US-based diagnostics company Inflammatix has received the US Food and Drug Administration (FDA) marketing authorisation for its TriVerity test system (TriVerity).
TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, leveraging accurate measurements of a patient’s immune response.
The rapid diagnostic test is designed to measure the expression levels of 29 genes associated with the host’s immune response to infection.
It also leverages validated algorithms developed using artificial intelligence/machine learning (AI/ML) to interpret the host response information into three scores.
The scores indicate potential bacterial infection, viral infection, and severe illness, which may need mechanical ventilation, vasopressors, or renal replacement therapy within seven days.
TriVerity is intended for use in patients with suspected acute infection or sepsis and provides clinicians with a rapid and holistic snapshot of a patient’s status.
The rapid blood helps physicians in selecting antimicrobial therapy, focused workups with judicious laboratory and imaging orders, and patient admission or discharge disposition.
In November 2023, TriVerity secured FDA granted Breakthrough Device Designation.
Inflammatix CEO and co-founder Tim Sweeney said: “Despite billions of dollars’ worth of innovation and decades of work, sepsis mortality remains frustratingly high, and sepsis remains the most expensive diagnosis to the healthcare system.
“The fundamental problem with existing tests is an outdated focus on labelling patients as ‘septic or not.’ But sepsis is a syndrome, not a disease, and its definition keeps changing.
“We therefore designed TriVerity to look at its clinically actionable core elements: (1) does this patient have an infection, and (2) how sick are they likely to become?
“When troponin monitoring came into mainstream practice, it transformed the syndrome of ‘chest pain,’ and outcomes for heart attacks improved dramatically. We think that syndromic acute infections are ready for a similar revolution in care, led by TriVerity.”
TriVerity builds on research conducted at Stanford University by Inflammatix co-founders and is based on intellectual property exclusively licensed from Stanford University.
The in vitro diagnostic (IVD) test comprises the TriVerity cartridge and Myrna instrument.
It incorporates a panel of 29 patient mRNAs to rapidly measure the body’s immune response to infection using AI/ML algorithms.
The US FDA approved the TriVerity test based on results from the SEPSIS-SHIELD study in 1,222 patients across 22 sites, regardless of patients’ immune status or race.
In the study, TriVerity showed diagnostic and prognostic results with the highest accuracy.
TriVerity is expected to enhance the burden on hospital systems, due to overcrowded emergency departments (EDs) and extended patient lengths of stay (LOS).
Inflammatix co-founder and chief scientist Purvesh Khatri said: “TriVerity is a first step towards accurate molecular characterisation of acute illnesses. Its unprecedented accuracy is the result of over a decade of rigorous state-of-the-art data science.
“We were able to integrate thousands of patient profiles into a set of robust classifiers and were thrilled that the accuracy was exactly in line with our expectations.
“Our combination of rapid, high-multiplex test results with data-driven insights will usher in the era of precision medicine for critical illnesses in which the immune host response is the determining factor in individualising care for every patient walking into the emergency department.”
