Products and services

Our aim is to develop new and improved therapies and diagnostics tests and services that offer
significant benefits over existing options.

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  • Products
AMPLILINK 3.3 Series Software

AMPLILINK 3.3 Series Software

AMPLILINK Software, a Windows®-based application, is designed to deliver maximum flexibility, efficiency and integrity to your lab’s workflow – from sample input through results output. Manager the maintenance and operation of the connected COBAS® Instruments and Analysers with AMPLILINK 3.3 Series Software.

One AMPLILINK data station is capable of supporting up to 3 COBAS® AmpliPrep Instruments and 3 Analysers (combination of COBAS® AMPLICOR®, COBAS® TaqMan® and COBAS® TaqMan® 48 Analysers), together with the new cobas p 630 Instrument for pre-analytics.

 

COBAS® 4800 BRAF V600 Mutation Test

COBAS® 4800 BRAF V600 Mutation Test

A companion diagnostic for vemurafenib

The cobas® 4800 BRAF V600 Mutation Test detects the BRAF V600E mutation in formalin-fixed, paraffin-embedded (FFPET) human melanoma tissue. It is designed to help select patients for treatment with vemurafenib, an oral medicine designed to treat patients whose melanoma tumors harbor a mutated form of the BRAF gene.

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COBAS® 4800 CT/NG Test

COBAS® 4800 CT/NG Test

The cobas® 4800 CT/NG Test is an in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in specimens. The cobas® 4800 CT/NG Test will detect CT only, NG only or simultaneously detect CT and NG DNA from endocervical swab and urine specimens collected from symptomatic or asymptomatic individuals using the cobas® PCR Female Swab Sample Kit or cobas® PCR Urine Sample Kit.

The cobas® 4800 software allows the user to select only the test requested for each sample, therefore the operator only gets the results requested by the physician.

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COBAS® 4800 System

COBAS® 4800 System

The cobas® 4800 system provides a platform to perform qualitative in vitro nucleic acid amplification tests for the detection of Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG), and Human Papilloma Virus (HPV) in clinical specimens. The cobas® 4800 system integrates fully automated total nucleic acid isolation directly from primary and secondary sample tubes, automated PCR setup, and real-time PCR.

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COBAS® AmpliPrep Instrument

COBAS® AmpliPrep Instrument

The COBAS® AmpliPrep Instrument is the first true walk-away system automating the nucleic acid isolation steps of PCR testing for analysis on the COBAS® TaqMan® 48 Analyser and the COBAS® TaqMan® Analyser, contributing to enhanced productivity by hands-free operation and maximizing throughput capacity.

Ready-to-use sample preparation kits are available in combination with the IVD viral load assays (HBV, HCV, HIV-1) for the COBAS® TaqMan® Analysers. In addition, the generic Total Nucleic Acid Isolation Kit (research use only) can be used to isolate highly purified DNA and RNA from serum or plasma for PCR or other amplification technologies on various platforms.

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COBAS® AmpliPrep Total Nucleic Acid Isolation Kit

COBAS® AmpliPrep Total Nucleic Acid Isolation Kit

The COBAS® AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) is designed for the preparation of highly purified total nucleic acid from serum or plasma (collected in the anticoagulants EDTA or ACD only) on the COBAS® AmpliPrep Instrument.

The purified nucleic acid can be used in any nucleic acid amplification technology (e.g. in combination with COBAS® TaqMan® Analysers or the LightCycler® instruments). An Internal Control or Quantitation Standard (IC/QS) can be incorporated into each individual sample and is carried through the sample preparation. It compensates for loss of target and traces of potential inhibitors in the consecutive amplification step. It is the user’s responsibility to validate the performance of TNAI including the use of an IC/QS for any particular use.

 

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COBAS® AmpliPrep/COBAS® TaqMan® CMV Test

COBAS® AmpliPrep/COBAS® TaqMan® CMV Test

Dependable CMV monitoring

Improve disease management and patient care with a Roche real-time, fully automated PCR test.

