CDx DesignerCDx Designer

Companion Diagnostic Software Development Tool

Powerful data analysis software Creator.


CDx Designer was designed to automate the software development process for in-vitro diagnostics tests and other data analysis or conversion software. It's a powerful tool that can create a Windows application with any custom data analysis requirements, reading in raw data, analyzing it with custom logic or algorithm, and generating a custom report output. The CDx Designer platform provides an intuitive graphical interface with a variety of data visualization tools and many standard examples to begin with. Additional interfaces to LIS and LIMS are supported and flexible user interface options to integrate with any lab, or other perational requirements.

A Companion Diagnostic (CDx) device can be In Vitro Diagnostic (IVD) device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product.

CDx Designer is architected to enable early drug-diagnostic (Rx/CDx) co-developments, and to streamline the complete data analysis software development process. All with full compliance to IEC 62304 - software lifecycle standard for medical devices.


Standardized Development Workflow




Benefits for Typical Companion Diagnostics Applications and SAMD - Software As a Medical Device

Save time developing the software early with your technical team, with little to no extra cost for hiring a software development company, or a contractor to write the custom software application. CDx Designer is a perfect solution to implement compliant in-vitro diagnostic devices, decision support tools or other data integration for genomic sequencing, PCR (polymerase chain reaction), FISH/CISH (fluorescence/chromogenic in-situ hybridization), NGS (next generation sequencing), LAMP (loop-mediated isothermal amplification), and other technologies.

cdx device workflow

Avoid development error risks and exaggerated costs resulting from hiring the software development resources later till clinical testing confirms positive results and warrants implementation. With CDx Designer the software development process is iterative, and the platform is completely graphical with intuitive tools to define the input data, the processing requirements and the report and output to generate with the results.

Every software application created includes built in safety measures to ensure correct operation and results. Some examples include:

  • Input file validation
  • Built-in integrity and validation checks
  • Controlled computing environment
  • Supports IVD/safety labeling
  • QC logging for performance monitoring
  • Secure data with encryption


Graphical Development Environment Screenshots


Comprehensive data visualization with a wizard-like workflow and guidance.


Flexible input and output file handling options, for Excel, Word, PDF, JPEG, etc.


Advanced computational engine that can handle any data analysis requirements.


Extensible scripting environment supporting Javascript, R, PHP, Python, and others.


Customizable Reports with any data and graphical content, formatting, etc., PDF, JPEG, Word, Excel, Text

cdx device

Generated data analysis application with locked-down configuration.

This instructional shows how to create a simple application step by step.

Get started with CDx DesignerCDx Designer




Iterative development of CDx (assay).
From input data, custom logic and proprietary data analysis...
to output reports and secure data


Contact us to discuss your custom software development requirements.