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Your pathways. Our assays.

ApoCell provides customized biomarker assay development services to meet the unique needs of your pre-clinical and clinical trials. We further validate the assay for its sensitivity, specificity, accuracy, reproducibility, and stability. Through assay validation studies, ApoCell scientists can provide you with reliable and accurate results that are scientifically sound and meet FDA and other regulatory directives.

Signalling Pathways:

An assay validation study can help you make important decisions to protect the integrity of your trial. The three levels of service we provide to optimize and validate your assay are:

  • Proof-of-concept (POC): verify the feasibility of reagents.
  • Qualification: test the validity of biomarkers by using method-to-method comparing studies.
  • Full-validation: validate assay through standard tests to be applicable, and to support GCP and GLP studies. The validation includes intra- and inter- precision, tech-to-tech comparison, sample stability, sample recovery, linearity, instrument to instrument comparison, and cross-lab validation etc.

Assay validation study is focused on assay performance. The validated assay is to ensure that the tested biomarker is linked to a clinical significance to support your Investigative New Drug Application (INDA) and New Drug Application (NDA).