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- Two breakthrough studies published in Nature Medicine demonstrate how gene signature analysis can revolutionize infection diagnosis and critical care treatment decisions. - The FDA-approved TriVerity test outperformed clinical standards in a 1,222-patient validation study, providing more accurate infection diagnosis and antibiotic guidance within 30 minutes. - Researchers developed the HI-DEF scoring system analyzing over 7,000 blood samples to predict immune system dysfunction and guide targeted treatments for critical illnesses. - The combined platform could enable rapid diagnosis, severity assessment, and personalized treatment recommendations, potentially reducing antibiotic resistance and improving patient outcomes.
- Inflammatix published three landmark studies in Nature Medicine that redefine sepsis diagnosis and treatment through AI-powered immune profiling and consensus frameworks. - The SEPSIS-SHIELD study validated TriVerity's ability to distinguish bacterial from viral infections and predict illness severity in over 1,200 patients with high sensitivity and specificity. - Two new consensus frameworks, HI-DEF and CTS, identified distinct immunological states in sepsis patients, with dysregulated patients showing 5-7 times higher mortality risk. - TriVerity received FDA 510(k) clearance in January 2025 and delivers results in 30 minutes to guide emergency department triage decisions.
- Inflammatix's TriVerity test system has received FDA clearance for emergency triage of patients with suspected acute infection or sepsis, providing rapid results. - The test identifies bacterial and viral infections and evaluates the risk of developing severe illness by measuring the expression of 29 genes. - Clinical studies involving 1,222 patients demonstrated high accuracy in predicting patient outcomes, with AUC scores ranging from 0.77-0.91. - TriVerity aims to improve outcomes, survival rates, and healthcare utilization by offering a precise measure of infection likelihood and risk stratification.
• Inflammatix initiates the TIMED trial (NCT06637904) to assess its TriVerity test for managing patients with suspected acute infection or sepsis. • The TriVerity test analyzes 29 messenger RNAs (mRNAs) to provide rapid insights into the body's immune response to infection, delivering results in about 30 minutes. • The trial aims to enroll 600 patients across emergency departments in Maryland and Illinois, evaluating the test's impact on clinical parameters and healthcare resource utilization. • Inflammatix seeks FDA clearance for TriVerity and Myrna via the breakthrough device designation pathway, potentially improving antimicrobial therapy decisions and reducing hospital stays.
• Inflammatix has initiated the TIMED trial to assess the clinical utility of its TriVerity test in emergency departments for patients with suspected infections. • The trial aims to enroll 600 patients across two U.S. medical centers, evaluating TriVerity's impact on sepsis management and ED disposition times. • TriVerity measures the expression of 29 messenger RNAs to rapidly assess a patient's immune response, aiding in treatment decisions and resource allocation. • The study is being conducted under an FDA Investigational Device Exemption, with results expected to inform future clinical practice and regulatory submissions.
• Inflammatix has raised $57 million to support regulatory filing and commercialization of its TriVerity rapid blood test for acute infection and sepsis. • The TriVerity system measures gene expression levels in blood related to immune response, providing results in about 30 minutes using machine learning. • The FDA granted breakthrough device designation to TriVerity, intended to expedite clearance and Medicare coverage; regulatory submission is already underway. • Inflammatix plans to expand its commercial team and conduct clinical studies while awaiting FDA clearance for the TriVerity test in the coming months.
