SUNNYVALE, Calif., Nov. 11, 2024
First Interventional Study Designed to Demonstrate the Clinical Utility of the TriVerity Test and its Impact on Patient Management
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SUNNYVALE, Calif., Nov. 11, 2024 /PRNewswire/ -- Inflammatix, a pioneering molecular diagnostics company, today announced initiation of the TriVerity™ for Improved Management of Emergency Department Patients with Suspected Infections Trial (the TIMED trial), the first interventional study of the TriVerity™ Test (TriVerity), which measures the expression levels of multiple genes involved in the immune response associated with acute infection status and illness severity. The pre/post-interventional use trial is designed to demonstrate how TriVerity, the company's lead product, improves management of patients presenting to the emergency department (ED) with suspected acute infection or sepsis, compared to standard of care.
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"As the first interventional study to demonstrate the clinical utility of TriVerity, the TIMED trial will provide important information on how the test impacts patient management in the emergency setting," commented Sam Ajizian, MD, chief medical officer, Inflammatix. "Following the recently completed SEPSIS-SHIELD study, which is under FDA review to assess the test's clinical performance, the TIMED trial seeks to demonstrate that the test has a favorable impact on patient outcomes."
The TIMED trial, which aims to enroll 600 patients, is being conducted in the EDs of The Johns Hopkins University (JHU) Medical Center in Baltimore, Md., and OSF HealthCare Saint Francis Medical Center in Peoria, Ill. The primary endpoints are compliance with the Severe Sepsis and Septic Shock Management (SEP-1) Bundle, a Centers for Medicare and Medicaid Services (CMS) guideline for implementing timely sepsis recognition and early intervention; and time to final ED disposition order (admission or discharge). Secondary outcomes to be measured include appropriate use of antibiotics and antivirals, ED length of stay, diagnostic ordering practices (i.e., impact of TriVerity on use of other diagnostics), hospital admission rates, and total hospital costs. Information about the trial is available at ClinicalTrials.gov, under the trial identifier number NCT06637904.
"For many patients whose presentations are difficult to differentiate, the limitations of existing diagnostics make it extremely challenging to diagnose the presence, type, and severity of infection," said TIMED study co-lead investigator John W. Hafner, MD, emergency medicine physician at OSF HealthCare and program director, research director, and clinical professor of Emergency Medicine at the University of Illinois College of Medicine in Peoria. "That challenge has multiple ramifications, including suboptimal compliance with the SEP-1 Bundle and lengthy emergency department wait times and stays. The TIMED trial, with its pre- and post-interventional design, will allow us to evaluate the impact of the novel TriVerity test on these and other important clinical parameters in real time."
The TIMED trial is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). It is open to patients with suspected infection and tachycardia (heart rate >100 beats per minute) or fever (>38° Celsius), who will be screened and enrolled in the ED waiting room. Approximately 300 patients will be enrolled in each of the pre- and post-intervention arms. Participants in the pre-intervention arm, treated with standard of care, will be gathered from a retrospective database using propensity matching. Participants in the post-intervention arm will have blood samples collected and immediately analyzed via TriVerity. The TriVerity test results will inform treatment decisions based on standard guidance for interpretation and resulting management actions.
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 and Myrna Instrument are not for sale. They are currently pending FDA clearance and have 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.
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SOURCE Inflammatix
