Project HALO: A Post-Market, Observational Registry of Data Derived from Serenity LiquidTM, Serenity GenomeTM, and Clinical Parameters (Preprint)

BACKGROUND Registries are a valuable tool for data collection and observation of medical innovations in a real-world setting. Serenity LiquidTM and Serenity GenomeTM are newly launched diagnostic platforms analyzing large genetic datasets in combination with clinical data to deliver precision preventative medicine. To this point, no systematic data is available to observe the use and clinical implementations of these platforms. OBJECTIVE To create a data repository collecting data from Serenity LiquidTM, Serenity GenomeTM, and clinical parameters for analyses. METHODS Individuals receiving Serenity LiquidTM or Serenity GenomeTM are solicited to participate in this registry. In addition to the initial dataset, a clinical update is secured every six months. Data from the registry participants are pseudo-anonymized and archived in a HIPPA-compliant research database for regular analyses. RESULTS Includes but is not limited to correlations between genetic and clinical data, the impact of genetic data on the clinical course of patients, comparisons between specific cohorts (within this database and against historical cohorts) on an ongoing basis. CONCLUSIONS This is a prospective registry collecting genetic and clinical data to gather important information, provide novel insights by continuously analyzing the data in this registry.