US-based laboratory Navigate BioPharma Services has announced a strategic collaboration with medical technology company BD (Becton, Dickinson and Company) to develop and commercialise flow cytometry-based companion diagnostics and tools for clinical decisions.
Navigate BioPharma is a specialty laboratory offering high-quality, innovative precision medicine solutions and bioanalytics for clinical development and diagnostic applications.
The collaboration aims to leverage the complementary expertise and capabilities of both companies to provide end-to-end solutions for pharmaceutical and biotechnology companies developing novel therapies that require companion diagnostics, tests intended to match patients with life-changing treatments, and critical clinical trial applications that utilise flow cytometry. Importantly, this collaboration aims to address a critical gap in the clinical trial field for an integrated solution provider from method development to commercialisation.
"Flow cytometry-based companion diagnostics can help identify patients who are most likely to benefit from a specific therapy, monitor their response to treatment, and optimise dosing and safety from a patient sample," said Dr Shabnam Tangri, Chief Scientific Officer at Navigate BioPharma. "Advances in flow cytometry technology made by BD can enable in vitro diagnostics (IVD) testing to be executed with accuracy, automation and standardisation across all elements of the workflow."
Vipin Bhambhani, VP of Clinical Flow Solutions, BD Biosciences added: "Flow cytometry is a powerful technique that can enable high-sensitivity, affordable testing with fast turnaround time. The collaboration will combine Navigate BioPharma's extensive experience in designing and validating biomarker assays for clinical trials and regulatory submissions with the broad BD portfolio of flow cytometry instruments, reagents, software, and IVD development services, to potentially accelerate the delivery of innovative personalised therapies to patients who need them most."
The parties intend to collaborate with biopharma organisations in the following areas:
- Accelerating the delivery of personalised therapies to patients by using biomarker-based assays as an essential clinical trial or companion diagnostic tool for cancer and other diseases.
- Addressing the latest health authority expectations for high-sensitivity minimal residual disease (MRD) monitoring assays as surrogate endpoints.
- Providing flexible and integrated solutions that can help collaborators achieve their clinical and regulatory goals by leveraging the capabilities of flow cytometry.
- Expanding the range of therapeutic options and biomarkers that can be analysed, including complex target and drug combinations, rare cell populations, cell signalling and function.
- Increasing the effectiveness of biomarker profiling and enhancing the quality and efficiency of the companion diagnostic development process by utilising the cutting-edge technologies and services offered by both companies, and Navigate BioPharma's expertise in developing specialty high-complexity and high-dimension flow cytometry and execution through regulated clinical trial testing.
Navigate BioPharma Services is an independent subsidiary in the Novartis group of companies, providing innovative biomarker and specialty bioanalytic solutions for clinical development and companion diagnostic applications. Over the past decade, Navigate BioPharma has built and developed an exclusive library of assays, methodologies, and biomarker solutions.