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World's Highest-Multiplex POC System with RNA Quantitating Ability Detects Bacterial Infection

By LabMedica International staff writers
Posted on 20 Nov 2023
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Image: The TriVerity Acute Infection and Sepsis Test System (Photo courtesy of Inflammatix)
Image: The TriVerity Acute Infection and Sepsis Test System (Photo courtesy of Inflammatix)

Sepsis and antimicrobial resistance (AMR) are major contributors to increasing deaths and healthcare costs globally. In clinical settings, diagnosing and treating these conditions present significant challenges. Physicians, especially in emergency rooms, often face difficulties in making prompt, accurate decisions regarding antibiotic use for the roughly 15 million patients annually who present with suspected acute infection and sepsis. In response to this challenge, a new test system specifically designed for emergency department use is being developed. This system aims to evaluate the likelihood of bacterial or viral infections and the risk of acute decompensation, which necessitates ICU-level care, in patients with suspected acute infection and sepsis.

Inflammatix, Inc. (Sunnyvale, CA, USA) has completed technical development for its TriVerity Acute Infection and Sepsis Test System. This system includes the Myrna Instrument and the TriVerity Cartridge. The Myrna Instrument is adept at analyzing up to 64 messenger RNAs (mRNAs) from whole blood or other types of samples within approximately 30 minutes. Designed for potential use at the point-of-care, the Myrna Instrument is aimed to meet the criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver. The accompanying disposable cartridges are designed to be stable at room temperature for up to a year.

The TriVerity Acute Infection and Sepsis Test, a leading product from Inflammatix, utilizes a panel of 29 mRNAs to interpret the body's immune response, assisting in the diagnosis of patients with suspected acute infection and sepsis. This test is particularly targeted at diagnosing patients who present with suspected infections in U.S. emergency departments. Inflammatix is actively working on completing its clinical studies, including the SEPSIS-SHIELD study, which is essential for the submission of the TriVerity Test system to the U.S. Food and Drug Administration (FDA). This multi-center study has already enrolled 955 patients out of the anticipated 1,500. Inflammatix anticipates the completion of the study and the subsequent FDA submission by spring 2024.

"Myrna will be the world's highest-multiplex point-of-care system capable of quantitating RNA, allowing us to bring 'precision medicine' into acute care settings," said Dr. Timothy Sweeney, CEO and co-founder of Inflammatix. "Completing technical development brings TriVerity a step closer to FDA submission and launch, and enables us to execute key clinical studies."

"With the completion of the test system, we look forward to further exploring partnerships that bring existing RNA signatures onto the Myrna ecosystem," Dr. Sweeney commented. "This may be an especially viable pathway given expected changes to the regulation of lab-developed tests and the increased reliance on a biomarker-driven approach to immunotherapy development."

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