Having a full picture of disease is vital for selecting the most effective course of treatment. Since its development in the late 1980s, PCR has revolutionized the detection and diagnosis of infectious disease and cancer, but next-generation tools are taking PCR to even higher levels of precision, sensitivity, and clinical utility.

Roche—a PCR pioneer—builds on this legacy with the new Digital LightCycler® dPCR System. Purpose-built for in-vitro diagnostic testing, the powerful clinical tool accurately quantifies even trace amounts of specific DNA and RNA targets, including ultra-rare, hard-to-detect mutations not measurable by traditional PCR.

With sample prep similar to quantitative PCR, upgrading to the Digital LightCycler® dPCR System allows for similar protocols. The system features three nanowell plate configurations: High Resolution for copy number variation and human genetic disease; Universal for gene expression and transplant rejection; and High Sensitivity for cell-free DNA, oncology, and rare mutation detection. This flexibility allows the user to customize their assays based on sample volumes and how many different tests they need to run on a single sample.

Unique hexagonal-shaped nanowell partitions and a filling dye that validates partitioning give the Digital LightCycler® dPCR System the ability to handle a wide variety of extracted samples, including FFPET, cfDNA, whole blood, and more. DNA and RNA from an already-extracted clinical sample can be divided into as many as 100,000 microscopic individual reactions with the High-Resolution Plate.

Partitioning of the reaction mixtures reduces interference by PCR inhibitors and competing background DNA compared to what can be achieved with traditional PCR. The partitions allow for target sequences to be efficiently concentrated within isolated microreactors; this concentration effect in turn reduces template competition, enabling the detection of rare mutations and allowing for a higher tolerance to inhibitors present in a sample. This partitioning also allows for better precision in target quantification.

Six advanced optical channels enable a high degree of multiplexing for DNA or RNA targets. Master mixes for DNA and RNA, concentrated 5X, translate to higher sample utilization in each reaction. After amplification, the nanowells are imaged and the results analyzed by the Digital LightCycler® analysis algorithm.

For areas like oncology and infectious disease, Roche’s Digital LightCycler® dPCR System goes beyond what traditional PCR technology can achieve—providing clinicians with a better understanding of a patient’s cancer, genetic disease, or infection, and ultimately increasing the likelihood of positive outcomes.