Inflammatix Receives FDA Clearance for First-in-Class TriVerity™ Test

Inflammatix Receives FDA Clearance for First-in-Class TriVerity™ Test

Inflammatix, a pioneering host response diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity™ Test System (TriVerity), a first-in-class molecular test for patients with suspected acute infection or sepsis. Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status.  

“Despite billions of dollars’ worth of innovation and decades of work, sepsis mortality remains frustratingly high, and sepsis remains the most expensive diagnosis to the healthcare system,” said Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix. “The fundamental problem with existing tests is an outdated focus on labeling patients as ‘septic or not.’ But sepsis is a syndrome, not a disease, and its definition keeps changing. We therefore designed TriVerity to look at its clinically actionable core elements: (1) does this patient have an infection, and (2) how sick are they likely to become?” 

Dr. Sweeney added, “When troponin monitoring came into mainstream practice, it transformed the syndrome of ‘chest pain,’ and outcomes for heart attacks improved dramatically. We think that syndromic acute infections are ready for a similar revolution in care, led by TriVerity.”

TriVerity is a rapid blood test that measures the expression levels of 29 genes associated with the host immune response to infection. The test uses validated algorithms developed applying artificial intelligence (AI)/machine learning to interpret the host response information into three scores that indicate the likelihood of (1) bacterial infection, (2) viral infection, and (3) severe illness (as defined by the need for mechanical ventilation, vasopressors, or renal replacement therapy within seven days).

TriVerity is expected to ease the burden faced by hospital systems, which are plagued by emergency department (ED) overcrowding, and, for those patients admitted, with lengths of stay (LOS) commonly measured not in hours but in days or even weeks.1 A large part of the problem is that for every patient identified with sepsis, typically 20 patients must be screened or tested.2 Faster, more accurate triage of this patient segment may dramatically decrease resource strain, reduce unnecessary hospital admissions and LOS, and free up clinicians to focus on patients who truly need critical interventions. 

That is the gap TriVerity aims to close: by providing a precise measure of infection likelihood and risk stratification (instead of defaulting to a binary “sepsis” label), it helps EDs manage not just patients with sepsis, but also those with common acute infection presentations such as suspected pneumonia, cellulitis, or other infections. The long-term goal is to improve outcomes, survival rates, and healthcare utilization for a broad group of patients.

“FDA clearance of TriVerity comes at an opportune time for today’s overburdened emergency physicians, who now have a precise and reliable tool to facilitate the diagnosis and proper management of acute infections or sepsis,” said 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. “In addition to identifying patients whose severe infections might otherwise have been missed, TriVerity can help quickly triage patients in the ‘grey zone,’ whose signs and symptoms are ambiguous and hard to diagnose.”

The FDA cleared TriVerity based on results from the SEPSIS-SHIELD study (NCT04094818), in which TriVerity yielded diagnostic and prognostic results with a high degree of accuracy in 1,222 enrolled patients across 22 sites, regardless of patients’ immune status or race. The FDA previously granted Breakthrough Device Designation to TriVerity in November 2023. FDA clearance of TriVerity is particularly notable, with only about 10% of designated Breakthrough Devices receiving marketing clearance.3

Hal Paz of Khosla Ventures, a lead investor in Inflammatix, commented, “As a former CEO of multiple large-scale health systems, I’ve seen how slow or inaccurate sepsis diagnosis harms patient care, drives up costs, and contributes to clinician burnout. TriVerity transforms that equation by reducing diagnostic uncertainty, streamlining care, lowering costs, and most importantly improving patient outcomes.”

“TriVerity is a first step towards accurate molecular characterization of acute illnesses,” noted Inflammatix Co-founder and Chief Scientist Purvesh Khatri, PhD, who is also Professor of Medicine at Stanford University. “Its unprecedented accuracy is the result of over a decade of rigorous state-of-the-art data science. We were able to integrate thousands of patient profiles into a set of robust classifiers and were thrilled that the accuracy was exactly in line with our expectations. Our combination of rapid, high-multiplex test results with data-driven insights will usher in the era of precision medicine for critical illnesses in which the immune host response is the determining factor in individualizing care for every patient walking into the emergency department.” 

