Thursday, June 13, 2024

Roche launches next-generation qPCR system to advance clinical needs in molecular diagnostics and address public health challenges

Roche announced the launch of the LightCycler PRO System based on the proven gold standard technology of the LightCycler Systems that came before it. This new system raises the bar for performance and usability while bridging the gap between translational research and in vitro diagnostics. The LightCycler PRO System further complements Roche’s molecular PCR testing portfolio, which includes solutions for a variety of healthcare professionals – from those performing research, to those testing patients for cancer, infectious diseases, and other public health challenges.

“Roche has made significant contributions in establishing and advancing PCR technology to address the needs of healthcare systems,” said Josh Lauer, Head of Molecular Labs at Roche Diagnostics. “We have listened to laboratories and hospitals, and implemented their feedback, which has driven important design improvements. Healthcare systems have experienced significant resource constraints and rapidly shifting dynamics post-pandemic. The LightCycler PRO addresses those dynamics by offering the flexibility to switch seamlessly between research and clinical applications.”

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The system will allow users to develop their own tests and will also enable a portfolio of more than 200 LightMix Modular research assays and over 60 LightMix CE-IVD assays from the Roche subsidiary, TIB Molbiol.

The system will launch in select countries by the end of 2023, with plans to launch into more countries in the near future. It will be CE-marked and have an FDA 510(k) exempt status.

Since launching the first LightCycler real-time PCR System in 1998, Roche has continued to innovate and advance qPCR systems for both laboratories and patients. qPCR refers to real-time PCR or quantitative PCR, which allows for simultaneous amplification and detection of DNA in real-time.

LightCycler qPCR systems are known for their performance and reliability, and Roche has built on this heritage to create the most versatile and capable LightCycler System to date. The LightCycler PRO System is designed and labelled for both research and IVD workflows, enabling labs to seamlessly and compliantly transition from discovery research to the testing of patient clinical samples.
Enhancements such as the new vapour chamber for enhanced temperature uniformity across the block, new and improved software algorithms, and the completely updated software and user interface, make this our most advanced LightCycler System ever. Adding in the portfolio of over 200 LightMix research assays and over 60 LightMix CE-IVD assays creates a unique and powerful qPCR solution for a variety of labs.

SOURCE: PRNewswire

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