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Inflammatix Aims for 2024 Launch of 30-Minute Sepsis and Acute Infection Test


NEW YORK – Having secured US Food and Drug Administration breakthrough device designation, Stanford University spinout Inflammatix aims to launch within a year its blood test for 30-minute assessment of infection type and severity in hospital emergency departments.

The Sunnyvale, California-based firm said earlier this month that it had completed technical development of its point-of-care TriVerity Acute Infection and Sepsis Test System, which is used in conjunction with clinical assessments and other laboratory findings to aid differentiation of bacterial infections, viral infections, and noninfectious disease as well as predict disease progression in adult patients who have suspected acute infections or sepsis.

Company officials said Tuesday that the FDA had granted breakthrough device designation for that system, which will help them accelerate commercialization in the US. The firm hopes to launch the test in the fourth quarter of 2024.

Tim Sweeney, Inflammatix cofounder and CEO, said the cartridge-based TriVerity test is designed to be one of the first blood tests administered in emergency departments during triage of patients with suspected acute infections or sepsis.

"The idea is to use it early in the process of patient care where better information about the presence or absence of a bacterial infection, the presence or absence of a viral infection, and risk estimation of the need for escalated care — in particular, ICU-level care — becomes critical in further decision-making for the patient and physician," Sweeney said.

The test system involves mRNA extraction and isothermal amplification on a disposable test cartridge that is designed for use in the company's Myrna instrument, which is used to determine gene expression in whole blood using quantitative real-time RT-LAMP. It uses a panel of 29 mRNA biomarkers to gauge a patient's immune response, and algorithms developed with machine learning are used to interpret the results.

The TriVerity test is used to generate three scores for each patient on the likelihood that the patient has a bacterial infection, a viral infection, and a severe illness that will require interventions including mechanical ventilation, vasopressors, and renal replacement therapy within the following seven days.

The firm also said that the Myrna instrument provides a foundation for the eventual commercialization of a series of tests, providing the capacity for sample-to-answer quantitation of up to 64 mRNA biomarkers from whole blood or other sample types in about 30 minutes. The company is also continuing development of its fingerstick sample-based BacVerity test for bacterial and viral infections and has plans for a blood-based sepsis therapy response test, a nasal swab-based multiplex respiratory viral infection test, and a blood-based myocardial injury test for detection of a heart attack.

Sweeney said the work behind the sepsis and acute infection test and the Myrna instrument stretches back to the start of his studies in late 2013 at Stanford University into the diagnostic potential of host gene expression. He and colleagues have worked to develop a system that could deliver answers within 30 minutes of a blood draw.

He cofounded Inflammatix in 2016 with Purvesh Khatri, the company's chief scientist, and Jonathan Romanowsky, the company's chief business officer. They inked an exclusive license for the testing technology from Stanford and initially aimed to deliver an 18-gene panel to distinguish within one hour whether patients had bacterial, viral, or no infections.

The firm turned heads in 2019 with a disruptive technology award at the American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo. It has since brought in copious funding to finance development and commercialization of its testing system, notably a Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) contract worth up to $72 million in 2019 and a $102 million Series D financing round in 2021.

Sweeney said blood culture is typically a poor tool for identifying infections, and microbiology alone is insufficient for determining which patients have sepsis.

"Most infections don't penetrate the bloodstream," he said. "There's no easy way to target a right lower lobe pneumonia even if you knew that's where the pneumonia is. There's no easy way to culture soft tissues."

TriVerity's results for bacterial and viral infections perform with about 95 percent sensitivity and 95 percent specificity compared to retrospective evaluation through physician adjudication, he said.

As for the test's severe disease risk measurement, researchers from the University of Florida, University of Washington, and Inflammatix coauthored a JAMA Network Open article published last year on a study that evaluated use of an earlier version of TriVerity on samples from 200 patients with suspected sepsis or critical illness with elevated risk of subsequent infection. The authors evaluated in part the use of that test's disease severity scores to predict 30-day mortality and found it performed with area under the receiver operating characteristics curve of .81 compared to an AUROC of .76 for maximum 24-hour sequential organ failure assessment (SOFA) scores, .65 for procalcitonin levels, and .57 for interleukin 6 levels.

