Inflammatix Initiates TriVerity™ for Improved Management of Emergency Department Patients with Suspected Infections (TIMED) Trial
First interventional study designed to demonstrate the clinical utility of the TriVerity test and its impact on patient management
Sunnyvale, Calif., November 11, 2024 — 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.
“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.
Media Contact
Reba Auslander, RAliance Communications
917-836-9308
[email protected]
The TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument and TriVerity Cartridge.
Inflammatix Adds MedTech Veteran as First General Counsel
Inflammatix Adds Three MedTech Industry Veterans to Executive Leadership Team
Sam Ajizian, MD (Chief Medical Officer), Jamie Lewis (Chief Commercial Officer), and Laura Spencer Garth (General Counsel) Hired to Advance Commercialization of TriVerity™ Test
Sunnyvale, Calif., October 10, 2024 — Inflammatix, a pioneering molecular diagnostics company, today announced the expansion of its executive leadership team to oversee launch planning for the company’s lead product, the TriVerity™ Test (TriVerity). With the hiring of Sam Ajizian, MD, as Chief Medical Officer; Jamie Lewis as Chief Commercial Officer; and Laura Spencer Garth as General Counsel, the company adds three seasoned executives with extensive experience in bringing novel medical technologies to market.
“We are excited to add these talented industry veterans to our team as TriVerity continues to advance toward regulatory clearance and commercialization,” said Dr. Timothy Sweeney, CEO and co-founder of Inflammatix. “Sam, Jamie, and Laura are highly experienced leaders in their respective areas of expertise, and they share our passion for promoting game-changing medical innovations and addressing significant gaps in patient care. Their contributions will be crucial to the commercialization of TriVerity, which we aim to bring to market upon FDA clearance.”
Dr. Sam Ajizian joins Inflammatix after spending nearly 10 years at Medtronic, where he served as chief medical officer in the Acute Care and Monitoring businesses, which reached $2 billion in global revenues. In that role he oversaw a team of clinical and medical professionals that served over 115 million patients a year in more than 70 countries. As a medical leader he drove clinical research, medical education, and thought-leader management. Before serving in multiple roles at Medtronic, Dr. Ajizian practiced medicine and was an associate professor of Pediatric Critical Care at Wake Forest University School of Medicine. Among other past clinical posts, Dr. Ajizian was an F-16 flight surgeon for the United States Air Force. At Inflammatix, Dr. Ajizian will oversee medical aspects of the planned TriVerity Test launch including building a team of medical science liaisons responsible for educating emergency physicians, lab technicians, and hospital personnel on the appropriate use of TriVerity and the Myrna™ Instrument. He will also lead clinical evidence development for the TriVerity Test along with his clinical operations and biostatistics teams.
A commercial sales executive and a strategic advisor with a proven track record of leading high-performing teams and building successful companies, Jamie Lewis will build and manage the TriVerity commercial organization. She designed and operationalized the strategy and commercial infrastructure that led Outset Medical to a successful IPO in September 2020. Previously, she served in various leadership roles at Intuitive Surgical, growing sales and market development efforts during the high-adoption phase of surgical robotics. More recently, Ms. Lewis co-founded Matter Solutions, a technology platform that is driving a coordinated care approach for providers and healthcare systems to offer virtual mental and behavioral healthcare services at scale. Ms. Lewis graduated from The Ohio State University and was team captain and a four-year starter on the Ohio State basketball team. She was the first Ohio State player drafted by the WNBA’s Washington Mystics.
With over 15 years of broad corporate counseling and litigation experience, Ms. Spencer Garth is a seasoned in-house thought leader and strategic legal advisor in the medical device industry. She previously served as general counsel of Stereotaxis and Veran Medical Technologies (acquired by Olympus in 2020). Prior to her corporate roles, Ms. Spencer Garth was a litigator and trial attorney at Dolley Law LLC and Bryan Cave Leighton Paisner LLP, where she counseled clients in high-stakes commercial, labor, and employment disputes across a variety of industries. At Inflammatix, Ms. Spencer Garth will lead the legal and compliance functions for the company. She obtained her Juris Doctor degree from Saint Louis University School of Law.
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.
Media Contact
Reba Auslander, RAliance Communications
917-836-9308
[email protected]
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.
Inflammatix Presents Data at ACEP24 Showing High Diagnostic and Prognostic Accuracy of its TriVerity™ Test Regardless of Patient Immune Status
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
917-836-9308
[email protected]
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.