Roche Molecular Systems

Automation solutions that consolidate multiple laboratory disciplines into a single, interoperable core lab to increase efficiency, throughput and clinical decision support.

Mobile application enabling users to register home test results, scan test identifiers and generate a secure personal record or a privacy-preserving verification token for events or workplaces.

Compact integrated molecular system designed to automate, consolidate and standardize nucleic acid testing with continuous loading, prioritization and a walk-away workflow for moderate laboratory throughput.

Sequencing platforms and accompanying high-quality sample preparation reagents and assays for research and translational/clinical NGS applications.

The cobas® b 123 POC system is a fully automated point-of-care system for in vitro measurement of pH, blood gases, electrolytes, hematocrit, metabolites, total hemoglobin and its derivatives, oxygen saturation, and neonatal bilirubin. It is designed for fast and easy blood gas testing with flexible configurations and a throughput of up to 30 samples per hour, suitable for ICU, ER, NICU, OR, dialysis units, or laboratory use.

A multiplex respiratory bacterial panel detecting Bordetella pertussis, B. parapertussis, and B. holmesii, designed for use on the cobas® liat system with CE-IVD clearance.

Boost your efficiency with fast analytical units, intelligent sample routing, and short assay incubation times.

The cobas eplex blood culture identification gram-negative (BCID-GN) panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the cobas eplex instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-negative bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture.

PCR quantitation of Epstein-Barr Virus (EBV) on the cobas® 5800/6800/8800 Systems.

Highly specific and sensitive serology test to detect HIV infections using ECL technology for reliable results.

Highly specific and sensitive serology test to detect Hepatitis C Virus infections using ECL technology for reliable results.

The cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® Liat® System is an automated, real-time RT-PCR assay intended for the rapid in vitro qualitative detection of SARS-CoV-2 in nasal and nasopharyngeal swab specimens from symptomatic and asymptomatic individuals. It provides results within 20 minutes and is designed for use in Point-of-Care settings.

Immunoassay for the quantitative determination of antibodies to the SARS-CoV-2 spike protein.

The BenchMark ULTRA PLUS instrument is intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry, immunocytochemistry, or in situ hybridization reagents for in vitro diagnostic use. It fully automates baking, deparaffinization, and staining for qualitative or semi quantitative detection of analytes as an aid in diagnosis by pathologists.

Designed with features to make accurate self-testing as easy and as repeatable as possible, including full-color display with easy-to-use on-screen instructions.

The BenchMark Special Stains system automatically stains histology specimens with reagents for in vitro diagnostics, enhancing workflow with proven technology.

For in vitro diagnostic use to detect ALK protein in tumor tissues.

A high performance, flexible, and automated molecular diagnostic system that performs sample preparation, nucleic acid extraction, and multiplex real-time PCR amplification and detection for molecular labs.

A flexible and efficient high-throughput multiplex PCR system with minimal technician interaction and a time to results of approximately 3 hours.

The cobas® prime pre-analytical system automatically prepares samples for molecular diagnostic testing, minimizing manual tasks to support workflow automation.

The cobas eplex blood culture identification gram-negative (BCID-GN) panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the cobas eplex instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-negative bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture.

The cobas® p 612 pre-analytical system is a fully automated solution for early-stage patient sample quality inspection for the optimization of lab workflows.

The cobas s 201 system is a complete NAT solution supporting the central needs of blood screening labs, combining the efficiency and reliability of real-time PCR technology with modular automation, ready-to-use reagents and a robust menu selection.

The industrys leading instruments converge to form a single solution that transforms your operation into a laboratory of the future. This fully automated system consolidates, integrates and standardizes the pre-analytical process to streamline lab operations.

Roche's first whole blood PCR test for blood screening that detects 4 species of Babesia (B. microti, B. duncani, B. divergents, B venatorum) that cause disease in humans.

Precise quantitation of B19V DNA and high sensitivity for HAV RNA for detecting B19V genotypes 1, 2, and 3, and hepatitis A genotypes I, II and III. Also utilizes a World Health Organization (WHO) traceable international standard to provide quantitative results for B19V.

The cobas® b 123 POC system is a fully automated point-of-care system for in vitro measurement of pH, blood gases, electrolytes, hematocrit, metabolites, total hemoglobin and its derivatives, oxygen saturation, and neonatal bilirubin. It is designed for fast and easy blood gas testing with flexible configurations and a throughput of up to 30 samples per hour, suitable for ICU, ER, NICU, OR, dialysis units, or laboratory use.

