Guardant Health presents data on blood-based tumor detection assays
Guardant Health reported new data demonstrating the high sensitivity and specificity of the blood-based Guardant360 and GuardantOMNI assays, developed by Guardant, for reporting biomarkers relevant to immunotherapy treatment selection and drug development. The data will be presented at the European Society of Medical Oncology Annual Meeting. The data come from internal validation studies for reporting tumor mutational burden with GuardantOMNI and microsatellite instability with Guardant360. Guardant Health researchers demonstrated 95% analytical sensitivity for MSI-High status at variant levels below 0.4%, and a lower limit of detection of 0.1% using Guardant360. Furthermore, clinical accuracy data for MSI-High status for samples above the limit of detection was presented from 277 advanced cancer patients samples with known MSI status using tumor tissue. The clinical data demonstrated 98.9% specificity and 92.3% sensitivity relative to standard tissue IHC, PCR or NGS-based MSI.