Introduction
Prenosis is a Chicago-based artificial intelligence company founded in 2014 that enables precision medicine in acute care through biomarker-clinical datasets and regulatory-grade diagnostics. Bobby Reddy Jr, PhD, co-founded Prenosis and serves as Chief Executive Officer — confirmed on the company’s team page and in its April 3, 2024 news release announcing FDA De Novo marketing authorization for Sepsis ImmunoScore, the first AI-powered sepsis diagnostic cleared through that pathway.
Prenosis built the Immunix precision medicine platform on what it describes as a large, rapidly growing biomarker-clinical dataset for rapid immune response — using that foundation to develop diagnostics that integrate into electronic medical record workflows rather than operating as standalone alert systems.
What the company does
Prenosis develops AI software-as-a-medical-device products that analyze diverse acute-care parameters — up to 22 holistic inputs including vitals, laboratory biomarkers such as procalcitonin, and clinical context — to assess sepsis risk and predict adverse outcomes within 24 hours of patient assessment. Sepsis ImmunoScore generates a risk score and categorical risk assignment with an intuitive display explaining how each parameter increased or decreased sepsis risk for an individual patient.
Human factors testing cited in Prenosis materials reported that clinicians agreed the graphical interface demystified AI and built trust — a design choice Reddy emphasized when describing Prenosis’s partnership-oriented approach to clinician-AI collaboration rather than black-box scoring alone.
Following FDA authorization, Prenosis announced a commercial distribution collaboration with Roche making Sepsis ImmunoScore available on the navify Algorithm Suite — integrating lab-based biomarkers, clinical data, and AI for health-system customers seeking certified algorithm platforms.
Who it serves
Prenosis serves hospital emergency departments, intensive care units, and health systems combatting sepsis — a leading cause of in-hospital mortality where delayed recognition drives poor outcomes. Laboratory and health IT partners distribute Sepsis ImmunoScore through Roche’s platform, extending reach beyond direct hospital sales. Payers and quality leaders encounter Prenosis through metrics tied to early sepsis recognition, treatment timing, and coding frameworks Prenosis referenced in ImmunoScore resource materials including ICD-10-PCS coding guidance.
Company background
Reddy co-founded Prenosis in 2014 to decode atypical human immune responses in fast-moving acute environments where traditional single-biomarker approaches underperform. The company spent approximately eighteen months working with FDA to demonstrate safety and efficacy before De Novo authorization — a timeline Reddy referenced when explaining Prenosis’s deliberate regulatory path rather than premature commercialization. Prenosis maintains a management team spanning clinical research operations, engineering, and clinical advisors including sepsis specialists listed on its team page.
Chicago headquarters situates Prenosis among Midwest health-tech and academic medical center partnerships common to acute-care AI startups seeking diverse training cohorts.
Product and AI capabilities
Prenosis’s AI applies machine learning across combined biomarker and clinical feature sets trained on thousands of patients in its proprietary dataset — distinguishing ImmunoScore from rule-based sepsis alerts that fire on isolated threshold breaches. The diagnostic integrates into EMR workflow as a decision support tool complementary to, not competitive with, existing alert systems per Prenosis product positioning.
Post-authorization studies planned to demonstrate accuracy and clinical decision-making impact remain important validation steps for hospital buyers beyond regulatory clearance alone.
Key developments
2014: Prenosis founded in Chicago. April 3, 2024: FDA De Novo authorization for Sepsis ImmunoScore (official news release). April 10, 2024: Roche commercial distribution collaboration announced. Bobby Reddy Jr named TIME100 Health 2025 honoree per separate Prenosis news post — cited for leadership context, not as official milestone source.
Why it matters
Prenosis matters because sepsis diagnostics have resisted scalable AI solutions for decades — FDA De Novo authorization establishes a regulatory precedent other acute-care AI vendors will study closely. Transparent parameter-level explanations address clinician trust barriers that sank many prior sepsis prediction deployments. Prenosis sits in Brel digital health coverage near clinical AI infrastructure companies but distinguishes itself through authorized diagnostic status rather than documentation or triage alone.
Hospital CMIOs evaluating ImmunoScore should confirm EMR integration path — Roche navify distribution versus direct deployment — and local sepsis bundle compliance requirements.
Sector context
Prenosis belongs in Brel’s AI in healthcare coverage under digital health and AI diagnostics, distinct from remote monitoring vendors such as Biofourmis. Readers should separate FDA authorization from payer coverage and guideline inclusion — three distinct adoption gates for hospital procurement.
Sources and references
Prenosis FDA De Novo authorization release (April 3, 2024) and team leadership page.
- Prenosis — Sepsis ImmunoScore FDA De Novo (prenosis.com, April 3, 2024)
- Prenosis — Team / leadership (prenosis.com)
Reviewed July 10, 2026. Bobby Reddy Jr is Co-Founder and CEO. Iman Hajirasouliha CSV error corrected.