- The health tech firm Prenosis revealed on Wednesday that the U.S. Food and Drug Administration has granted approval for its AI-driven diagnostic tool designed for sepsis.
- Sepsis arises when the body reacts severely to an infection, posing a significant challenge for accurate diagnosis.
- Prenosis’ innovative solution, known as Sepsis ImmunoScore, has been greenlit by the FDA through the De Novo pathway, marking a pioneering achievement in this domain.
Located in White Oak, Maryland, the U.S. Food and Drug Administration headquarters displays prominent signage, as observed on August 29, 2020.
The cutting-edge artificial intelligence-powered diagnostic tool for sepsis, developed by the health technology company Prenosis, has clinched the distinction of being the inaugural recipient of approval from the U.S. Food and Drug Administration.
Sepsis, characterized by an exaggerated immune response to an infection, is a condition notorious for its diagnostic complexity and potentially fatal outcomes. According to the Centers for Disease Control and Prevention, over 350,000 adults afflicted with sepsis either succumb during hospitalization or are transferred to hospice care annually. The early identification of sepsis is critical due to the rapid deterioration that patients can experience.
Prenosis’ groundbreaking tool, Sepsis ImmunoScore, employs a comprehensive approach utilizing 22 distinct parameters such as temperature, heart rate, and cell counts to aid healthcare professionals in evaluating a patient’s sepsis risk, as reported by CNBC. Traditionally, medical staff would need to monitor each parameter individually, whereas Prenosis’ solution streamlines this process by leveraging AI to assess all markers simultaneously. The tool furnishes an overall risk score along with four risk categories that are indicative of a patient’s likelihood of deterioration, as outlined in a press release.
Constructed on Prenosis’ Immunix platform, Sepsis ImmunoScore draws from a vast dataset comprising over 100,000 blood samples sourced from 25,000 diverse patients, the release elaborated.
The seamless integration of the tool into electronic health records allows clinicians to efficiently create and manage patients’ medical records. Prenosis underscores that embedding Sepsis ImmunoScore within existing workflows ensures user-friendliness and accessibility. Clinicians are presented with a clear display detailing the specific parameters utilized in calculating the overall risk score.
Prenosis’ pioneering solution underwent the FDA’s De Novo pathway for approval, signifying that no analogous tool had been endorsed by the agency before. This milestone marks a significant triumph for the ten-year-old startup based in Chicago.
While Prenosis leads the pack in securing FDA approval for its AI-driven sepsis diagnostic tool, several other entities have also developed and introduced similar solutions. For instance, Johns Hopkins University has devised an AI system aimed at swiftly identifying sepsis symptoms. A study published in Nature Medicine in 2022 revealed that in severe cases, the university’s AI model detected sepsis approximately six hours earlier than conventional methods.
Epic Systems, a prominent healthcare software provider, has likewise created an AI-powered sepsis prediction tool, albeit facing substantial critique in recent years. Despite its widespread adoption in hundreds of U.S. hospitals, a study published in JAMA Internal Medicine in 2021 highlighted the model’s poor predictive performance concerning sepsis. The study raised fundamental concerns regarding national sepsis management practices in light of the model’s shortcomings.
In response to the criticism, Epic defended its technology in a blog post, citing improvements in sepsis mortality rates attributed to its solutions. Nonetheless, Epic reportedly revamped its sepsis model in the subsequent year to enhance its efficacy, as reported by Stat News.
Prenosis informed CNBC that although the Sepsis ImmunoScore was ready for market deployment approximately three years ago, the company refrained from commercializing the product without FDA approval. Prioritizing safety considerations and ensuring the technology’s harm-free integration, Prenosis opted to collaborate with regulators.
Furthermore, in September 2022, the FDA updated its guidelines for companies and highlighted specific device software functions warranting regulatory oversight. The agency emphasized that software analyzing patient-specific medical data to detect life-threatening conditions like stroke or sepsis falls within this regulatory purview.
In essence, the FDA encourages companies developing sepsis detection tools to seek official authorization.
Prenosis detailed its rigorous efforts spanning 18 months to demonstrate the safety and efficacy of Sepsis ImmunoScore to the FDA. With the agency’s seal of approval secured, the company plans to embark on additional studies showcasing the tool’s accuracy and impact on clinical decision-making. Prenosis aims to introduce the tool to hospitals in the U.S. initially, with future plans to expand its availability to healthcare facilities worldwide.
