Bio-Rad’s digital PCR technology eliminates dependence on standard curves by partitioning samples into thousands of droplets and using Poisson statistics to count target molecules directly, enabling high-sensitivity detection of rare variants and low-abundance targets. Marwan A. Alsarraj explains ddPCR’s mechanics and its growing role in cell and gene therapy analytics. The technology reduces competition between sequences in bulk PCR and increases precision for single-nucleotide variant detection in complex backgrounds. Labs adopting ddPCR can improve assay reproducibility and absolute quantification critical to viral vector dosing, CAR-T product release, and sensitive MRD monitoring. Key challenges remain scale, cost per sample, and assay design standardization across labs. As regulatory agencies demand more precise potency and impurity assays in advanced therapy submissions, ddPCR adoption is likely to accelerate in both R&D and regulated testing environments.