Mdxhealth is a front runner in epigenetic research with a proven track record of identifying, developing, validating and delivering molecular diagnostic assays. They provide functional genomic data that can be used for personalised cancer risk assessment, with specific focus on prostate cancer.
Project 1 overview: Molecular diagnostic assay modeling
BioLizard assisted with development and optimisation of a robust model to calculate patient risk score for prostate cancer based on clinical biomarkers and other clinical features.
Project 2 overview: Molecular diagnostic triplex assay QC optimisation
The goal was to optimize the client's current qualification of reagents and equipment. Instead of a head-to-head approach, we developed a QC panel that can be used in each run to see if they fall in between the expected QC ranges.
Our approach
Molecular diagnostic assay model
- Model building to optimize clinical assay and patient risk score predictions based on a clinical biomarker panel
- Leverage advanced analytics to develop robust and personalized patient risk scoring algorithms
- Write SOPs
- Calculate performance on clinical cohorts
Molecular diagnostic triplex assay QC optimisation
- Based on historical data, develop expected range to be used as QC range
- Develop criteria for releasing new items (new reagent batch and/or equipment)
- For day-to-day QC: Analyze calibrator values, generate expected range + compare different setups
Results
- Provided detailed SOPs
- Created a robust patient risk scoring model
- Identified a potential breakthrough biomarker
- Provided detailed model documentation for NY State Dept. of Health Review
- Day–to-day QC with robust ranges for better reproducibility and quality with less time, waste, and reagents
- Improved research efficiency & capture of largest market share
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Work was performed in collaboration with Mdxhealth.
