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Inflammatix Gets FDA Clearance for 30-Minute Sepsis Test, Preps for US Launch

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NEW YORK – Inflammatix is poised to bring to market its 30-minute sepsis test to help identify patients with infectious and noninfectious disease as well as predict which of those patients will need ICU-level care.

The Sunnyvale, California-based firm earlier this month gained US Food and Drug Administration 510(k) clearance for its TriVerity Test System, a blood-based reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay that is used to determine the relative expression levels of host response genes to aid the assessment of patients with suspected sepsis. It delivers three scores, two of which are used to differentiate bacterial infections, viral infections, and noninfectious disease. A third prognostic score is used to identify the likelihood that a patient will in the following seven days develop severe illness that will require interventions such as mechanical ventilation, vasopressors, or renal replacement therapies.

TriVerity is an automated, semi-quantitative assay designed for use with whole-blood samples. Performed on Inflammatix's cartridge-based sample-to-answer Myrna instrument, the test comprises a panel of 29 mRNA biomarkers and a machine learning-derived algorithm to assess a patient's immune response plus three housekeeping mRNA markers.

Inflammatix Cofounder and CEO Tim Sweeney said in an interview that using TriVerity could help to reduce deaths and unnecessary hospital admissions, as well as the length of hospital stays, patient wait times in emergency rooms, and healthcare costs. Additionally, it can aid clinicians to identify a disease by infection type, allowing them to determine the likelihood that their patients' illnesses will progress to severe disease.

Meanwhile, the company continues to gather evidence of TriVerity's clinical utility and expects to soon produce its first outcomes data. The company announced in November that it had begun its TriVerity for Improved Management of Emergency Department Patients (TIMED) trial to demonstrate the effects of TriVerity on patient management. For the study, it plans to enroll 600 patients accessing care from the emergency departments of Johns Hopkins University Medical Center in Baltimore and OSF Healthcare Saint Francis Medical Center in Peoria, Illinois.

The trial will be used to measure the effects of using the test on compliance with the US Centers for Medicare and Medicaid Services' Severe Sepsis and Septic Shock Management (SEP-1) Bundle and the time to emergency department admission or discharge. It will also be used to measure the effects on appropriate use of antibiotic and antiviral drugs, length of stay in the emergency department, the ordering of other tests, hospital admission rates, and total hospital costs. Sweeney noted that Inflammatix is working with other healthcare facilities to establish additional pilot studies that can show the health economic outcomes of TriVerity testing.

Differentiating noninfectious and high-risk diseases

The company's prior trials had focused on the use of the test when it's uncertain whether a patient has sepsis, Sweeney said, and when it was uncertain whether that patient should be admitted.

Patients without sepsis may still have acute infections or severe underlying problems that require ICU-level care, and TriVerity was designed to help determine both why a patient is presenting in the emergency department and whether they are likely to need ICU-level care. Sweeney said that while other tests have been designed for more narrow assessments of whether a patient has sepsis, TriVerity's results can provide information that clinicians can use to determine the level of care needed.

"What you really want is a test that is viewed as routinely useful, and I think that's the typical problem with most sepsis tests," he said.

In preparation of a commercial launch of TriVerity, Inflammatix has several ongoing trials to demonstrate the test's utility.

In September 2024, Inflammatix completed a clinical trial on the use of the TriVerity test with so-called "gray zone" patients by using it to assess a broad population of adults who presented to the emergency department with one abnormal vital sign and a suspected acute infection or two abnormal vital signs and suspected sepsis, Sweeney said.

Meanwhile, the firm's Sepsis-SHIELD trial, begun in February 2020 and completed in September 2024, was a prospective multicenter clinical study that was used to assess the performance of TriVerity with the Myrna instrument using samples from 1,222 patients.

"What we want is to provide the maximum benefit to physicians and to patients in terms of actually being able to, hopefully, help make these decisions confidently and in the right way," Sweeney said.

