Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum

The AXIS Network is a prospective, multicenter observational registry designed to generate real-world evidence on the use of metagenomic sequencing in clinical practice across a broad range of patient populations, infectious disease syndromes, and clinical care settings. Participants receiving routine clinical care at participating institutions may be enrolled into cohort-specific registries that evaluate how metagenomic sequencing is used for diagnostic evaluation, surveillance of high-risk populations, or longitudinal monitoring of treatment response. The study does not assign participants to any intervention, alter standard clinical care, or require study-mandated testing or treatment. Instead, it collects clinical information generated during routine care, including diagnostic testing, antimicrobial use, clinical management decisions, healthcare utilization, and clinical outcomes. The primary objective of AXIS is to evaluate how metagenomic sequencing informs clinical decision-making and is associated with downstream management and clinical outcomes. Secondary objectives include characterization of test utilization patterns, diagnostic integration, antimicrobial management decisions, healthcare utilization, and longitudinal monitoring strategies. Data collected through AXIS may also support development of predictive models and clinical decision-support tools.

Inclusion Criteria: * Participant receives care at a participating AXIS site. * Participant meets eligibility criteria for at least one active AXIS cohort as defined in the applicable cohort appendix. * Participant or legally authorized representative is able to provide informed consent, unless waived by the reviewing IRB. Exclusion Criteria: * Any condition that, in the opinion of the investigator, would make participation inappropriate or prevent completion of required study procedures. * Additional cohort-specific exclusion criteria may apply and are defined within the applicable cohort appendix.