In August, researchers connected with Erasmus University Medical Center in Rotterdam, Netherlands, published in the Journal of Clinical Medicine results of a prospective study that used a previous version of TriVerity on samples from 53 COVID-19 patients who received mechanical ventilation and found the 18 patients who died had significantly higher TriVerity risk scores than surviving patients, and the deaths included all four patients who were stratified by the test into the highest risk category for severe illness.

Using five bands of stratifying patients, the authors wrote that the test predicted severe disease in patients in the very high, high, and moderate risk bands with 100 percent, 94 percent, and 74 percent specificity, respectively. The test was also able to rule out severe illness among patients in the low and very low bands with 56 percent and 100 percent sensitivity, respectively.

The sepsis testing market has seen a flurry of activity this past year from both newcomers and diagnostic industry stalwarts.

Immunexpress began commercialization early this year of its FDA-cleared SeptiCyte Rapid qPCR assay for 60-minute determination of the likelihood a patient has sepsis, while DiaSorin said in June it gained CE marking for its Liaison BRAHMS MR-proADM immunoassay to aid diagnosis of conditions including sepsis and stratify patients by disease severity and the risk of unfavorable outcomes.

In addition, Cytovale in August launched its IntelliSep 10-minute sepsis risk-scoring test for use in emergency departments to stratify patients by sepsis risk, and EDX Medical said in October it was combining technologies from recent acquisitions to develop a 15-minute prognostic assay to help identify patients at risk of developing sepsis.

More recently, Oxford Nanopore and Day Zero Diagnostics said this month they are collaborating on an end-to-end diagnostic system for same-day identification and antimicrobial susceptibility profiling of bloodstream infections, while Ad Astra Diagnostics said days later that it had gained FDA 510(k) clearance for its QScout RLD point-of-care hematology analyzer, which is capable of differentiating sepsis faster than lactate and procalcitonin. Finally, Siemens Healthineers announced last week it secured a $5.5 million contract with the National Institute of Allergy and Infectious Diseases to develop a next-generation sequencing-based test that could within six hours of a blood draw identify bacterial and fungal infections and provide details on likely resistance to antimicrobials.

Sweeney, who is a former surgeon, said he always wanted during his time in practice test results that could indicate both whether a patient has an infection and the severity of their illness. He also thinks the TriVerity test could complement existing electronic health record-based algorithms that warn physicians about patients at high risk of sepsis as well as provide evidence to support healthcare decisions in later reviews of sepsis cases.

For now, the company continues gathering evidence to support regulatory review and adoption of the test in hospitals. Inflammatix has enrolled about 1,000 of the 1,500 patients for its Sepsis-Shield study that will analyze gene expression and other laboratory data derived from samples of patients with suspected sepsis or other infections.

"A lot of the focus over the next year is about enrolling and publishing the evidence of accuracy of the test and then beginning to focus on enrolling and publishing the evidence of improved patient outcomes when the test is actually implemented," Sweeney said. "And we're working with some great partners and beginning to design those next bases of evidence, which should begin to enroll next year in terms of the health outcomes and health system outcomes."

Inflammatix is working with payors and hospitals ahead of the commercial launch, he said. The company said in its announcement this week that the FDA breakthrough device designation also makes TriVerity eligible for participation in the US Centers for Medicare and Medicaid Services New Technology Add-on Payment program that could reduce the cost to hospitals of adopting TriVerity for up to three years, and the firm also could secure Medicare coverage for up to four years if the CMS finalizes its proposed Transitional Coverage for Emerging Technologies rule.

Though Inflammatix is focused for now on the US market, the company is also exploring international distribution deals for TriVerity and other tests as well as licensing agreements that could let other companies use the Myrna instrument to identify RNA signatures at the point of care.

"Of course, it's on our roadmap that this should be a test with global implications," he said.