FDA Approves Innovative Sepsis Diagnostic Test Cutting Diagnosis Time

Sepsis, a critical condition arising from a dysfunctional immune response to infection, accounts for approximately one in five global deaths and one in three fatalities within U.S. hospitals. The challenge of quickly identifying the type of infection--be it bacterial, viral, or another pathogen--has long contributed to its high mortality rate, with existing diagnostic methods taking up to three days.

In a significant advancement, a research team from Stanford Medicine led by Purvesh Khatri has developed a groundbreaking test that reduces this diagnosis timeframe to about 30 minutes. This innovation, known as TriVerity, recently gained clearance from the Food and Drug Administration (FDA), marking a pivotal moment for millions of patients who could benefit from faster sepsis diagnosis and treatment.

Khatri, a member of the Institute for Immunity, Transplantation, and Infection as well as the Department of Medicine, emphasizes the urgency of timely intervention. Delays in administering antibiotics can increase mortality rates by 6% to 8% per hour when a bacterial infection is present. Consequently, emergency department practitioners often resort to administering antibiotics preemptively, despite the potential risks associated with unnecessary antibiotic use if the infection is viral or due to other causes.

TriVerity operates by analyzing a blood sample for 29 gene expressions associated with the presence, type, and severity of infection. This test is a product of Khatri's collaboration with Tim Sweeney and Jonathan Romanowsky, who co-founded Inflammatix in 2016 to bring this innovative diagnostic tool to fruition.

Prior to this development, diagnostic approaches predominantly focused on isolating the pathogen responsible for sepsis. However, the immune system's natural defenses make it exceedingly difficult to detect pathogens in the bloodstream, complicating swift diagnosis. Furthermore, sepsis can manifest as either an exaggerated immune response or an inadequate one, depending on various patient factors.

The TriVerity test represents a paradigm shift in sepsis diagnostics. Instead of diagnosing based solely on the presence or absence of infection, the test provides comprehensive insights into whether an infection is present, its type, and its severity. The underlying innovation stems from leveraging diverse public health data to identify gene activation patterns that are consistent across various demographics and medical conditions.

Khatri's team harnessed machine learning techniques to sift through existing public datasets, successfully identifying robust immune signatures indicative of bacterial or viral infections. This approach not only sidesteps the logistical challenges of recruiting a wide-ranging patient population for clinical studies but also underscores the potential of publicly available data in medical research.

With its FDA clearance, TriVerity is set to enhance clinical practices significantly. The test provides emergency department physicians with rapid results, enabling informed decisions regarding patient care. Each of the three key diagnostic scores--indicating infection presence, pathogen type, and infection severity--achieves sensitivity and specificity rates exceeding 95%.

Moreover, the test has demonstrated a notable reduction in false negatives, a critical improvement in identifying patients who may require intensive care. Out of 1,200 patients evaluated during the testing phase, the tool accurately flagged a substantial number who would have been overlooked under conventional diagnostic methods, potentially saving lives.

Inflammatix continues to refine the platform, aiming to enhance treatment protocols further. While the TriVerity test promises rapid and precise diagnoses, the next frontier involves determining the optimal treatment strategies tailored to each patient's specific needs.

This development not only signifies a major leap in sepsis diagnostics but also serves as a testament to the value of utilizing diverse datasets in creating effective medical solutions. The transition from skepticism regarding public data in research to the successful FDA approval of TriVerity illustrates a groundbreaking achievement in the field of health diagnostics.