About the TriVerity™ Test System

The TriVerity™ Test System (“TriVerity”), Inflammatix’s flagship in vitro diagnostic (IVD) test, includes the TriVerity cartridge and the Myrna™ instrument. TriVerity incorporates a panel of 29 patient messenger RNAs (mRNAs) to rapidly “read” the body’s immune response to infection using machine-learning-derived algorithms. TriVerity shows the likelihood of a bacterial infection, a viral infection, and illness severity in adult patients with suspected acute infection or sepsis that present to emergency departments. TriVerity empowers physicians to confidently make care decisions, which could influence the selection of antimicrobial therapy, focused workups with judicious laboratory and imaging orders, and patient admission or discharge disposition.

TriVerity is based on research done at Stanford University by co-founders Tim Sweeney and Purvesh Khatri, including intellectual property exclusively licensed from Stanford University.

About Inflammatix

Inflammatix, Inc., based in Sunnyvale, California, USA, is revolutionizing molecular diagnostics with machine-learning-powered technology to rapidly read a patient’s immune response. Our innovative diagnostics aim to improve patient care and tackle significant public health challenges. Designed for our advanced sample-to-answer isothermal instrument platform, our tests bring the power of precision medicine to the point of care. The company’s funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital Partners, Iberis Capital, and Vesalius BioCapital, and the Stanford-StartX Fund. 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; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract numbers 75A50119C00034, 75A50119C00044, and 75A50122C00069.

TriVerity, Myrna, and Inflammatix are trademarks of Inflammatix, Inc. in the U.S. and other countries and regions.

References

  1. American College of Emergency Physicians. Emergency Department Boarding Crisis Sign-on Letter, November 7, 2022. https://www.acep.org/siteassets/new-pdfs/advocacy/emergency-department-boarding-crisis-sign-on-letter-11.07.22.pdf.
  2. Wang HE, Jones AR, Donnelly JP. Revised National Estimates of Emergency Department Visits for Sepsis in the United States. Crit Care Med. 2017;45(9):1443-1449. doi: 10.1097/CCM.0000000000002538.
  3. U.S. Food and Drug Administration. Breakthrough Devices Program, November 7, 2024.  https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#:~:text=Graph%202:%20Number%20of%20Granted,ABBOTT%20MEDICAL.  

Media Contact 

Reba Auslander, RAliance Communications
917-836-9308
[email protected] 

 

Myrna instrument & cartridge

Inflammatix receives FDA clearance for its TriVerity™ Test, the first and only molecular blood test that can both identify bacterial and viral infections and assess need for critical care, expected to enable timely and confident decision-making for emergency departments.

 

 

 

 

Inflammatix Initiates TriVerity™ for Improved Management of  Emergency Department Patients with Suspected Infections (TIMED) Trial

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]


Myrna instrument & cartridge

The TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument and TriVerity Cartridge.

Inflammatix Initiates TriVerity™ for Improved Management of  Emergency Department Patients with Suspected Infections (TIMED) Trial

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]


Myrna instrument & cartridge

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 

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]


Myrna instrument & cartridge

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 Secures $57 Million to Advance Novel Diagnostic for Patients with Suspected Infections or Sepsis

Fundraise brings lead product, TriVerity™ Test, closer to commercialization following recent submission to FDA.

Sunnyvale, Calif., September 12, 2024 — Inflammatix, a pioneering molecular diagnostics company, announced today the closing of $57 million in Series E financing, led by Khosla Ventures and Think.Health. The funds will support regulatory filing and early commercialization of the company’s lead product, the TriVerity™ Acute Infection and Sepsis Test (TriVerity).

