Inflammatix Inc. has secured FDA clearance for its TriVerity test system, a molecular blood test designed for rapid triage of patients with suspected acute infection or sepsis in emergency departments. This clearance marks a significant advancement in the diagnosis and management of severe infections.
The TriVerity test is designed to measure the expression of 29 genes that regulate a person’s response to infection. Within approximately 30 minutes, the test can identify whether a patient has a bacterial or viral infection and assess the likelihood of developing severe illness, such as sepsis. Sepsis, a condition characterized by the body's overreaction to an infection, affects up to 2% of all hospitalizations and occupies around 25% of intensive care unit beds.
Clinical Validation and Accuracy
The FDA clearance was supported by data from the SEPSIS-SHIELD study (NCT04094818), which included 1,222 patients across 22 sites. The study demonstrated that TriVerity accurately predicted patient outcomes, with area under the receiver operator curve (AUC) scores ranging from 0.77 to 0.91. This level of accuracy underscores the test's potential to improve clinical decision-making.
Addressing Unmet Needs in Sepsis Diagnosis
Traditional approaches to sepsis diagnosis often focus on binary classifications, labeling patients as either "septic" or "not septic." However, sepsis is a complex syndrome with varying clinical presentations. TriVerity addresses this challenge by providing a more nuanced assessment of infection likelihood and risk stratification.
According to Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix, the fundamental problem with existing tests is an outdated focus on labeling patients as 'septic or not.' He stated, "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?"
How TriVerity Works
The TriVerity test system includes the TriVerity cartridge and the Myrna instrument. The test analyzes a panel of 29 messenger RNAs (mRNAs) to rapidly assess the body's immune response to infection using machine-learning-derived algorithms. This approach allows physicians to confidently make care decisions, including the selection of antimicrobial therapy, laboratory and imaging orders, and patient disposition.
Implications for Patient Care
John W. Hafner, MD, emergency medicine physician at OSF HealthCare, noted that TriVerity can help quickly triage patients in the 'grey zone,' whose signs and symptoms are ambiguous and hard to diagnose. The test's ability to identify patients whose severe infections might otherwise have been missed can lead to improved outcomes and survival rates.
Future Directions
Inflammatix is also developing other precision tests, including one to assess patient response to sepsis therapy and a fingerstick test for bacterial or viral infection detection in primary care settings. These advancements reflect the company's commitment to revolutionizing molecular diagnostics and improving patient care through precision medicine.