A viral load test used to quantify the amount of Cytomegalovirus in human plasma of CMV infected individuals. The test is used as an aid in the management of patients at risk for CMV-infection and/or undergoing anti-viral therapy after solid organ or bone marrow transplantation.

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COBAS® AmpliPrep/COBAS® TaqMan® HBV Test v2.0

COBAS® AmpliPrep/COBAS® TaqMan® HBV Test v2.0

The COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 is an in vitro nucleic acid amplification test for the quantitation of Hepatitis B virus (HBV) in human plasma, using the COBAS® AmpliPrep Instrument for automated sample processing and the COBAS® TaqMan® Analyser or COBAS® TaqMan® 48 Analyser for automated amplification and detection.

This test is intended for use in conjunction with clinical presentation and other laboratory markers as an aid in assessing viral response to antiviral therapy as measured by change in plasma HBV DNA levels.

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COBAS® AmpliPrep/COBAS® TaqMan® HCV Test v2.0

COBAS® AmpliPrep/COBAS® TaqMan® HCV Test v2.0

The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test v2.0 is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) in human plasma or serum using the COBAS® AmpliPrep Instrument for automated sample processing and the COBAS® TaqMan® Analyser or COBAS® TaqMan® 48 Analyser for automated amplification and detection.

This test is intended for use in conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV. The test can be used to assess the probability of a sustained viral response early in a course of antiviral therapy and to assess viral response to antiviral treatment as measured by changes in serum or plasma HCV RNA levels.

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COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test v2.0

COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test v2.0

The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 is an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma using the COBAS® AmpliPrep Instrument for automated specimen processing and COBAS® TaqMan® Analyser or COBAS® TaqMan® 48 Analyser for automated amplification and detection. The test can quantitate HIV-1 RNA over the range of 20 - 10,000,000 copies/mL. One copy of HIV-1 RNA is equivalent to 1.7 ± 0.1 International Units (IU) based on the WHO standard (NIBSC code 97/656).

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COBAS® AmpliPrep/COBAS® TaqMan® HLA-B*5701 Screening Test

COBAS® AmpliPrep/COBAS® TaqMan® HLA-B*5701 Screening Test

Confidently identify patients who have a hypersensitivity to abacavir

Use PCR technology to facilitate HLA-B*5701 screening and better manage HIV patients who could potentially have hypersensitivity reactions to abacavir.

Allergic hypersensitivity to the HIV reverse nucleoside transcriptase inhibitor, abacavir, is highly associated with a specific allele at the HLA-B locus, HLA-B*5701.*† The COBAS® AmpliPrep / COBAS® TaqMan® HLA-B*5701 Screening Test‡ uses PCR technology to facilitate HLA-B*5701 screening in the routine clinical setting for managing HIV patients.

HLA-B*5701 screening promotes more informed patient treatment and facilitates safer disease management as recommended by the US Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) and the International AIDS Society-USA Panel (IAS).

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COBAS® DNA Sample Preparation Kit

COBAS® DNA Sample Preparation Kit

A manual kit to isolate genomic DNA from FFPET specimens

The cobas® DNA Sample Preparation Kit is used for manual sample preparation to process FFPET specimens and isolate genomic DNA based on nucleic acid binding to glass fibres. Upon completion of the sample preparation, the target DNA is amplified and detected on the cobas z 480 Analyser using the amplification and detection reagents provided in the cobas® KRAS,* BRAF and EGFR* Mutation Test kits.

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COBAS® EGFR Mutation Test

COBAS® EGFR Mutation Test

Identifies mutations in exons 18, 19, 20 and 21 of the EGFR gene.

The cobas® EGFR Mutation Test offers broad mutation coverage of EGFR exons 18, 19, 20 and 21 to help select non-small cell lung cancer (NSCLC) patients for treatment with EGFR inhibitors.

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COBAS® HPV Test

COBAS® HPV Test

The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilises amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridisation for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies (types) HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant infection levels.

