The TriVerity acute infection and sepsis test system comprises the Myrna Instrument and the TriVerity Cartridge, to assess the likelihood of bacterial infection, a viral infection, and the risk of acute decompensation, in patients with suspected acute infection and sepsis
TriVerity Acute Infection and Sepsis Test System. (Credit: Inflammatix)
US-based molecular diagnostics company Inflammatix announced the completion of technical development for its lead product TriVerity Acute Infection and Sepsis Test System.
The system is intended to be used in emergency department settings and comprises the Myrna Instrument and the TriVerity Cartridge.
It is designed to assess the likelihood of a patient acquiring bacterial infection, a viral infection, and the risk of acute decompensation, in patients with suspected acute infection and sepsis.
Myrna Instrument is capable of sample-to-answer quantitation of up to 64 messenger RNAs (mRNAs) from whole blood or other sample types, within 30 minutes.
It is designed to facilitate point-of-care deployments, waived under the Clinical Laboratory Improvement Amendments (CLIA).
The TriVerity disposable cartridges are expected to be stable at room temperature for up to 12 months.
Inflammatix CEO and co-founder Timothy Sweeney said: “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.
“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.
“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.”
TriVerity Acute Infection and Sepsis Test incorporates a panel of 29 mRNAs to read the body’s immune response and help identify patients with suspected acute infection and sepsis.
It is designed to potentially facilitate the diagnosis of patients with suspected infections that present in US emergency departments.
Inflammatix has resumed its clinical studies, including the SEPSIS-SHIELD study of the TriVerity Test system, required for the US Food and Drug Administration (FDA) submission.
The study has already enrolled 955 of the expected 1,500 patients, with plans to complete the study and FDA submission by spring 2024.
Furthermore, Inflammatix is partly funded by Federal funds from the Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA).