Roche. (8/23/22). "Press Release: Roche Launches a Digital PCR System, a Powerful New Diagnostics Platform in the Fight against Cancer and other Diseases". Basel.

	Organisation	Roche Diagnostics (Group Division)
	Group	Roche (Group)
	Product	Digital LightCycler® System
	Product 2	in vitro diagnostics (IVD)
	Person	Schinecker, Thomas (Roche 202208 CEO of Roche Diagnostics formerly 201110 President of 454 Life Sciences)

> The Digital LightCycler System is a next-generation digital PCR system that helps clinical researchers better understand the nature of a patient’s cancer, genetic disease or infection.

> The new system has the potential to find and quantify ultra-rare, hard to detect mutations, leading to early diagnosis and treatment strategies.

> The Digital LightCycler System is designed for laboratories performing highly sensitive and precise DNA and RNA analysis in areas such as oncology and infectious diseases.

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Digital LightCycler® System, Roche’s first digital polymerase chain reaction ( PCR) system. This next-generation 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 Digital LightCycler System will allow clinical 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 highly sophisticated data analysis on the results.

"Understanding the hidden characteristics of serious diseases is fundamental for ensuring that the most effective treatment is selected for each patient," said Thomas Schinecker, CEO of Roche Diagnostics. “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."

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 analysis.

Roche has made significant contributions to establish and advance PCR technology over several decades. In 1991, Roche saw the potential in PCR and invested in refining the science for use in molecular diagnostics to detect pathogens and genetic code changes that lead to diseases.

The unique capabilities of the Digital LightCycler System complement the Roche suite of widely available PCR solutions. The launch of this new system adds to this PCR ecosystem, and builds on the company’s founding legacy in PCR. Both solutions will be offered by Roche, providing a suite of molecular solutions to the healthcare community.

The system will be available in 15 countries worldwide in 2022 with plans to launch into more countries in the near future. It will be CE-marked and has an FDA 510(k) exempt status.

About the Digital LightCycler System

The Digital LightCycler System is the first digital PCR (dPCR) system from Roche and is intended for in-vitro diagnostic (IVD) testing. It performs absolute quantification of DNA and RNA targets using PCR technology. The Digital LightCycler System provides flexibility for laboratories through three unique reaction plates allowing customisation of the sample volumes used, the number of times a sample is partitioned (divided), and how many different tests can be run on a single sample (known as multiplexing). The system also features an easy workflow, moving from sample to results efficiently.

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 recognizing our endeavor 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.

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Record changed: 2023-06-05