TriVerity
by Inflammatix
· Based in United States →
— Empowering emergency clinicians to rapidly recognize and act early on acute infections with unparalleled precision.
Regulatory Status Disclosed
Overview
The TriVerity™ Test System, developed by Inflammatix, is a pioneering molecular diagnostic test that leverages artificial intelligence (AI) and machine learning (ML) to interpret a patient’s host immune response. It is designed to aid emergency department physicians in the rapid diagnosis and prognosis of adult patients with suspected acute infection or sepsis.
The system comprises the TriVerity cartridge and the Myrna™ instrument. It performs a rapid blood test, measuring the expression levels of 29 genes associated with the host immune response to infection. Within approximately 30 minutes, the AI/ML algorithms analyze these biomarkers to provide three critical scores: the likelihood of a bacterial infection, the likelihood of a viral infection, and the likelihood of severe illness (defined by the need for mechanical ventilation, vasopressors, or renal replacement therapy within seven days).
TriVerity aims to provide clinicians with a precise and reliable tool to facilitate the diagnosis and proper management of acute infections or sepsis, helping to differentiate between bacterial, viral, and non-infectious conditions. This enables faster, more confident treatment decisions, potentially improving patient outcomes, reducing unnecessary antibiotic use, and streamlining care in overburdened emergency departments.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Rapid blood test for acute infections and sepsis
- Measures expression levels of 29 host immune response genes
- Utilizes AI/machine learning algorithms for interpretation
- Provides three scores: likelihood of bacterial infection, viral infection, and severe illness
- Assesses likelihood of 7-day need for mechanical ventilation, vasopressors, or renal replacement therapy
- Rapid turnaround time of approximately 30 minutes
- Point-of-care deployment with the Myrnau2122 Instrument and TriVerity cartridge
- Aids in differentiating bacterial, viral, and non-infectious illness
- Designed to be CLIA-waivable
- Clinically proven for high accuracy and precision
Use Cases
- Aid in diagnosis and prognosis of adult patients with suspected acute infection or sepsis in emergency departments
- Differentiate between bacterial infections, viral infections, and non-infectious illness
- Determine the likelihood of severe illness (need for critical organ support within seven days)
- Facilitate faster and more confident treatment decisions for emergency physicians
- Improve patient outcomes and reduce unnecessary antibiotic use and hospital resources
- Streamline care and lower costs in acute infection management
What Physicians Need to Know
LIS/LIMS Integration
TriVerity's Myrnau2122 instrument offers multiple LIS connectivity options for seamless integration with laboratory information systems.
Supported Assay Types
The TriVerityu2122 Test System measures a panel of 29 patient messenger RNAs (mRNAs) to interpret the body's immune response. It provides scores for the likelihood of bacterial infection, viral infection, and all-cause illness severity in adult patients with suspected acute infection or sepsis.
QC/QA Features
The system utilizes validated algorithms and machine learning, demonstrating high sensitivity and specificity. Inflammatix emphasizes robust analytical and clinical validation, with the TriVerity test being clinically proven to be better than the standard of care.
Result Interpretation AI
TriVerity leverages machine learning and artificial intelligence (AI) to interpret host-response information from mRNA panels. It uses machine-learning-derived algorithms to generate three actionable scores for infection type and severity.
Critical Value Alerts
The test provides three critical scores: likelihood of bacterial infection, viral infection, and the risk of progression to severe illness (defined as needing mechanical ventilation, vasopressors, and/or renal replacement therapy within seven days). This offers prognostic clarity to empower rapid clinical decisions.
Instrument Interfaces
The TriVerityu2122 Test System includes the Myrnau2122 instrument, a compact (11.5-inch bench space) benchtop, cartridge-based, sample-to-answer analyzer. It is designed for ease of use with minimal hands-on time and requires no regular or preventative maintenance, also offering remote notification capabilities.
Reference Range Intelligence
Instead of traditional reference ranges, TriVerity provides AI-driven 'likelihood' scores for bacterial infection, viral infection, and illness severity, interpreting the immune response into actionable clinical insights.
Turnaround Time Impact
TriVerity is a rapid blood test designed for early actionability, delivering results in approximately 30 minutes. This quick turnaround time aims to enable faster, more confident decision-making in emergency departments, potentially improving patient outcomes and reducing costs.
Microbiology ID Support
The system differentiates between the likelihood of bacterial and viral infections by interpreting the host's immune response. It does not perform direct pathogen identification but provides crucial information to guide antimicrobial therapy selection.
Physician Tip
TriVerity offers rapid, AI-powered insights into infection type (bacterial vs. viral) and illness severity, enabling faster, more confident treatment and disposition decisions in the Emergency Department. The prognostic clarity on illness severity can guide critical care needs and resource allocation, influencing antimicrobial therapy selection and judicious use of further diagnostics. This test is particularly valuable when time is critical for patients with suspected acute infection or sepsis.
The Myrnau2122 instrument, part of the TriVerity system, is a compact benchtop analyzer with multiple LIS connectivity options, facilitating seamless integration into existing laboratory and hospital information systems. Its sample-to-answer design and minimal maintenance requirements make it suitable for near-patient use, streamlining workflow and reducing hands-on time.
Details
| Category | Lab & Diagnostics, Triage & ER/ICU AI |
| Pricing | Unknown |
| Deployment | On-premise, utilizing the Myrna™ Instrument. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The TriVerity™ Test System received U.S. Food and Drug Administration (FDA) marketing authorization (K241676) in January 2025. It was previously granted Breakthrough Device Designation by the FDA in November 2023. |
| Integrations | |
| EHR | Not specified |
| Specialties | Critical Care, Emergency Medicine, Infectious Disease |
Ratings & Reviews
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Press & Coverage
Medical Economics
FDA clears TriVerity test to identify and assess acute sepsis and other infections
Inflammatix received U.S. Food and Drug Administration (FDA) marketing authorization for TriVerity, a molecular test that identifies bacterial and viral infections and assesses illness severity in patients with suspected acute infection or sepsis. This test measures 29 genes related to immune response and uses machine learning to generate scores for bacterial infection, viral infection, and severe illness.
