Pharma Focus Europe

Roche launches a digital PCR system, a powerful new diagnostics platform in the fight against cancer and other diseases

Wednesday, August 24, 2022

Roche has unveiled the Digital LightCyclerⓇ System, their first digital polymerase chain reaction (PCR) system. This advanced system is specifically designed to detect diseases and accurately quantify minuscule amounts of specific DNA and RNA targets that are typically undetectable by conventional PCR methods.

With the Digital LightCycler System, clinical researchers can divide DNA and RNA extracted from clinical samples into up to 100,000 individual microscopic reactions. The system then performs PCR and conducts highly sophisticated data analysis on the obtained results.

Thomas Schinecker, CEO of Roche Diagnostics, emphasized the significance of understanding the hidden characteristics of serious diseases in order to select the most effective treatment for each patient. The Digital LightCycler System will provide support to clinical researchers and laboratories in identifying rare and emerging disease mutations, aiding in early diagnosis and treatment decisions.

In areas such as oncology and infectious diseases, this system opens up new opportunities for researchers beyond the capabilities of traditional PCR technology. It allows for the detection of ultra-rare targets, precise quantification of target DNA or RNA at a molecular level, and other high-precision analyses.

Roche has been at the forefront of advancing PCR technology for many years. Recognizing its potential, the company made substantial investments in refining the science of PCR for use in molecular diagnostics, enabling the detection of pathogens and genetic code changes associated with various diseases.

The unique capabilities of the Digital LightCycler System complement Roche's existing suite of widely available PCR solutions. This new system further expands Roche's PCR ecosystem and builds upon the company's pioneering legacy in PCR technology. Both the Digital LightCycler System and their existing solutions will be offered by Roche, providing a comprehensive suite of molecular solutions to the healthcare community.

The Digital LightCycler System will initially be available in 15 countries worldwide in 2022, with plans for further expansion into additional countries in the near future. It has obtained the CE mark and holds an FDA 510(k) exempt status, meeting the necessary regulatory requirements.

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