PCR Data Analysis & Reporting

MEDICAL SYSTEM:

Companion Diagnostic Integrated Development Environment

WORK SCOPE:

Develop an integrated development environment for developing Companion Diagnostics applications, using a common workflow that guides the user through performance and functional synthesis, with built-in consistency checks and safety checks. The IDE is intended to be used for experimental CDx development projects offering features for high collaborations and configuration management (version control).

BACKGROUND:

Based on previous architecture assessment which defined all key stakeholders' needs and an appropriate architecture, a Windows graphical application was developed using WPF, C# and .NET technologies and reputable 3rd party software packages. The resulting solution needs to be extensible to support modifications and feature additions, including internationalization with language packs.

RESULTS:

The developed CDx IDE provided an intuitive workflow for the user to model the exact specifications for input, data analysis, and outputs of the target CDx executable. Each CDx project is based on a model file composed of the following (meta-data) elements:

  • Input data sources and data within (XLS, CSV file formats)
  • Input data validation (logical rules for risk control)
  • Data analysis logic, and interfaces to input/output data (representation of the assay specifications)
  • Output report format, content, and security aspects

Using the CDx IDE tool, the development team can efficiently collaborate on the CDx project contributing to different parts of the model concurrently with automatic integration and effective configuration management. The output reports created can be in Word, PDF, Excel, text, or image (JPEG, GIF, PNG) formats; offering easy integration for system users with flexible deployment requirements. Further, the password protection capability provides adequate data security to protect confidential information and conform with HIPAA regulations.

Once the preliminary testing is completed by the team, with a single click of a button the CDx IDE tool creates a stand-alone CDx executable with the complete specifications defined including unique identification (revision) information for traceability; with that, formal verification and validation of the CDx medical device accessory can begin following the conventional regulatory design controls requirements.

For added safety measures against vulnerabilities in the PC environment under control of the partner/external commercial organization, every CDx application generated by the IDE includes built-in safety checks, including:

  • Verifying the user computer specifications conforms to the validated computer requirements as described in the IFU (e.g. Windows version, .NET framework, etc.)
  • Performing an exhaustive functional test that generates a report corresponding to a controlled data set, and verifying the output matches the expected results
  • Additional risk control measures mitigating user errors:
    • Input data source validations (unique identification), with consistency checks
    • An exhaustive rule set checking the integrity and completeness of the data analysis logic (e.g. all input and output parameters are read or written, and all expected report fields are written
    • Safe-guards for mathematical and loop errors (e.g. overflow, arithmetic type mismatches, floating precision errors, upper/lower bounds).

As a final step, the CDx IDE was evaluated by replicating a previously developed CDx application and verifying exact functional equivalence. The development time of the CDx executable itself was at least 4 times faster, and in general it offered better usability characteristics. Other benefits include better process quality control, higher resolution traceability (build date/time, report date/time, etc.), more efficient team collaborations, and significant cost-savings in the overall CDx lifecycle.

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