Transforming sepsis care with AI: Prenosis delivers innovation

The following i the latest in our "Brief interviews with healthcare innovators" series highlighting innovative companies in the Labcorp Venture Fund portfolio. The mission of the Labcorp Venture Fund is to strategically invest in cutting-edge businesses that make healthcare more personalized, accessible and convenient to improve health and improve lives.

These innovators are using technology to satisfy their mission of improving health system operations and patient experiences while simplifying and reducing the growing duties of physicians, healthcare staff and administrators alike. This month, Jim Almas, MD, vice president and national medical director for clinical effectiveness, spoke with Bobby Reddy Jr., PhD, co-founder and CEO of Prenosis, a trailblazing startup that uses AI to redefine the standard of care for critical conditions. 

Prenosis was founded in 2014. Their mission is to improve patient lives by tailoring healthcare to each person's biology through augmenting clinical decision-making with individualized, integrated diagnostics and treatment.

Origination of Innovation

Jim Almas: Can you tell us the origin story for Prenosis?

Bobby Reddy Jr: After witnessing challenges in my father's healthcare experience, I began to see common concerns and felt a need to improve the system. Patients wanted tailored care where providers understand their unique needs, but the U.S. healthcare system seemed to be more focused on protocols than people. 

The experience also made me wonder why so many other aspects of our lives are personalized, but not healthcare.

Jim Almas: Wow. It’s clear this isn’t just business for you, it’s deeply personal. How did your father’s experience guide your mission?

Bobby Reddy Jr: Through my work developing early screening technologies for diseases and extensive experience with clinical personnel, I recognized an opportunity to bring new tools and precision medicine used in oncology to acute and critical care settings where long-term quality of life decisions are made. 

Additionally, the devastating impact of sepsis, which contributes to one in three hospital deaths in the U.S., presented an urgent need for innovation. Providers have lacked meaningful tools they could use every day to understand the complexity and heterogeneity of conditions—and therefore drive targeted sepsis treatment.

New technology in healthcare

Jim Almas: What technology does Prenosis use and how does it work?

Bobby Reddy Jr: We used AI, machine learning and proprietary biomarker assays to develop our solutions. In fact, Sepsis ImmunoScore™ is the first-ever FDA-authorized AI diagnostic tool for sepsis. 

It tackles the challenge of accurately diagnosing and predicting future sepsis risk by evaluating a patient's biological status and providing a risk score within 24 hours. Sepsis ImmunoScore has the potential to significantly improve patient care by enabling earlier and more accurate diagnosis of sepsis. It assists providers in identifying patients at highest risk for sepsis or progression to sepsis within 24 hours. Unlike alternatives, Sepsis ImmunoScore takes a comprehensive biological approach similar to precision oncology. 

Jim Almas: That's amazing. Can you describe how it works?

Bobby Reddy Jr: Our solution holistically evaluates a patient's biological status to produce a risk score that stratifies patients into one of four discrete risk categories. The tool also integrates directly into a hospital's EMR system so it’s embedded in clinical workflows. 

Sepsis ImmunoScore features an intuitive display, which reveals how each individual patient's parameters were used to calculate their score. This transparency is critical in building trust with providers and enabling a true clinician-AI partnership.

Jim Almas: What makes your solution unique?

Bobby Reddy Jr: I believe we deliver a unique approach due to five key factors:

1. Sepsis ImmunoScore is the first-ever FDA-authorized AI diagnostic tool for sepsis.
2. We take a comprehensive, biological approach to the study of infection response, similar to the precision medicine approach in cancer with sequencing of tumors. 
3. We use AI and machine learning to study the biological response to infection to get a deeper understanding of how to treat the hyperinflammatory response.
4. Our evidence generation platform, Immunix™, was used to develop Sepsis ImmunoScore and has the potential to create more diagnostic tools and precision therapeutics guided by AI.
5. The combination of diagnostic and predictive information has never been available in a legally marketed device for sepsis, potentially leading to earlier interventions and improved patient outcomes.

Jim Almas: That sounds impressive, but how do you ensure accuracy?

Bobby Reddy Jr: Sepsis ImmunoScore involved rigorous clinical validation against physician-confirmed sepsis cases and real-world testing across hospital instruments.

To develop reliability and accuracy, we spent over a decade in collaboration with 12 partner hospitals. We check validation in four significant ways:

1. Rigorous clinical validation: We tested our device against physician-confirmed sepsis cases, using expert panels to verify diagnoses within 24 hours of clinical suspicion.
2. Input data requirements: Our system evaluates whether it has sufficient quality data before generating results. When important measurements are missing, the device prompts the order of those measurements.
3. Real-world testing: We understand different hospital measurements have differing biases in measuring analytes. We simulated how measurement bias and variance affect the Sepsis ImmunoScore results, assuring adequate performance across FDA-approved instruments.
4. Continuous monitoring: We actively track measurement patterns over time, verify proper integration with each hospital's EMR system and assess ongoing diagnostic performance to maintain accuracy.

We've built a proprietary biobank of over 120,000 blood samples representing over 30,000 patients to deeply study the immune response to infection using AI and machine learning. We also use in-house assays in our lab to generate critical biological data from these blood samples. 

How technological innovation enhanced patient care, efficiency and cost savings

Jim Almas: How has your solution improved patient care or operational efficiency?

Boddy Reddy Jr: Sepsis ImmunoScore: 

• Assists in identifying high-risk patients
• Enables earlier, more accurate sepsis diagnosis 
• Improves care and survivals rates while reducing length of stay
• Integrates with EMRs to enhance operational efficiency for providers
• Helps decrease healthcare costs for patients, health plans and hospitals

Jim Almas: Do you have any success stories demonstrating your solution's impact?

Boddy Reddy Jr: Sepsis ImmunoScore was recognized as one of TIME's Best Inventions of 2024. Early data from an in-progress BARDA-funded utility study also shows increased sepsis identification over standard clinical practices.

Jim Almas: What metrics do you use to measure success?

Boddy Reddy Jr: We use measures such as:

• Survival rates
• Length of stay
• Sepsis-related costs
• Time to diagnosis/intervention
• Compliance with treatment bundles

The future of innovation in healthcare

Jim Almas: What are your plans for future innovations?

Boddy Reddy Jr: We plan on continuing to leverage our biobank and evidence platform to develop more integrated diagnostic and therapeutic solutions for acute care conditions beyond sepsis. We also aim to apply our methodologies to areas like heart failure and novel therapeutics guided by AI. 

Jim Almas: How do you plan to expand your reach and impact?

Boddy Reddy Jr: Our collaboration with Roche will bring Sepsis ImmunoScore to hospitals nationwide through their diagnostic platform. We're also partnering with government agencies and studying real-world implementation to scale our impact.