A fully automated, integrated, standardised, and easy-to-use clinical mass spectrometry solution with high throughput and random access, designed to work in combination with cobas® pro integrated solutions.

The LightCycler® PRO system combines instrumentation, consumables, reagents, and data management to support a semi-automated workflow for polymerase chain reaction-based nucleic acid testing. It delivers accurate real-time PCR results with improved user experience, leveraging the robustness of the LightCycler® 480 technology.

Highly specific and sensitive serology test to detect Hepatitis C Virus infections using ECL technology for reliable results.

A user-friendly hand-held system for point-of-care glucose testing and monitoring in hospitals.

Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems. Automated multiplex real-time RT-PCR assay for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus RNA in nasal and nasopharyngeal swab specimens.

Utility channel for third-party tests and laboratory-developed tests (LDTs) compatible with cobas® 5800/6800/8800 Systems, available in countries accepting CE-mark and FDA approval.

The cobas h 232 is an in vitro diagnostic instrument intended for the quantitative evaluation of immunoassays using the Roche CARDIAC test strips in human whole blood. The cobas h 232 is intended for near-patient testing. Not for self-testing.

The cobas® c 703 analytical unit delivers high-throughput clinical chemistry testing, performing up to 2000 tests per hour and featuring 70 reagent positions.

The cobas® u 411 urine analyser is a semiautomated system designed for reliable and efficient urinalysis testing to aid in assessing renal, urinary, hepatic and metabolic disorders.

A high throughput coagulation analyser designed for labs with higher testing and automated workflow needs, supporting continuous loading and integration with total laboratory automation.

An innovative, customizable multiplex PCR solution designed to streamline respiratory testing in laboratories, offering reassurance and reliability in patient results. It enables simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) in nasopharyngeal swab specimens.

An innovative, customizable multiplex PCR solution designed to streamline respiratory testing in laboratories, offering reassurance and reliability in patient results. It enables simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) in nasopharyngeal swab specimens.

The LightCycler® PRO system combines instrumentation, consumables, reagents, and data management to support a semi-automated workflow for polymerase chain reaction-based nucleic acid testing. It delivers accurate real-time PCR results with improved user experience, leveraging the robustness of the LightCycler® 480 technology.

A PCR test panel that can differentiate between SARS-CoV-2 and other common respiratory viral and bacterial pathogens, providing rapid and comprehensive testing results in under 3 hours.

A qualitative in-vitro nucleic acid test for the direct detection of Plasmodium DNA and RNA in whole blood samples.

Unleash the true power of digital PCR.

A software platform intended to provide bi-directional, standardized and secure data integration and communication between laboratory data sources and cloud-based products. Not intended as a primary diagnostic tool or to interpret clinical data.

In vitro test for the quantitative determination of glucose in human serum, plasma, urine and cerebrospinal fluid (CSF) on cobas c and COBAS INTEGRA systems.

Intended for qualitative detection of PD-L1 protein in formalin-fixed, paraffin-embedded non-small cell lung cancer, urothelial carcinoma, and other tumor tissues stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument.

PRAME (PReferentially expressed Antigen in MElanoma) is a tumor biomarker expressed in most cutaneous and ocular melanomas. It is an IVD product for in vitro diagnostic use.

The only test approved to identify HER2-low breast cancer patients, helping match more women with highly effective personalized therapies.

A respiratory pathogen panel with expanded targets for comprehensive syndromic testing, designed for use on the cobas® eplex system.

A comprehensive, fast syndromic testing system providing broad pathogen coverage and rapid results in less than 2 hours, designed for high-risk patients with configurable panels.

A multiplex CLIA-waived assay delivering fast, accurate results for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and mycoplasma genitalium (Mgen) at the point of care, enabling confident sexual health testing.

A rapid test for Streptococcus A designed for use on the cobas® liat system with CE-IVD clearance.

The cobas 5800 system supports an automated and integrated workflow to run PCR-based nucleic acid testing for use by trained professionals in laboratory settings.

cobas® connection modules allow the connection of the standalone automation systems to analytics and post-analytics through a fast transportation system.

A module to physically connect pre-analytical instruments to the cobas® systems, enhancing workflow efficiency in molecular labs.

Directly detect West Nile Virus RNA in human plasma early in the infection lifecycle for both WNV lineages 1 and 2.

Test to reliably monitor CMV infection and provide comparable and reproducible viral load results for transplant patients.

Detects emerging zoonotic pathogen in donor blood, provides sensitive, broad coverage of HEV genotypes 1-4 to help increase the safety of the blood supply.

