Development

Development

Turning a discovered biomarker into a test for clinical delivery is a complex process. Almac have significant experience in this area and offer a range of solutions to support your biomarker development. We offer these solutions both as a follow on service from our biomarker discovery or independently, taking biomarkers discovered by our clients and developing these into full clinical tests.

Our services include:

  • Determining the optimal platform for delivery of the assay
  • Platform migration
  • Tissue migrations studies
  • Assay transfer and appropriate analytical or method validation for clinical delivery
  • Proprietary panel of qPCR reference genes
  • Developing the assay instructions for use (IFU) and generating appropriate reference samples for use in validation studies or clinical delivery
  • Verified and tested software to automate the production of test report from raw test data (including algorithm analysis and QC)
  • Test interface and report
  • Analytical validation of the assay to CLIA standards establishing assay threshold, analytical precision, reference range, accuracy, as well as analytical specificity and sensitivity as required

 For further information please click here to contact us.

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