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Roche Diagnostics

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Next-Generation qPCR System Enhances Capabilities for Accurate Patient Diagnosis and Effective Clinical Decisions

By LabMedica International staff writers
Posted on 28 Nov 2023
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Image: The LightCycler PRO System delivers accuracy and flexibility to research and clinical diagnostic laboratories (Photo courtesy of Roche)
Image: The LightCycler PRO System delivers accuracy and flexibility to research and clinical diagnostic laboratories (Photo courtesy of Roche)

In response to the evolving needs of healthcare systems, particularly post-pandemic, a next-generation qPCR system offers the flexibility to switch seamlessly between research and clinical applications. The new system with key features such as gold standard technology essential for accurate patient diagnosis and making informed clinical decisions, can aid advancement of personalized healthcare and enhancing preparedness for outbreaks.

Roche Diagnostics (Basel, Switzerland) has launched the LightCycler PRO System which builds upon the proven gold standard technology of the LightCycler real-time PCR Systems, a product line being developed by Roche since the introduction of their first system in 1998. Real-time PCR, or qPCR, is a method that enables simultaneous amplification and detection of DNA in real-time. The LightCycler systems are renowned for their dependable performance, and the LightCycler PRO System is the most advanced and adaptable iteration yet. It is uniquely designed for both research and in vitro diagnostic (IVD) workflows, allowing laboratories to transition smoothly from research to clinical testing of patient samples.

The LightCycler PRO System incorporates several enhancements, such as a new vapor chamber that ensures uniform temperature distribution, improved software algorithms, and a completely revamped software and user interface. These upgrades make it the most sophisticated LightCycler System Roche has ever released. This addition to Roche’s molecular PCR testing range offers tools for a wide array of professionals, from researchers to those conducting patient tests for conditions like cancer and infectious diseases. The system enables the development of custom tests and supports more than 200 LightMix Modular research assays and over 60 LightMix CE-IVD assays from Roche’s subsidiary, TIB Molbiol. Scheduled to launch in select countries by the end of 2023, the system will be CE-marked and have an FDA 510(k) exempt status, with further expansion into more countries on the cards.

“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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