Study Rationale: Managing and treating Parkinson’s is extremely challenging without the right tools and insights. According to the Michael J. Fox Foundation, “the need for objective Parkinson’s disease tests, or biomarkers…has become more urgent as more projects enter human testing. Objective disease tests would speed drug development by identifying people most likely to respond to treatment, tracking disease progression and assessing therapeutic impact.” Octave has proven its precision- care platform in multiple sclerosis, including a multiplexed custom biomarker assay panel, now used in ~40 clinics in the US. Our approach, technology, and learnings will inform how we develop a precision care solution for Parkinson’s, which begins with biomarker panel development.
Hypothesis: Our goal is to develop a multiplexed custom assay panel specific to Parkinson’s that comprehensively represents the complexity and heterogeneity of the disease. By using tailored algorithms, the panel is intended to support several clinical applications ranging from earlier diagnosis, improved care with a deeper understanding on the impact of drugs on biology, and measure disease progression.
Study Design: Octave has developed a multiplexed custom assay panel for multiple sclerosis called the MSDA (MS Disease Activity) test. We will lead a similar project to create a custom assay panel for Parkinson’s from Feasibility and Discovery through Development and Validation. This process will consist of casting the net widely in a series of studies with deeply-phenotyped biospecimens, and iteratively identifying the most relevant proteins for PD assessments through correlation of biomarker signatures to relevant endpoints and employ a systems biology approach to corroborate pathophysiology.
Impact on Diagnosis/Treatment of Parkinson’s disease: Fluid biomarkers enable deeper insight into underlying pathophysiology for diagnosis, prognosis, and disease modifying treatment monitoring. We expect this panel to be used for a variety of clinical applications ranging from earlier diagnosis, evaluation of drug therapies on biology, and identification of disease progression, all which will inform a deeper understanding of the patient journey, relevant phenotypes and disease stages, enabling clinicians to better care for Parkinson’s patients.
Next Steps for Development: If successful, after Analytical and Clinical Validation, we will move into pilot launch with a selected clinic prior to scaling to a commercial launch. We understand that a continuum of studies will be necessary to build the body of evidence that expands claims and reinforces clinical utility.