TriVerity is a blood test that is intended to fill a critical need in the emergency department (ED) setting. Each year, 20 million people arrive at the hospital suspected of having an acute infection or sepsis. Recent company-sponsored clinical studies1,2 validate previous research3-5 suggesting that physician assessment and vital-signs-based scoring underestimate severity in up to half of patients suspected of acute infection or sepsis.  With an annual incidence of 2.7 million cases and an annual mortality rate of 350,0006, sepsis is a leading cause of death in U.S. hospitals and costs the Centers for Medicare and Medicaid Services (CMS) $53 billion each year, making it the most costly diagnosis among Medicare beneficiaries.7  

“The newly raised funds will help us to expand our commercial team and plan clinical interventional and health economic studies as we await FDA clearance over the coming months,” said Dr. Timothy Sweeney, CEO and co-founder of Inflammatix. “TriVerity is bringing the promise of machine learning and AI to infection and sepsis care. We hope to help hospitals improve their performance in terms of complying with sepsis detection and treatment protocols and optimizing patient throughput. We greatly appreciate the strong investor confidence in TriVerity and are excited to be very close to offering this novel test to physicians.”

In addition to the leading investors Khosla Ventures and Think.Health, the Inflammatix Series E funding round included participation from Northpond Ventures, D1 Capital Partners, Iberis Capital, Vesalius BioCapital, OSF Healthcare, RAW Ventures, and others. The funding round brings Inflammatix’s total private capital raised to more than $200 million, in addition to more than $50 million in grants and contracts from various government agencies and foundations.

Novel diagnostic approach to spur earlier detection of infection and sepsis

TriVerity, a blood test performed on Inflammatix’s novel Myrna™ Instrument, is uniquely designed to simultaneously determine whether an infection is present, and how likely a patient will need ICU-level interventions. Getting to an accurate diagnosis faster would not only save lives but would also dramatically improve hospital efficiency as well as health system resource allocation. Earlier and more accurate diagnoses may also help hospitals comply with the CMS SEP-1 Bundle, a value-based payments quality measure intended to ensure rapid sepsis detection and treatment. 

“Despite incremental improvements in patient outcomes, the death toll from sepsis remains disproportionately high among vulnerable populations,” said Alex Morgan, partner at Khosla Ventures. “The challenge is that existing diagnostics are not able to detect sepsis early enough to trigger timely intervention, and by the time noticeable clinical symptoms appear, it’s often too late. TriVerity takes a novel approach by detecting the RNA changes that occur in immune cells prior to the manifestation of disease, enabling clinicians to respond faster and sometimes before physiological symptoms are even present. This is a step-change in life-saving care that physicians have been wanting for decades.”

After receiving Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in November 2023 and completing the SEPSIS-SHIELD study [NCT04094818], Inflammatix recently submitted a regulatory packet to the FDA for the TriVerity Test. The company hopes to receive FDA clearance later this year.  

About the TriVerityAcute Infection and Sepsis Test

The TriVerity Acute Infection and Sepsis 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 TriVerity Acute Infection and Sepsis 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.

References

  1. Whitfield N, Michelson EA, Steingrub J, et al. Host response severity score for ICU level care prediction in emergency patients with suspected sepsis.  (2024), SAEM24 Abstracts. Acad Emerg Med, 31: 8-401. https://doi.org/10.1111/acem.14906
  2. Data on file, Inflammatix, Inc.
  3. Askim A, Moser F, Gustad LT, et al. Poor performance of quick-SOFA (qSOFA) score in predicting severe sepsis and mortality – a prospective study of patients admitted with infection to the emergency department. Scand J Trauma Resusc Emerg Med. 2017;25(1):56. doi: 10.1186/s13049-017-0399-4.
  4. Tiwari AT, Jamshed N, Sahu AK, et al. Performance of qSOFA score as a screening tool for sepsis in the emergency department. J Emerg Trauma Shock. 2023;16(1):3-7. doi: 10.4103/jets.jets_99_22.
  5. Freund Y, Lemachatti N, Krastinova E, et al. Prognostic accuracy of Sepsis-3 criteria for in-hospital mortality among patients with suspected infection presenting to the emergency department. JAMA. 2017;317(3):301-308. doi: 10.1001/jama.2016.20329.
  6. Sepsis. U.S. Department of Health and Human Services, National Institutes of Health, National Institute of General Medical Sciences; 2024. https://www.nigms.nih.gov/education/fact-sheets/Pages/sepsis.aspx?ref=prendi-il-controllo-della-tua-salute.com#:~:text=Each%20year%2C%20according%20to%20the,350%2C000%20die%20as%20a%20result.
  7. Frank CE, Buchman TG, Simpson SQ, et al. Sepsis among Medicare beneficiaries: 4. Precoronavirus Disease 2019 Update January 2012-February 2020. Crit Care Med. 2021;49(12):2058-2069. doi: 10.1097/CCM.0000000000005332.