The cobas click system is an intuitive, next-generation Point of Care solution for HbA1c, lipids, and CRP testing with unique, high-performing test discs.

cobas pure integrated solutions combines clinical chemistry, immunoassay, and ion-selective electrode (ISE) testing on a footprint of just 2 square meters.

An automated rapid multiplex real-time RT-PCR test for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and RSV nucleic acids in nasal and nasopharyngeal swab specimens from symptomatic individuals.

Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems. It is an automated, multiplex, nucleic acid test utilizing real-time PCR technology for simultaneous qualitative detection and differentiation of 12 viral respiratory infections including SARS-CoV-2 in nasopharyngeal swab specimens.

The cobas® Influenza A/B & RSV is an automated multiplex real-time RT-PCR assay for rapid qualitative detection and discrimination of Influenza A, Influenza B, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens. It is intended for use on the cobas® Liat® System and provides results in approximately 20 minutes with minimal hands-on time, authorized for use in CLIA-waived settings.

LumiraDx is designed to make testing easy, efficient and more accessible. It is a portable battery-operated system providing rapid results in 12 minutes or less, with additional assays beyond respiratory.

A rapid microfluidic immunofluorescence assay for qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 in nasal and nasopharyngeal swab samples, intended for use with the LumiraDx Platform. Provides results within 12 minutes and is authorized for point-of-care use under FDA Emergency Use Authorization.

Quantitative immunological test for the detection of cardiac troponin T in heparinized venous blood for use with the cobas h 232 instrument. Intended as an early aid in diagnosis of acute myocardial infarction and identification of patients with an elevated mortality risk. The test is intended for near-patient testing and is not for self-testing.

A multiplexed nucleic acid in vitro diagnostic test for simultaneous qualitative detection and differentiation of nucleic acids from multiple respiratory viral and bacterial organisms, including SARS-CoV-2, using nasopharyngeal swabs on the cobas® eplex Instrument.

A flexible and efficient high-throughput multiplex PCR system with minimal technician interaction and a time to results of approximately 3 hours.

The cobas4 eplex system delivers rapid, multiplex diagnostics with sample-to-answer automation, LIS integration, and scalable design.

An automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time PCR for the direct detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) nucleic acid in male urine and vaginal swabs, intended as an aid in the diagnosis of urogenital infections in both symptomatic and asymptomatic individuals.

The cobas4 5800 system makes automation, consolidation, integration and standardization more accessible than ever before.

The cobas eplex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on cobas eplex Instrument for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture samples.

Detects and discriminates the most critical viral targets in one easy-to-use assay for HIV-1 Group M, HIV-1 Group O, HIV-2, HCV and HBV. Enables donor screening laboratories to reliably test for 3 viruses and 5 critical viral targets with a single assay, boosting operational efficiency by eliminating the need for additional discriminatory testing.

A qualitative in-vitro test for the direct detection of chikungunya virus (CHIKV) RNA and dengue virus (DENV) serotypes 1-4 CHIKV WA, CHIKV ECSA, CHIKV Asian RNA in human plasma.

Qualitative in vitro test for detection of high-risk Human Papillomavirus types on the cobas® 5800/6800/8800 Systems.

The cobas® liat analyser delivers gold-standard PCR testing at the point of care, providing quick, targeted near-patient testing with actionable results in 20 minutes. It supports frontline multiplex assays for differential diagnosis of SARS-CoV-2, Influenza A/B and RSV.

The cobas® liat analyser delivers gold-standard PCR testing at the point of care, providing quick, targeted near-patient testing with actionable results in 20 minutes. It supports frontline multiplex assays for differential diagnosis of SARS-CoV-2, Influenza A/B and RSV.

LightCycler4 PRO integrates innovative technology and Roche manufacturing to deliver accurate real-time PCR results.

navify® Analytics for Molecular Lab provides operational insights for customers with the cobas® 6800, cobas® 5800, cobas® 8800 molecular diagnostic instruments, including dashboards for test volumes, errors, instrument efficiency, positivity rate, and quality control.

A digital analytics platform providing operational insights for various aspects of the laboratory including order, sample, and test volumes, turnaround times, rerun result analysis, manual validation analysis, instrument utilization, serum index analysis, test result analysis, QC analysis, and reagent usage analysis.

The MagNA Pure 96 system is a high-throughput instrument for automated nucleic acid purification, increasing laboratory productivity.

US FDA Approved donor screening test for Zika virus, detects Asian and African strains of Zika virus with a proven high clinical sensitivity track record during the outbreak in the Americas.

Immunoassay for the qualitative determination of HIV p24 antigen and antibodies to HIV.