The Digital LightCycler System is a next-generation digital PCR system that helps clinical researchers better understand the nature of a patient’s cancer, genetic disease or infection.
The new system has the potential to find and quantify ultra-rare, hard to detect mutations, leading to early diagnosis and treatment strategies.
The Digital LightCycler System is designed for laboratories performing highly sensitive and precise DNA and RNA analysis in areas such as oncology and infectious diseases.
Basel, 23 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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.
About the Digital LightCycler System
The Digital LightCycler System is the first digital PCR (dPCR) system from Roche and is intended for in-vitro diagnostic (IVD) testing. It performs absolute quantification of DNA and RNA targets using PCR technology. The Digital LightCycler System provides flexibility for laboratories through three unique reaction plates allowing customisation of the sample volumes used, the number of times a sample is partitioned (divided), and how many different tests can be run on a single sample (known as multiplexing). The system also features an easy workflow, moving from sample to results efficiently.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan