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

Rhea-AI Summary

Roche (SIX: RO, ROG; OTCQX: RHHBY) launches the LightCycler PRO System, an advanced qPCR technology designed for clinical diagnostics and research. The system aims to advance personalized healthcare and support outbreak readiness, offering agility and flexibility for translational research and diagnostics. It utilizes gold standard technology for quality, precision, and reliability, critical for accurate patient diagnosis and clinical decisions.

Positive

• The LightCycler PRO System is designed to address the needs of healthcare systems, offering flexibility to switch seamlessly between research and clinical applications.
• 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.

Negative

• None.

• The LightCycler PRO System is designed to be the most advanced qPCR technology for both clinical diagnostics and research.
• The new system will advance personalised healthcare and support outbreak readiness by delivering agility and flexibility for translational research and diagnostics.
• The innovative features of the system utilises gold standard technology for quality, precision and reliability - capabilities critical for accurate patient diagnosis and effective clinical decisions.

PLEASANTON, Calif., Nov. 20, 2023 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 launches next-generation qPCR system to advance clinical needs in molecular diagnostics.

"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."

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.

About the LightCycler^® PRO
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. 

About Roche 
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

For further information please contact:

Elizabeth Baxter, Head of Communications, Molecular Labs & Roche Diagnostics Solutions Portfolio Centre of Excellence
+1925.523.8812
Elizabeth.Baxter@roche.com

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SOURCE Roche Molecular Systems, Inc.

FAQ

What is the purpose of the LightCycler PRO System?

The purpose of the LightCycler PRO System is to advance personalized healthcare and support outbreak readiness by offering agility and flexibility for translational research and diagnostics.

What are the key features of the LightCycler PRO System?

The system utilizes gold standard technology for quality, precision, and reliability, critical for accurate patient diagnosis and clinical decisions. It allows users to develop their own tests and enables a portfolio of more than 200 LightMix Modular research assays and over 60 LightMix CE-IVD assays.

When will the system be launched?

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.