Roche Launches Next-Generation Digital PCR System
|
By LabMedica International staff writers Posted on 02 Sep 2022 |
|
Roche Diagnostics (Basel, Switzerland) has launched its first digital polymerase chain reaction (PCR) system, the Digital LightCycler System that detects disease and is designed to accurately quantify trace amounts of specific DNA and RNA targets not typically detectable by conventional PCR methods. The next-generation 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.
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. The Digital LightCycler System provides flexibility for laboratories through three unique reaction plates allowing customization 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.
The Digital LightCycler System is intended for in-vitro diagnostic (IVD) testing and adds to Roche’s PCR ecosystem, building 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.
"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."
Related Links:
Roche Diagnostics
Latest Molecular Diagnostics News
- New Test Delivers Four Prenatal Genetic Screens from One Blood Sample
- Point-of-Care Molecular Technology Promises Transformative Shift in Oncology
- Multiplex PCR Test Differentiates Four Causes of Ulcerative Skin Lesions
- Blood Test Guides Patient Selection for Radiopharmaceutical Therapy in Prostate Cancer
- New Biomarker Helps Guide Combination Therapy for Treatment-Resistant Breast Cancer
- Blood-Based Gene Expression Test Detects Early Pancreatic Cancer
- Blood-Based Biomarker Panel Outperforms Existing Liver Disease Tests
- Fully Automated Test Advances Hepatitis D Diagnosis and Monitoring
- HPV Assay Gains Expanded CE Mark for Self-Collected Vaginal Samples
- Blood Test Achieves Improved Detection of Advanced Precancerous Colorectal Lesions
- Community-Based Genetic Screening Reaches Rural and Vulnerable Populations
- Blood and Urine Liquid Biopsy Detects Early Colorectal Cancer Mutations
- Epigenetic Profiling Could Refine Prognosis in Acute Myeloid Leukemia
- Genetic Risk Score Supports Diagnosis and Prognosis in Idiopathic Pulmonary Fibrosis
- AI Reveals Immune Response Biomarkers Linked to Ebola Survival
- Extracellular Vesicle Marker Identifies Early Lung Adenocarcinoma and Predicts Recurrence
Channels
Clinical Chemistry
view channel
Preoperative Blood Test Predicts Colorectal Cancer Recurrence and Metastasis
Cancer cells require large amounts of nutrients to grow and proliferate, and amino acids support key processes including protein formation, energy production, and DNA synthesis. Colorectal cancer is marked... Read more
New Machine-Learning Equation Improves LDL Cholesterol Assessment
Accurate assessment of low-density lipoprotein (LDL) cholesterol is central to cardiovascular risk management, yet calculation methods can underestimate values in some patients. Laboratories widely use... Read more
Hematology
view channel
New Marker Helps Detect Aggressive Multiple Myeloma Earlier
Multiple myeloma is an incurable malignancy of plasma cells and the second most common blood cancer worldwide, with more than 188,000 new cases each year. Although therapies have advanced, most patients... Read more
New Biomarkers Predict Resistance to Targeted Therapy in Rare Blood Cancer
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare and aggressive leukemia with limited treatment options and a poor prognosis. Although tagraxofusp is the first approved targeted therapy for... Read more
Immunology
view channel
Ultrasensitive Blood Test Detects Sjögren’s Signature Years Before Diagnosis
Sjögren’s disease is a common autoimmune condition that can be difficult to recognize early, leading to delayed diagnosis and persistent symptom burden. It affects around half a million people in the UK... Read more
New Assays Expand Cytokine Testing for Transplant and Immunocompromised Patients
Eurofins Viracor has introduced three plasma-based assays—CXCL9 (Test Code 33607), CXCL10 (Test Code 33609), and interleukin-18 (IL-18) (Test Code 33611)—expanding its immunology testing menu for transplant... Read more
Microbiology
view channel
Syndromic GI Panel Detects Cyclospora for Rapid Case Confirmation
U.S. health authorities have reported a rapid increase in cyclosporiasis since May 2026, with more than 1,600 confirmed infections and thousands of additional suspected cases under investigation.... Read more
Rapid Panel Identifies Gram-Negative Pathogens and Resistance Markers in Bloodstream Infections
Bloodstream infections require rapid identification of causative pathogens and resistance mechanisms to guide effective therapy. Delays in profiling gram-negative organisms, which are frequently associated... Read more
Pathology
view channel
Digital Pathology Tool Predicts Breast Cancer Outcomes and Therapy Response
Breast cancer prognosis often depends on microscopic assessment of tumor architecture, a process that can be subjective and lead to variable predictions across patient groups. Quantitative measures that... Read more
AI Bone Marrow Mapping Provides New Tool to Track Blood Cancer Severity
Myelodysplastic neoplasms, a group of blood cancers that primarily affect older adults, are challenging to stage and monitor, often requiring repeated bone marrow biopsies that can yield uncertain interpretations.... Read more
Technology
view channel
Training Device Improves Accuracy of Pooled Molecular Diagnostics
High-throughput molecular diagnostics have transformed infectious disease detection, but many workflows remain difficult to execute accurately without extensive training. Sample pooling can cut per‑test... Read more
New CE-Certified Software Advances Whole-Genome Cancer Testing
European hospitals are increasingly using comprehensive tumor genomics to guide therapy, but routine whole genome sequencing (WGS) requires validated, regulation-compliant workflows. A newly CE-certified... Read more
National Rare Disease Registry Standardizes Genetic and Clinical Data for Coordinated Care
Rare diseases collectively impose a significant clinical burden despite their individual rarity, often involving multisystem presentations and prolonged diagnostic journeys. Limited specialist expertise... Read more
Industry
view channel
Tempus to Acquire Personalis in $1.5 Billion Precision Oncology Deal
Tempus AI, Inc. (Chicago, IL, USA) has entered into a definitive agreement to acquire Personalis, Inc. (Fremont, CA, USA), expanding its capabilities in molecular residual disease (MRD) testing and cancer... Read more
