Clinical Validation of a Patient-specific Pharmacogenomics Assay for Enhanced Treatment Response in Bipolar Disorder-1 (BPD-1) Patients

JI Program: Exploratory

This discovery proposal is to refine and prepare a detailed plan for a pilot clinical validation study at PKUHSC of a new pharmacogenomic/metabolomic diagnostic assay system for Bipolar Disorder-1 (BPD-1) medication selection. This project is a collaborative effort between a U-M pharmacogenomics innovator (Athey lab) and one of China’s leading psychiatric research units (Lu Laboratory). Specific plans include investigating 1) How the UM-provided PhGx test will be further refined using the Michigan Genomics Initiative (MGI) data and biospecimens for delivery to PKUHSC; 2) How a detailed SMART clinical trial will be designed by the PUHSC expert team in collaboration with the U-M team; and 3) How the U-M PhGx testing platform will be extended to analyze the relevant Han Chinese Pharmacokinetic (PK) and Pharmacodynamic (PD) genetic biomarkers and plan to test out two components of U-M PhGx test in China.