Bio-Rad Introduces New Digital PCR Assays for Human Copy Number Variation and Mutation Detection

These new predesigned assays for mutation detection and copy number variation (CNV) have been experimentally validated to provide single-copy PCR resolution without a standard curve.

Droplet Digital PCR (ddPCR™) technology provides an absolute measure of target DNA molecules. Researchers can use ddPCR assays to accelerate discovery and enable new research strategies for inherited disorders, cancer, and infectious diseases.

"We are excited because these are the first assays that have been made available as fully validated for digital PCR,” said Richard Kurtz, marketing manager of the Gene Expression Division at Bio-Rad. “These predesigned assays remove the burden of assay design and make digital PCR even easier for our customers.”

In this first release, Bio-Rad offers its customers 14 mutation detection assays with matching wild-type assays for biologically relevant and highly prevalent cancer mutation targets chosen from the COSMIC database. Commonly studied cancer gene mutations such as BRAF V600E and EGFR T790M are among the first set of assays available.

The assays, combined with the sensitivity of Bio-Rad’s ddPCR system, are capable of detecting a single mutant copy in a background of 2,000 or more wild-type molecules (0.05% mutation frequency). The precision of ddPCR also enables cancer researchers to discriminate small-fold copy number changes with the 62 assays targeting common cancer genes and two reference target assays now available.

Bio-Rad has partnered with Biogazelle, a qPCR data analysis and services company, and Integrated DNA Technologies (IDT), a world-class manufacturer of oligonucleotides, to design, optimize, and experimentally validate the assays. The PrimePCR ddPCR assays employ universal cycling conditions and do not require optimization. Primer specificity has been validated by next-generation sequencing, and all assays have been validated on Bio-Rad’s QX100™ Droplet Digital PCR system.