AutoDG ddPCR system, along with its QXDx BCR-ABL %IS kit, represents Bio-Rad’s first cleared liquid biopsy test in oncology.

The current standard for monitoring treatment responses in CML patients is reverse transcription quantitative PCR, which can produce variable results when measuring low levels of the disease, according to Bio-Rad.

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The digital system and kit can more accurately help monitor residual disease, the company said. Bio-Rad first introduced its Droplet Digital PCR technology—which divides the PCR reaction into multiple, smaller reactions—as a research tool in 2012.

RELATED: Illumina, Bio-Rad to roll out single-cell genome sequencing tool

In 2017, Bio-Rad acquired RainDance Technologies, which specialized in droplet-based genomic tools and digital PCR. It also offered the low-cost, target-enriching ThunderBolts system, and tools used by labs and research institutions to investigate genetic variations in a range of diseases, as well as to research liquid biopsy.

In addition, Bio-Rad’s droplet partitioning technology is employed to isolate and barcode single cells, which are then sequenced with Illumina instruments.

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