Roche launches a digital PCR system, a powerful new diagnostics platform in the fight against cancer and other diseases

Rhea-AI Summary

Roche has launched the Digital LightCycler System, its first digital PCR platform aimed at enhancing the detection of rare mutations in cancer and infectious diseases. This new system allows laboratories to segment clinical samples into 100,000 reactions, enabling precise DNA and RNA analysis. With CE marking and FDA 510(k) exempt status, it will be available in 15 countries by the end of 2022, expanding Roche's PCR solutions portfolio. CEO Thomas Schinecker emphasized its potential for improving patient diagnosis and treatment strategies.

Positive

• Launch of the Digital LightCycler System enhances Roche's product portfolio in molecular diagnostics.
• The system could facilitate early diagnosis and treatment of cancers and infectious diseases by detecting ultra-rare mutations.
• Operational flexibility allows for partitioning samples and conducting multiple tests from a single sample.

Negative

• None.

• 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.
  
  

Basel, 23 August 2022 - 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.

Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 61 687 41 47	Nathalie Altermatt Phone: +41 61 687 43 05
Karsten Kleine Phone: +41 61 682 28 31	Nina Mählitz Phone: +41 79 327 54 74
Dr. Barbara von Schnurbein Phone: +41 61 687 89 67	Sileia Urech Phone: +41 79 935 81 48

Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com	Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com

Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com

FAQ

What is the Digital LightCycler System launched by Roche?

The Digital LightCycler System is Roche's first digital PCR system designed for accurate detection and quantification of trace DNA and RNA targets.

When was the Digital LightCycler System launched?

The Digital LightCycler System was launched on August 23, 2022.

Which countries will have access to the Digital LightCycler System?

The system will initially be available in 15 countries worldwide in 2022, with plans for broader availability.

What are the benefits of the Digital LightCycler System for clinical researchers?

It allows for the detection of ultra-rare mutations, enhancing early diagnosis and informing treatment strategies.

What regulatory status does the Digital LightCycler System hold?

The system has CE marking and is FDA 510(k) exempt, facilitating its use in laboratories.