Navigate BioPharma Services, a subsidiary of Novartis, and Becton Dickinson have announced a strategic partnership to jointly develop and commercialize companion diagnostics (CDx) and clinical decision solutions utilizing flow cytometry technology.
Companion diagnostics enabled by flow cytometry can help identify patients most likely to benefit from specific therapies, monitor patient responses to treatment, and optimize drug safety.
Both companies aim to collaborate with biopharmaceutical firms to leverage biomarkers for clinical trials or CDx tools. They will also explore the development of highly sensitive methods for monitoring minimal residual disease (MRD) and offer flexible and integrated solutions using flow cytometry’s technological capabilities to help partners meet their clinical and certification requirements. Additionally, they plan to expand the range of treatable options and biomarkers that can be analyzed, including complex targets and drug combinations, rare cell populations, and cell signal transduction and function.
Typically, the journey from product development to clinical trials and commercialization requires specialized expertise. The purpose of this collaboration is to address the needs of each transition step through the expertise and business capabilities of both partners.
Founded in 2017, Navigate BioPharma is a professional laboratory and CRO company that provides precision medicine solutions and bioanalytics. They focus on designing innovative biomarker solutions and customized validations for anticipated applications in clinical development, from exploration to regulation. Becton Dickinson is a global leader in flow cytometry, with strong capabilities in the field, constantly introducing new flow cytometry instruments. This collaboration leverages their respective strengths in technology to serve the advancement of precision medicine, indicating their optimism about the field of companion diagnostics.
Companion diagnostics have recently received encouragement due to a new FDA policy. In June of this year, the FDA released a policy called the “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” which encourages pharmaceutical companies to develop companion diagnostic products alongside drug development. Mature companies that have already developed multiple companion diagnostic products, such as Foundation Medicine, Qiagen, Myriad Genetic, Roche Molecular Systems, and others, will have more opportunities to develop companion diagnostic products in the form of Laboratory Developed Tests (LDTs) in the future. This will likely attract more companies looking to get involved in this field.
