BIOMARKER VALIDATION

Our team can provide the samples, data and expertise needed to take your biomarker through the early stages of validation; from discovery right up to the clinical validation. This will reduce your risk and increase the value of your biomarker, ultimately getting it ready for commercialisation.

Get your biomarker ready for commercialisation

By taking advantage of our comprehensive offer you will ensure that all the steps before the final clinical validation are completed, allowing you to objectively assess the potential clinical application of your biomarker. The validation report and recommendations we provide will be just what you need to get your biomarker ready to enter into business negotiations or production steps. Your chances to secure investment will be increased, since the risk for investors will have been substantially reduced as we help you get further down the development process.

Reduce your risk and save resources

By entrusting your biomarker candidate to a team of experts you can be sure that the design and execution of your validation study will be done to the highest standards and in accordance with current regulations and legislations. Our scientific leaders have years of experience in biomarker validation and a long list of commercialized products. As an ISO 17025 accredited* organisation, all our processing and characterization methods are validated and our R&D team is experienced in validation studies. Additionally, having your biomarker validation performed by a specialized organisation will substantially reduce the timeline, allowing you to focus your time and resources on other projects.

Get well-annotated high quality samples

For your biomarker validation study you will need a whole new set of samples, different from the ones used in your training set. Through our biobank and biobank network we can provide access to a range of human biospecimens with appropriate informed consent. as well as access to our in-house pathology expertise. Our samples are collected and processed according to strict Standard Operating Procedures (SOPs) to eliminate pre-analytical bias. They are also extensively annotated with data on demographics, pre-analytics and clinical information.

Our Biomarker Validation Services

PRE-ANALYTICAL VALIDATION

    Assessment and reporting of the robustness of your biomarker to common pre-analytical variables such as sample processing delays, storage and processing temperatures and freeze-thaw cycles

ANALYTICAL VALIDATION

    Assessment and reporting of the analytical characteristics of your biomarker assay including, amongst others, precision, matrix effect, analytical range, specificity, sensitivity and stability

CLINICAL VERIFICATION

    Pilot study of limited sample size (hundreds) to verify the performance of your biomarker in clinical sample sets

METHOD COMPARISON

    Comparison of your biomarker to other relevant biomarkers and gold standards for the intended purpose

QUALITY CONTROL MATERIAL

    Production and provision of quality control materials for further validation studies and for use as quality controls in the final commercialized assays

 

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