SWITZERLAND – 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.
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.”
According to the company’s press release, the new Digital LightCycler 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 a ‘highly sophisticated’ data analysis on the results.
Aimed at areas of oncology and infectious disease, the system provides new opportunities for researchers beyond what traditional PCR technology can achieve.
The system is hoped to provide laboratories performing highly sensitive and precise DNA and RNA analysis with flexibility through three unique reaction plates.
It also allows customization 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 detects disease and is designed to accurately quantify trace amounts of specific DNA and RNA targets not typically detectable by conventional PCR methods.
The new Digital LightCycler 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.
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 analyses.
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.
Also, in August, Roche announced a collaboration with Cend therapeutics to evaluate CEND-1 in combination with Roche’s Tecentriq (atezolizumab), and standard-of-care chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
Roche’s Tecentriq is a cancer immunotherapy that has the potential to be used in combination with other immunotherapies, targeted medicines, and various chemotherapies across a broad range of cancers.
The company recently announced positive results from a phase 3 study evaluating a subcutaneous formulation of Tecentriq in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed, compared to Tecentriq as an intravenous dose.
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