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Work was done in collaboration with MDxHealth.
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About the client
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
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
Optimise current qualification of reagents/equipment. Instead of head-to-head
approach, develop a QC panel that can be used in each run to see if they fall in
between the expected QC ranges.
“We were very pleased with the work BioLizard did. The BioLizard team were very flexible and took the necessary time to fully understand our needs. Their tailored service allowed us to draw meaningful conclusions from our data.” – MDxHealth
Our approach
- Molecular diagnostic assay model
• Model building to optimize clinical assay and patient risk score predictions.
• 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.
Day–to-day QC with robust ranges for better reproducibility. Quality with less time, waste, and reagents.