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Biomarker development

Contract R&D Services and Support

Whether your needs are contract biomarker research, support or development, we provide the tools you need to accomplish your project. We offer: Biomarker validation and companion diagnostic development; custom IHC antibody development, custom IHC Kit development, validation, regulatory compliance support, package and delivery development. GLP performance of oncology biomarker analysis for basic research. Performing your biomarker studies under GLP compliance in our laboratory will ensure data integrity. We provide biomarker testing services for clinical trials. Studies can be set up under GLP conditions, including systems for data integration into existing CRFs. In addition, our experience in working with CRO's and data management specialists will streamline your side of the process, providing your clinicians with reliable data. We perform biomarker assays of somatic mutation (HPRT cloning assay, PI Glycan-A cloning assay, PI Glycan-A Flow Cytometry assay) for a variety of biotech/pharma applications.

We provide start-to-finish biomarker assay development and testing services designed to support the unique needs of your clinical development 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. Available development services include: Clinic-ready biomarker assay platforms - Immunoassay (ELISA, EIA), Immunohistochemistry, Immunocytochemistry, 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.

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