John Taylor, Professor of Economics at Stanford University and developer of the "Taylor Rule" for setting interest rates | Stanford University
John Taylor, Professor of Economics at Stanford University and developer of the "Taylor Rule" for setting interest rates | Stanford University
Sepsis, a severe medical condition caused by a dysregulated immune response to infection, is responsible for significant mortality rates globally. The challenge in diagnosing sepsis quickly and accurately has been a persistent issue, often delaying critical treatment decisions. Traditional diagnostic methods can take up to three days to determine the cause of infection, whether bacterial or viral.
In January, the Food and Drug Administration cleared a new test developed by Stanford Medicine's Purvesh Khatri that aims to reduce diagnosis time to approximately 30 minutes. This advancement could potentially transform the treatment landscape for millions of patients annually.
Purvesh Khatri, PhD, emphasizes the urgency in diagnosing sepsis: "Time is of the essence in the proper diagnosis of sepsis." He explains that emergency physicians often administer antibiotics preemptively due to delays in identifying infections as bacterial or viral.
Khatri co-founded Inflammatix with Tim Sweeney, MD, PhD, and Jonathan Romanowsky in 2016. Their company developed TriVerity, a platform evaluating blood samples for 29 genes linked to infection presence and severity. These gene signatures were identified at Stanford by Khatri.
The FDA clearance represents a significant step toward implementing this diagnostic tool in clinical settings. It also validates the machine-learning techniques used to develop it. "We’ve gone from deep skepticism to FDA clearance," said Khatri regarding initial doubts about using public data for research.
The TriVerity test offers three scores indicating infection presence, type (bacterial or viral), and severity within 30 minutes. Its accuracy boasts sensitivities and specificities greater than 95% for extreme score values. Importantly, it reduces false negatives when identifying severely ill patients needing ICU care.
While Inflammatix continues refining the test, Khatri's lab is pursuing further challenges like determining optimal immune-modulatory treatments post-diagnosis.
This development underscores broader implications beyond immediate clinical applications. "This is proof of our concept," stated Khatri about overcoming skepticism towards leveraging public data analysis for creating effective diagnostics.
The FDA clearance marks an important milestone not only for sepsis management but also signals potential shifts in developing future point-of-care diagnostics based on comprehensive data analysis strategies.
###
Alerts Sign-up