BioMosaics

Biomarker Development Services

We provide start-to-finish biomarker assay development and testing services designed to support the unique needs of your clinical therapeutics programs. These services typically include developing, validating and performing assays for a diverse array of analytes in complex biological matrices. In addition to assay development, we can provide a complete set of SOPs and/or manufacturing documents, or we can manufacture assay kits for your use or distribution. We also provide OEM reagent components (diluents, standards, controls, calibrators, etc.) for customers developing their own assays; these reagents can be filled, sealed, and labeled according to your needs. Development services provided include:

Clinic-ready biomarker assay platforms; Immunoassay (ELISA, EIA), Immunohistochemistry, Flow Cytometry, cell-based assays;
Pharmacogenomic and molecular biology testing: genotyping, qPCR, RT-PCR;

Technical collaboration and assay optimization in a GLP-compliant environment

For most promising candidate biomarkers, a thorough evaluation of the clinical need, utility and market readiness is needed to justify development. Our development team has over 40 years of experience in diagnostic assay development and clinical testing for pharmaceutical companies. We can perform initial biomarker placement evaluations and advise you on the best path for success. We have expert scientists to personally oversee your project and perform assay validations as needed. Our client service and project management functions are critical elements to keeping your project on track and your clinical program moving forward. Clinical advisory services include:

Clinical protocol development for biomarker endpoints; clinical trial testing service
Commercial evaluation; Technology transfer requirements, medical need evaluation, companion diagnostic opportunities
Regulatory approval strategy; FDA/IVD and CE Mark

We foster a collaborative work arrangement. For many biomarker projects, creative financing opportunities exist, including Small Business Innovative Research (SBIR) grant applications, external funding sources and commercialization growth opportunities.

Contact us now to discuss your biomarker development needs. Contact Us