The emergence of targeted oncology therapies has led to an increased need for companion diagnostic (CoDx) tests. Navigate BioPharma has broad experience in the development and support of CoDx and submissions for PMA and CE Marking approval. Our flexible business models allow for strategic collaboration with both pharmaceutical companies and IVD manufacturers to provide services for customized analytical and clinical validation.
Navigate BioPharma in-house experts bring a wealth of experience in diagnostic test selection and validation. Our dedicated CoDx teams cover project management, discover/research, assay development, quality assurance, regulatory, manufacturing and commercialization.
We currently have established relationships with multiple key diagnostic companies across numerous and diverse projects and have the capability to submit internal PMA programs through Navigate BioPharma. This allows flexibility in platform providers and options to meet your CoDx needs. We continue to expand our relationships and strength in this area as the demand in personalized precision medicine solutions grow.