CDx DesignerCDx Designer

Companion Diagnostic Software Development Tool

Powerful data analysis software everyone can use.


CDx Designer was designed to automate the software development process for many in-vitro diagnostics tests and other general analytics software. It's a powerful tool that can create a Windows application with any custom data analysis requirements, reading in machine, or other raw measurement data, analyzing it with any custom logic requirements, and generating a report with custom fields and results. 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 enables early drug-diagnostic (Rx/CDx) co-developments, and streamlines the complete data analysis software development process. Also supports compliance with IEC 62304 - software lifecycle standard for medical devices.


Standardized Development Workflow




Benefits for Companion Diagnostics Applications

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. COx Designer was successfully used to implement many companion diagnostic applications for a variety of in vitro diagnostic assays, some using genomic sequencing, PCR (polymerase chain reaction), FISH/CISH (fluorescence/chromogenic in-situ hybridization), NGS (next generation sequencing), LAMP (loop-mediated isothermal amplification), and others.

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 data analysis application.

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.