Sunnyvale, Calif., Jan. 21: Inflammatix, a leader in advanced host response diagnostics, has achieved a significant milestone with the U.S.
Food and Drug Administration (FDA) granting marketing authorization for its TriVerity Test System. This groundbreaking molecular blood test is designed for patients suspected of acute infections or sepsis. Transforming Emergency Care
The TriVerity test stands out as the first and only molecular test capable of identifying both bacterial and viral infections while also assessing the need for critical care. By employing a precision medicine approach, TriVerity aims to revolutionize emergency triage standards and improve decision-making processes within emergency departments.
Addressing a Critical Need
"Despite substantial investments in healthcare innovation, sepsis mortality rates remain alarmingly high, and it continues to be the costliest diagnosis for healthcare systems," stated Dr. Tim Sweeney, CEO and co-founder of Inflammatix. He highlighted the limitations of existing tests that typically categorize patients simply as "septic or not," emphasizing the complexity of sepsis as a syndrome rather than a fixed disease.
A New Standard for Patient Assessment
TriVerity offers a rapid blood test that measures the expression levels of 29 genes linked to the immune response to infection. It incorporates advanced algorithms powered by artificial intelligence (AI) and machine learning to generate three key scores: the likelihood of bacterial infection, the likelihood of viral infection, and the risk of severe illness requiring intensive interventions within a week.
Alleviating Emergency Department Overcrowding
The introduction of TriVerity is expected to significantly alleviate the challenges faced by hospital systems, particularly in crowded emergency departments where patient wait times can stretch into days or even weeks. With a need to screen numerous patients for every confirmed case of sepsis, TriVerity's rapid and accurate assessment could reduce unnecessary hospital admissions and lengths of stay.
Enhancing Diagnostic Accuracy
The FDA's clearance of TriVerity was based on the SEPSIS-SHIELD study (NCT04094818), which demonstrated high diagnostic and prognostic accuracy across 1,222 patients from 22 sites, regardless of immune status or racial background. Previously designated as a Breakthrough Device in November 2023, only about 10% of such devices receive marketing clearance from the FDA.
A Solution for Emergency Physicians
Dr. John W. Hafner, an emergency medicine physician at OSF HealthCare, remarked on the timeliness of TriVerity's clearance, noting its potential to aid emergency physicians in diagnosing and managing acute infections or sepsis more effectively. The test is particularly valuable for quickly triaging patients who exhibit ambiguous symptoms.
A Vision for Precision Medicine
Hal Paz, from Khosla Ventures, emphasized the transformative nature of TriVerity in enhancing patient care while reducing costs and clinician burnout. Dr. Purvesh Khatri, Co-founder and Chief Scientist at Inflammatix, expressed excitement over the test's accuracy, achieved through over a decade of rigorous data science work that combines rapid testing with insightful data-driven analysis.
The FDA clearance of the TriVerity Test represents a significant advance in the management of acute infections and sepsis. With its innovative approach, Inflammatix is poised to improve patient outcomes and reshape emergency care practices across healthcare systems.
For more information about Inflammatix and the TriVerity Test, visit their official website.
