Experienced Biomarker and Assay Validation Experts
MD Biosciences has a rich history in the field of diagnostics, with over 25 years experience developing, validating and manufacturing diagnostic assays.
Our services provide support to clients at every stage of the development pipeline, from initial target identification and validation of clinical relevance through to GMP manufacturing of kits/reagents and implementation within our expansive global distribution network.
Our approach allows for multiple routes of implementation and commercialization for diagnostic products, including Research Use Only assays, Investigational Use Only assays, Laboratory Developed Tests, full-fledged In Vitro Diagnostic kits and Companion Diagnostic devices for targeted therapies.
Whether our clients require novel fit-for-purpose assays for exploratory studies or regulated products for Class III diagnostic evaluations in clinical trials, our proficient laboratory scientists, biomarker experts and regulatory consultants can determine the best course of action to accelerate diagnostic programs to the next phase of the pipeline. Contact our clinical team today to discuss you projects!
Clinical Diagnostic Services