Media Contact

Reba Auslander, RAliance Communications
917-836-9308
[email protected]


Myrna instrument & cartridge

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 Receives Breakthrough Device Designation from FDA for TriVerity™ Acute Infection and Sepsis Test System

Regulatory Milestone Designed to Expedite Path to FDA Clearance and CMS Coverage.

Sunnyvale, Calif., November 28, 2023 — Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s lead product, the TriVerity™ Acute Infection and Sepsis Test System. The TriVerity Test System, currently under development, includes the Myrna™ Instrument and the TriVerity Test and is intended to be used in emergency departments in adult patients with suspected acute infection or suspected sepsis. The TriVerity Test is designed to provide three independent readouts that reflect the likelihood of a bacterial infection, the likelihood of a viral infection, and the risk of severe illness (based on the need for critical organ support* within seven days of presentation to the emergency department).

“We are pleased that the FDA has granted its Breakthrough Device Designation to TriVerity, as it reflects that this novel test system has the potential to help physicians improve on the current standard of care,” said Dr. Timothy Sweeney, CEO and co-founder of Inflammatix. “By reaching this important regulatory milestone, we hope to place TriVerity on an accelerated pathway to FDA clearance, which would allow us to fill an unmet need for rapid, accurate tests for the diagnosis and prognosis of patients with suspected sepsis.”

The FDA established the Breakthrough Devices Program as a voluntary mechanism for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval and marketing authorization.

As a Breakthrough Device, TriVerity is expected to be eligible for the Centers for Medicare & Medicaid Services (CMS) New Technology Add-On Payment (NTAP) program, which will enable future Inflammatix hospital customers to receive a partial subsidy for purchases of TriVerity Acute Infection and Sepsis Tests performed on admitted patients for up to three years. In addition, assuming CMS finalizes its proposed Temporary Coverage for Emerging Technologies (TCET) rule, the TriVerity Test may be eligible for temporary coverage for tests run on discharged Medicare patients for up to four years. CMS is expected to issue its final ruling on TCET in December 2023.

“The potential Medicare reimbursement benefits associated with Breakthrough Designation may expedite implementation of TriVerity in our partner hospitals,” commented Dr. Sweeney. “We continue to engage with payers, hospitals, and other stakeholders on our path to commercial launch.”

* Defined as the need for mechanical ventilation, vasopressors, or renal replacement therapy.

About the TriVerity Acute Infection and Sepsis Test System

The TriVerity™ Acute Infection and Sepsis Test System, the lead product for Inflammatix, includes the Myrna™ Instrument and the TriVerity Test. The TriVerity Test incorporates a panel of 29 messenger RNAs (mRNAs) to “read” the body’s immune response, providing three readouts to facilitate diagnosis and prognosis of adult patients with suspected acute infection or sepsis that present in US emergency departments. Based on internal analysis of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) database, Inflammatix estimates roughly 20 million patients per year visit emergency departments with symptoms consistent with suspected acute infection.

The Myrna Instrument is capable of sample-to-answer quantitation of up to 64 mRNAs from whole blood or other sample types in about 30 minutes. While the first version of the Myrna Instrument will require standard laboratory operation, the company’s roadmap includes the development of a Clinical Laboratory Improvement Amendments (CLIA)-waivable version to enable point-of-care deployments.

The company recently announced the completion of technical development for the TriVerity Test System and has resumed its clinical studies, including its SEPSIS-SHIELD study (NCT04094818) required for 510(k) clearance of the TriVerity Test System by the FDA. The multi-center study has already enrolled 955 of the estimated 1,500 patients targeted. The company estimates study completion and FDA submission to occur in 2024.

The TriVerity Acute Infection and Sepsis Test System is a product in development, is not for sale, and does not have 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, and the Stanford-StartX Fund. 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 US and other countries and regions.

Media Contact

Reba Auslander, RAliance Communications
917-836-9308
[email protected]

Myrna instrument & cartridge

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.