Inflammatix Initiates TriVerity Test Study 

Molecular diagnostics firm Inflammatix has begun the TIMED trial (TriVerity for Improved Management of Emergency Department Patients with Suspected Infections). The trial is the first interventional study of the TriVerity Test, 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 study is designed to demonstrate the ways in which TriVerity—the company’s lead product—improves management of emergency department (ED) patients suspected of suffering from acute infection or sepsis, compared to standard of care.

“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,” Inflammatix Chief Medical Officer Sam Ajizian, M.D., said. “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 the test has a favorable impact on patient outcomes.”

The TIMED trial aims to enroll 600 patients and is being conducted in the EDs within 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.

“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,” stated John W. Hafner, M.D., TIMED study co-lead investigator, an 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.

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 ED 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 FDA designated TriVerity as a Breakthrough Device in November 2023. The TriVerity Test and Myrna Instrument are currently pending FDA clearance and have not received marketing approval or clearance from regulatory authorities in any jurisdiction.

Inflammatix Inc., a molecular diagnostics company headquartered in Sunnyvale, Calif., is developing 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.

Inflammatix product development has been funded in part with federal funds from the U.S. 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.