Specimens are limited to cervical cells collected in cobas PCR Cell Collection Media, PreservCyt Solution (Cytyc Corp.) and SurePath Preservative Fluid (BD Diagnostics-TriPath).

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COBAS® KRAS Mutation Test

COBAS® KRAS Mutation Test

Identifies mutations in codons 12, 13 and 61 of the KRAS gene.

The cobas® KRAS Mutation Test* offers broad mutation coverage of KRAS codons 12, 13 and 61 to identify colorectal cancer patients who are not likely to respond to anti-EGFR monoclonal antibody therapies.

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COBAS® PCR Female Swab Sample Kit

COBAS® PCR Female Swab Sample Kit

The cobas® PCR Urine Sample Kit (P/N 05170486190) and the cobas® PCR Female Swab Sample Kit (P/N 05170516190) are the recommended collection and transport kits for usage in combination with the cobas® 4800 CT/NG Test.

The cobas® PCR Sample Kits are designed to maintain the integrity of results. Through the effective stabilisation of collected samples, these kits enable faster sample preparation by completing the lysis of the cells within the primary sample tube. No refrigeration is required, making storage and transportation more convenient.

COBAS® PCR Urine Sample Kit

COBAS® PCR Urine Sample Kit

The cobas® PCR Urine Sample Kit (P/N 05170486190) and the cobas® PCR Female Swab Sample Kit (P/N 05170516190) are the recommended collection and transport kits for usage in combination with the cobas® 4800 CT/NG Test.

The cobas® PCR Sample Kits are designed to maintain the integrity of results. Through the effective stabilisation of collected samples, these kits enable faster sample preparation by completing the lysis of the cells within the primary sample tube. No refrigeration is required, making storage and transportation more convenient.

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COBAS® TaqMan® 48 Analyser

COBAS® TaqMan® 48 Analyser

The COBAS® TaqMan® 48 Analyser is designed for mid-sized clinical diagnostics laboratories that are seeking a solution to the complexity of molecular diagnostics testing, and require a single system for all of their real-time PCR needs. The instrument combines in vitro diagnostic and research (‘homebrew’) features in one instrument and automates the amplification, detection and quantification of DNA or RNA, creating a PCR analysis that is more sensitive than traditional PCR and highly accurate.

The COBAS® TaqMan® 48 is a closed analyser requiring no further user interaction after sample loading is completed, reducing the risk of sample contamination and optimising the workflow. Two independent thermal cyclers provide 1- to 48-sample capacity and allow up to two different assays to be run simultaneously, with an amplification/detection time of only 2 to 3 hours. Due to its small footprint the instrument is easily integrated into any laboratory design.

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COBAS® TaqMan® Analyser

COBAS® TaqMan® Analyser

The COBAS® TaqMan® Analyser is the high-capacity 96-format real-time PCR detection system allowing automated real-time amplification and detection of DNA or RNA for up to 4 simultaneous assays, with an amplification/detection time of only 2 to 3 hours. When docked to the COBAS® AmpliPrep Instrument via the Docking Station, it offers complete walk-away automation of the PCR process with overnight operation. The Docking Station transports the samples prepared by the COBAS® AmpliPrep Instrument automatically to the COBAS® TaqMan® 96 Analyser. The docked system streamlines the PCR workflow from “sample in” to “result out” without any manual intervention. COBAS® AmpliPrep Instrument and COBAS® TaqMan® 96 Analyser can also be networked for automation of all steps without the Docking Station.

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COBAS® TaqMan® CT Test v2.0

COBAS® TaqMan® CT Test v2.0

The COBAS® TaqMan® CT Test, v2.0, is an in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis DNA in female endocervical swabs specimens or male and female urine, This test utilises the AMPLICOR CT/NG Sample Preparation Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyser for automated amplification and detection. The COBAS® TaqMan® CT Test, v2.0, offers up to 48 tests per run and provides results in only 2.5 hours after sample preparation.

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