The next-generation digital PCR system has been designed to accurately quantify specific DNA and RNA targets that are not usually detectable using conventional PCR methods.
It allows researchers to detect and quantify ultra-rare mutations, which are hard to identify. This will help in early disease diagnosis and selection of treatment strategies.
Featuring an easy workflow, the diagnostics platform has been developed for laboratories that conduct precise DNA and RNA analysis in oncology and infectious disease areas.
Using the system, clinical researchers will be able to divide DNA and RNA from an already extracted clinical sample into as many as 100,000 microscopic individual reactions.
The system will help researchers better understand a patient’s cancer, genetic disease or infection.
Roche Diagnostics CEO Thomas Schinecker 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.”
The system will be available in 15 countries this year, and more countries will follow.
It has an FDA 510(k) exempt status and will be CE-marked.
The Digital LightCycler System’s launch adds to the company’s PCR ecosystem.
Recently, Roche launched the Elecsys IGRA SARS-CoV-2 diagnostic test in countries accepting the CE mark.
The new test will help provide a better understanding of the body’s immune response to SARS-CoV-2 infection and vaccination.