2025-01
MedTech Innovator
Inflammatix's TriVerityu2122 Test Secures NTAP Reimbursement from CMS for First-in-Class Severity Score Working in Concert with Bacterial and Viral Insights
Inflammatix announced that its TriVerityu2122 Test has been granted New Technology Add-On Payment (NTAP) reimbursement by the Centers for Medicare & Medicaid Services (CMS) for fiscal year 2026. This recognition highlights the test's unique clinical utility in rapidly triaging patients with suspected infection or sepsis.
2025-08
Inflammatix (via PR Newswire)
Inflammatix Receives Breakthrough Device Designation from FDA for TriVerityu2122 Acute Infection and Sepsis Test System
Inflammatix, Inc. announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its TriVerityu2122 Acute Infection and Sepsis Test System. This designation is expected to accelerate the path to FDA clearance and potential CMS coverage.
2023-11
Inflammatix
Inflammatix Presents Data at ACEP24 Showing High Diagnostic and Prognostic Accuracy of its TriVerityu2122 Test Regardless of Patient Immune Status
Inflammatix presented data at the 2024 Scientific Assembly of the American College of Emergency Physicians (ACEP24) demonstrating the high diagnostic and prognostic accuracy of the TriVerityu2122 Test. The data showed that the test's accuracy is not affected by the patient's immune status.
2024-10
Journal of Clinical Microbiology (via PR Newswire)
Inflammatix Data in Journal of Clinical Microbiology Validate Accuracy, Robustness, and Ease of Use of TriVerityu2122 Test System
Inflammatix announced the publication of analytical data in the Journal of Clinical Microbiology (JCM) validating the TriVerityu2122 Test System. The data highlight the test's high accuracy, precision, fast turnaround time, and ease of use for triaging patients with suspected acute infection or sepsis.
2025-09
Inflammatix (via PR Newswire)
Inflammatix Receives FDA Clearance for First-in-Class TriVerityu2122 Test
Inflammatix announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerityu2122 Test System. This first-in-class molecular test provides highly accurate bacterial-viral infection scoring and an all-cause illness severity risk evaluation for patients with suspected acute infection or sepsis.
2025-01
Inflammatix (via PR Newswire)
Inflammatix Ships TriVerityu2122 Test Cartridges and Myrnau2122 Instruments to the U.S. Military
Inflammatix announced the shipment of TriVerityu2122 cartridges and Myrnau2122 instruments to the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). This initiative aims to facilitate the differentiation of bacterial infections, viral infections, and non-infectious illness within military settings.
2025-03
Inflammatix (via PR Newswire)
Inflammatix Announces Three Landmark Publications in Nature Medicine that Redefine Acute Infection and Sepsis Diagnosis and Treatment
Inflammatix announced the publication of three manuscripts in Nature Medicine that aim to redefine how patients with suspected sepsis are diagnosed and treated. These publications include pivotal results from the SEPSIS-SHIELD study, validating TriVerityu2122 as a breakthrough molecular test.
2025-09
Videos
Product demos, reviews, and walkthroughs for TriVerity.
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Frequently Asked Questions
The TriVerity Test System uses AI/machine learning to interpret the host immune response by measuring 29 gene expression levels from a blood sample. This provides three scores indicating the likelihood of bacterial infection, viral infection, and severe illness, helping physicians make faster, more confident treatment decisions in emergency departments.
The TriVerity Test System received FDA marketing clearance in January 2025 and was designated a Breakthrough Device in November 2023, indicating its regulatory approval for clinical use. While specific data privacy measures like HIPAA compliance are not detailed for the test itself, as an in vitro diagnostic, it operates within existing healthcare system compliance frameworks for patient data handling.
Current alternatives often involve traditional biomarkers and clinical assessments, which can be less precise in differentiating between bacterial and viral infections or predicting illness severity. TriVerity offers a rapid, AI-powered molecular blood test that provides objective insights into the patient's immune response within approximately 30 minutes, aiming to improve upon the limitations of existing diagnostics.
While specific pricing details are not publicly available, the TriVerity test is positioned to reduce healthcare costs by improving patient triage, decreasing unnecessary antibiotic use, shortening emergency department length of stay, and potentially avoiding costly payment denials. It aims to provide a cost-effective solution by optimizing resource utilization and patient outcomes.
The TriVerity test is indicated for adult patients with suspected acute infection or sepsis presenting to emergency departments and is intended for use in conjunction with clinical assessments and other laboratory findings. Exclusions in trials have included patients with recent systemic antibiotic/antiviral/antifungal treatment, those receiving palliative/hospice care, prisoners, mentally disabled, or those unable to give consent.
Clinical studies, including the SEPSIS-SHIELD study, have demonstrated high sensitivity and specificity for the TriVerity test in distinguishing bacterial from viral infections and predicting illness severity. Analytical data published in the Journal of Clinical Microbiology also validate its accuracy, precision, and reproducibility.
The TriVerity Test System, run on the Myrnau2122 Instrument, is designed for ease of use with minimal operator hands-on time (under 1 minute per test) and a rapid turnaround time of approximately 30 minutes. This makes it ideally suited for integration into hospital laboratories and emergency departments to support clinical decision-making.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18
Investors who backed TriVerity
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