Roche has launched the Digital LightCycler System, its first digital polymerase chain reaction (PCR) system, to help clinical researchers ‘better understand’ patients’ cancer, genetic diseases or infections.
The new system has the potential to find and quantify ultra-rare, hard-to-detect mutations by allowing researchers to divide DNA and RNA from an already extracted clinical sample into as many as 100,000 microscopic individual reactions. The system can then perform PCR and produce ‘highly sophisticated’ data analysis on the results.
Commenting on the launch, Thomas Schinecker, chief executive officer of Roche Diagnostics, said: “Understanding the hidden characteristics of serious diseases is fundamental for ensuring that the most effective treatment is selected for each patient.
“The Digital LightCycler System will support clinical researchers and laboratories in identifying rare and emerging disease mutations. This can be instrumental in early diagnosis and therapy decisions.”
For areas such as oncology and infectious disease, the company said the system provides ‘new opportunities’ for researchers beyond the abilities of traditional PCR technology, leading to early diagnosis and treatment strategies.
The system is hoped to provide laboratories performing highly sensitive and precise DNA and RNA analysis with flexibility through three unique reaction plates, including allowing customisation of the sample volumes used, the number of times a sample is divided and how many different tests can be run on a single sample, known as multiplexing.
The system will be available in 15 countries worldwide in 2022 with plans to launch in more countries in the near future, the company said. The system will be CE-marked and has a US Food and Drug Administration (FDA) 510(k) exempt status.
