August 24, 2022 – Roche announced the launch of the Digital LightCyclerⓇ System, Roche’s first digital polymerase chain reaction (PCR) system. This next-generation system detects disease and is designed to accurately quantify trace amounts of specific DNA and RNA targets not typically detectable by conventional PCR methods.
The Digital LightCycler System will allow clinical 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.
“Understanding the hidden characteristics of serious diseases is fundamental for ensuring that the most effective treatment is selected for each patient,” said Thomas Schinecker, CEO of Roche Diagnostics. “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 like oncology and infectious disease, the system provides new opportunities for researchers beyond what traditional PCR technology can achieve. This includes ultra-rare targets, accurately quantifying how much of the target DNA or RNA there is at a molecular level, and other high precision analysis.
Roche has made significant contributions to establish and advance PCR technology over several decades. In 1991, Roche saw the potential in PCR and invested in refining the science for use in molecular diagnostics to detect pathogens and genetic code changes that lead to diseases.
The unique capabilities of the Digital LightCycler System complement the Roche suite of widely available PCR solutions. The launch of this new system adds to this PCR ecosystem and builds on the company’s founding legacy in PCR. Both solutions will be offered by Roche, providing a suite of molecular solutions to the healthcare community.
The system will be available in 15 countries worldwide in 2022 with plans to launch into more countries in the near future. It will be CE-marked and has an FDA 510(k) exempt status.