The scope of our genomics and proteomics platforms for IVD and CDx tests is unparalleled. Moreover, our global installed base gives you access to clinical laboratories and key experts worldwide.


Genomic Analysis

 

Ion PGM™ Dx System – develop diagnostic assays with next-generation sequencing

Applied Biosystems® 7500 Fast Dx Real-Time PCR System – view quality diagnostic results in under 40 minutes

Applied Biosystems® QuantStudio™ Dx Real-Time PCR System  – develop accurate and sensitive molecular diagnostic tests

Applied Biosystems® 3500 Dx Series Genetic Analyzer – sequencing and analysis in process-controlled environments


Ion PGM™ Dx System – in vitro diagnostics in regulated laboratory environments

 

Designed to serve the broad clinical molecular diagnostics community, Ion PGM™ Dx System combines the speed and simplicity of the Ion Torrent™ platform with key workflow advantages designed specifically for in vitro diagnostic applications in regulated laboratory environments. 

 

Ion PGM™ Dx System offers a complete next-generation sequencing (NGS) system of instruments, reagents and software, all developed in accordance with ISO 13485 requirements. It is also developed under design control and thus has a complete design history file. Validation using germline variants with library kits based on proven Ion AmpliSeq™ technology enables accurate and reliable genetic analysis from more clinical samples, even with a limited amount of DNA. In-run control for automatic assessment of run success is also included. User-created protocols are run in a locked workflow environment.

 

By offering role-based workflows, sample and reagent tracking, QC metrics and audit trail, Ion PGM™ Dx System helps enable 21CFR part 11 compliance. Furthermore, it is compatible with many LIMS, providing XML input and manager-controlled data output.

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Fig: Ion PGM™ Dx System  

  • Get accurate, highly reproducible genetic variant analyses with as little as 10 ng input DNA.
  • Experience a sample-to-analysis time of less than two days.
  • Use the Integrated software to track sample and reagent including auditing and traceability compliance. 
  • Average SNV sensitivity exceeds 99.5%.

Applied Biosystems® 7500 Fast Dx Real-Time PCR – view quality diagnostic results in under 40 minutes


Together with its SDS Software, this real-time nucleic acid amplification and five-color fluorescence detection instrument delivers high-quality in-vitro diagnostic results. Its convenient 96-well format eases plate setup if automation is not available. Tube strips can also be accommodated.

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Fig: Applied Biosystems® QuantStudio™ Dx Real-Time PCR System

  • Get Fast-mode runs that take less than forty minutes while the optional standard mode facilitates standard-length real-time PCR assays without changing thermal cycling parameters.
  • Experience flexibility with the intuitive software to develop assays and also run pre-optimized protocols in a secure environment.
  • Easy start up with our instrument service and support which includes Installation Qualification, Operation Qualification and Performance Qualification, spectral calibration and software setup.

Applied Biosystems® QuantStudio™ Dx Real-Time PCR System


Applied Biosystems® QuantStudio™ Dx Real-Time PCR System has the performance, flexibility, expandability and support needed to meet the evolving needs of clinical diagnostic laboratories today and tomorrow. In addition to a 96-Well Fast Block format, it accepts 96-well standard, 384-well and array card formats that can be used for laboratory-developed tests and future IVD assays.

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Fig: Applied Biosystems® QuantStudio™ Dx Real-Time PCR System

  • Get efficient workflows and assays speed processing with proven performance, security and reliability.
  • Combine with the Quidel® Molecular Assays and quickly deliver results you can trust.
  • Use the available test development mode, and Applied Biosystems® QuantStudio™ Dx Software tracks reagent and patient information and assists with security, auditing and electronic record signatures.

 

 


Applied Biosystems® 3500 Dx Series Genetic Analyzer – sequencing and analysis in process-controlled environments

 

Designed for simple setup, operation and maintenance, this easy-to-run, easy-to-own DNA sequencer is based on an IVD-labeled capillary electrophoresis solution that integrates key platform improvements, including superior optical and thermal subsystem reliability and control.

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Fig: Applied Biosystems® 3500 Dx Series Genetic Analyzer

  • Deliver answers quickly, easily and confidently, helping trained operators search for genetic changes that may indicate disease presence or susceptibility.
  • Comply with Directive 98/79/EC on In Vitro Diagnostic Medical Devices, important when developing and validating nucleic acid-based assays.
  • Use the consumables, reagents and accessories which are created especially for the clinical laboratory and comply with relevant ISO standards.
  • Confidence comes with the data collection and primary analysis software that is IVD-labeled.

Some of these products are not FDA cleared. Please contact your sales representative for more information. Product claims may differ from country to country based on regulations and product approvals. Please contact your country representative for further details.