ApoCell provides customized biomarker assay development solutions to meet the unique needs of each project, from proof of concept through full fit-for-purpose validation.

We use known biological control samples with IRB approved protocols to access various types of cancer patient blood and tissue samples for validation of the developed assay before it’s used in your clinical trial.  Our experienced scientific team has developed hundreds of biomarker assays across many platforms, including:

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For more information on how we can help validate your assay to support your clinical pipeline.

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Our flexible approach ensures the right support that extends beyond assay development

We offer a diverse suite of biomarker assay development services for both tumor and liquid biopsies that can validate biomarker assays sensitivity, specificity, accuracy, reproducibility, and stability.

Through our assay validation approach, our scientists can provide reliable and accurate results that are scientifically sound and compliant from a regulatory perspective.  From concept, through assay development and validation for clinical trial implementation, the ApoCell team is there with you every step of the way.

Assay Development TierDescription
Proof of Concept (POC)Verify the feasibility of reagents.
QualificationTest the validity of biomarkers by using method-to-method comparison studies.
Full ValidationValidate assay through standard tests as applicable, and to support GCP and GLP studies. Typically includes intra- and inter-assay precision, tech-to-tech comparison, sample stability, sample recovery, linearity, instrument-to-instrument comparison, cross-lab validations, and/or any other specified evaluations.

Request for Proposal

Contact us to request a custom proposal to utilize ApoCell's service offerings and technologies to help meet your clinical and research needs.

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Clinical Trial Support

ApoCell provides biomarker design, sample collection and logistics support, and esoteric testing services across multiple therapeutic areas.

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