He said that the test performed with high accuracy for the diagnosis of bacterial or viral infections, the differentiation of infections and noninfectious disease, and the prediction of the need for ICU-level care in the following seven days. He also noted that the test outperformed existing biomarkers such as procalcitonin, C-reactive protein, and white blood cell count in head-to-head comparisons.

The researchers evaluated the performance of the bacterial and viral test results with scores split among interpretation bands, which range from very low to very high likelihood of infection, and Sweeney said that it performed with high sensitivity at the low ends of the score and high specificity at the high end of the score. Those results allow high rule-in or rule-out likelihoods for patients at the ends of the score ranges and lower confidence for patients in the mid-range.

The company reported that the test achieved an overall area under the receiver-operator characteristic curve (AUROC) of 0.83 for bacterial testing, 0.91 for viral testing, and 0.78 for illness severity prognostic testing when compared to consensus adjudication. Sweeney noted that the bacterial, viral, and severity scores in the "very low" risk category had sensitivities of 97 percent, 95 percent, and 92 percent, respectively, while the "very high" risk bands had specificities of 95 percent, 98 percent, and 99 percent, respectively.

For now, the test is available only for use with adult patients, although Sweeney said that better diagnostic testing is needed in children, and Inflammatix plans to gather data that would allow label expansion for pediatric patients.

Inflammatix is also considering potential applications of its technology in other areas of the hospital where it would be beneficial to determine whether patients have infections and how sick they are, although Sweeney said that the company sees the greatest need in emergency departments.

Commercialization in a crowded space

Inflammatix was cofounded in 2016 as a Stanford University spinout, and the work to develop the TriVerity test began with a project to understand critical illness through mRNA profiling.

As of September 2024, the company had raised more than $200 million in private capital including $57 million in Series E financing to support regulatory filings and the commercialization of TriVerity.

Because the test had secured in 2023 breakthrough device designation from the FDA, the now-cleared test is eligible for a US Centers for Medicare and Medicaid Services new technology add-on payment (NTAP), Sweeney said. He expects that will become active starting Oct. 1. The firm also intends to work with CMS through the crosswalk process, which is used to determine the price of a new code by comparing it to existing codes on the market and assigning the same payment.

Because Inflammatix is entering an increasingly crowded space with competitors making similar claims, Robert Boorstein, founder and director of the laboratory consulting firm ClasGroup, said that the company will need to show that its test is cost-effective. Additionally, its tests need to be easy enough to perform that clinical personnel can be trained to run it 24 hours in an emergency department.

Boorstein added that Inflammatix will need to demonstrate that the use of the test improves outcomes. In the absence of such data, it will be harder for the TriVerity test to stand out from the crowd.

In that vein, in December, Chicago-based Prenosis said it was preparing for the clinical implementation of its AI-developed Sepsis ImmunoScore software to predict which patients are at risk of developing sepsis while MeMed gained FDA breakthrough device designation for its MeMed Severity test to manage patients suspected of acute infections or sepsis. Cytovale, meanwhile, is expanding the commercialization of its IntelliSep prognostic test for patient risk stratification, and Immunexpress offers its SeptiCyte Rapid test to assess patients with suspected sepsis and generate rule-in, rule-out results for the probability of sepsis.

According to Sweeney, though, the TriVerity test is differentiated from competitors because it is used to aid the identification of infections and the likelihood of critical illness rather than defining whether a patient has sepsis syndrome. He added that the test is easy to perform by a trained technician, requiring about 30 seconds to run a sample.

Sweeney said that Inflammatix is focused in the near term on demonstrating that TriVerity's results can change patient outcomes in hospital emergency departments. In the longer term, he said that the company intends to develop other host response-based tests that could be used to aid decisions on immunotherapies in critically ill patients or improving the diagnosis of heart attacks in an emergency department setting.

He said that Inflammatix expects results from the TIMED study on patient outcomes in the first half of the year, with the data to be submitted to a peer-reviewed publication. Meanwhile, the company is building its direct sales force to support the launch of the test in partnerships with hospitals, especially those that partnered with Inflammatix on the Sepsis-SHIELD study and other studies.