Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) today announced the launch of new PrimePCR Assays for Droplet Digital PCR (ddPCR). This release expands Bio-Rad’s current offering of predesigned and fully wet-lab validated assays by an additional 100 assays for copy number variation (CNV) and 92 assays for mutation detection. Bio-Rad will also be adding 5,620 mutation detection assays that were created using the same algorithms and design rules as the wet-lab validated assays.

Bio-Rad’s ddPCR technology provides an absolute measure of target DNA molecules without the need for a standard curve. Together with PrimePCR Mutation Detection Assays, this technology enables detection of one mutant molecule in a background of 2,000 wild-type molecules. Measuring these extremely low levels of mutation abundance could lead to the development of new, less invasive and more sensitive diagnostics. In addition, the high precision and absolute quantification made possible by PrimePCR ddPCR Assays enable the quantitative discrimination required to resolve small fold changes in gene copy numbers for CNV analysis.

Highly studied gene targets
Among the genes that can now be targeted using PrimePCR ddPCR Assays is paired box gene 2 (PAX2), a CNV gene target that is suspected to have both oncogenic and tumor suppression functions in ovarian cancers. Another notable CNV assay released as part of this launch detects the neurexin-1-alpha gene (NRXN1), which has been linked to a range of neurodevelopmental disorders, including autism spectrum disorders, schizophrenia, and intellectual disability.

The new mutation detection PrimePCR ddPCR Assays include those for fms-related tyrosine kinase (FLT) mutations that are observed in acute myeloid leukemia (AML) patients. Mutations in the fms-like tyrosine kinase 3 (FLT3) gene represent one of the most frequently encountered and clinically challenging classes of AML mutations. This release also includes several assays that detect mutations in the neuroblastoma RAS (NRAS) gene, including the G12V mutation that has recently been linked to poor prognosis in malignant melanoma.

PrimePCR ddPCR Assays are compatible with all Bio-Rad Droplet Digital PCR Systems, including the QX200 AutoDG Droplet Digital PCR System.

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