Sunnyvale, Calif., October 1, 2024 — Inflammatix, a pioneering molecular diagnostics company, today presented data demonstrating the high diagnostic and prognostic accuracy of the company’s lead product, the TriVerity™ Test (TriVerity). In an oral presentation at the 2024 Scientific Assembly of the American College of Emergency Physicians (ACEP24) in Las Vegas, Nev., Inflammatix researchers reported that the accuracy of TriVerity is not affected by the patient’s immune status, an important consideration given the high risk of severe infection and sepsis among immunocompromised patients.
“For emergency physicians, the pressure to accurately diagnose an individual with suspected infection is heightened when the patient is immunocompromised, as a misdiagnosis can have catastrophic consequences,” said Sam Ajizian, MD, Chief Medical Officer at Inflammatix. “Our data show that TriVerity yields diagnostic and prognostic results with a high degree of accuracy, regardless of the patient’s immune status. Historical biomarkers in this space have demonstrated inferior performance with immunocompromised patients. The findings suggest that emergency physicians should be able to use TriVerity with great confidence when evaluating patients across the spectrum of diagnoses, severities, and comorbidities associated with acute infection or sepsis.”
Inflammatix researchers presented an interim analysis of data from the SEPSIS-SHIELD study (NCT04094818), a multicenter, prospective clinical trial that enrolled adult patients with suspected acute infection or suspected sepsis who presented to emergency departments (EDs) in the United States and Europe. Investigators tested blood samples from participating patients using TriVerity to generate three scores (bacterial, viral, and illness severity) in five discrete interpretation bands (Very low, Low, Moderate, High, and Very high) in about 30 minutes. They evaluated bacterial and viral score accuracy against clinically adjudicated true infection status, and evaluated severity scores against the 7-day need for mechanical ventilation, vasopressors, and/or renal replacement therapy (“ICU-level care”). The investigators also calculated sensitivity and specificity for each interpretation band.
Among a subset of 933 enrolled patients, 149 were identified as immunocompromised (IC), including those with cancer, solid-organ and other transplants, HIV/AIDS, and other types of immunosuppression (e.g., autoimmune disease, steroid use). Of the 88 IC patients with available infection status, 69 (78%) were adjudicated as bacterial, eight (9%) as viral, and 11 (13%) as non-infected. For the Very low bands, the sensitivity of the bacterial, viral, and severity scores for the IC patients was 96%, 100%, and 100%, respectively. Those results compared favorably to the Very low band results for immunocompetent (NIC) patients, for whom the corresponding sensitivities were 96%, 95%, and 93%. For the Very high bands, the specificity of the bacterial (89%) and severity (89%) scores was lower in the IC patients than in the NIC patients (96% for both scores), while the specificities of the viral scores were similar in both groups (99%).
“The interim SEPSIS-SHIELD data presented at ACEP24 demonstrate the promise of TriVerity in facilitating diagnosis of bacterial and viral infections and the prediction of illness severity in both immunocompromised and immunocompetent patients,” commented Dr. Ajizian. “Further results from this study will add to the growing body of clinical evidence supporting the use of this investigational diagnostic tool in the emergency setting.”
About the TriVerity™ Test
The TriVerity Test (TriVerity), Inflammatix’s lead product, is performed on the Myrna™ Instrument, the company’s proprietary, cartridge-based, benchtop analyzer. TriVerity is a blood test that measures 29 messenger RNAs (mRNAs) to rapidly “read” the body’s immune response to infection using machine learning-derived algorithms. The test is designed to inform on the two “axes” of sepsis — presence of infection and risk of progression to severe illness — in adult patients with suspected acute infection or sepsis in the emergency department setting. TriVerity thus aims to help physicians to confidently make treatment decisions, including selection of antimicrobial therapy, administering additional diagnostic testing, and whether to admit or discharge the patient.
The Myrna Instrument is capable of multiplex sample-to-answer quantitation of mRNAs in about 30 minutes. With its less than one-minute operator hands-on time and simple maintenance, the Myrna Instrument is designed for ease of use and low resource requirements.
The U.S. Food and Drug Administration (FDA) designated TriVerity as a Breakthrough Device in November 2023. The TriVerity Test is not for sale. It is currently pending FDA clearance and has not received marketing approval or clearance from regulatory authorities in any jurisdiction.
About Inflammatix
Inflammatix, Inc., a pioneering molecular diagnostics company headquartered in Sunnyvale, California, USA, is developing novel diagnostics that rapidly read a patient’s immune system to improve patient care and reduce major public health burdens. The Inflammatix tests will be developed to run on the company’s sample-to-answer isothermal instrument platform, enabling the power of precision medicine at the point of care. The company’s funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital, Iberis Capital, and Vesalius BioCapital. For more information, please visit www.inflammatix.com and follow the company on LinkedIn and X (formerly Twitter) at @Inflammatix_Inc).
Inflammatix product development has been funded in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Nos. 75A50119C00034 and 75A50119C00044.
TriVerity, Myrna, and Inflammatix are trademarks of Inflammatix, Inc. in the U.S. and other countries and regions.
Media Contact
Reba Auslander, RAliance Communications
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The TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument and TriVerity Cartridge, has reached an important milestone with completion of technical development.