Inflammatix has concluded the technical development for its TriVerity Acute Infection and Sepsis Test System, which comprises the Myrna instrument and the TriVerity cartridge.
TriVerity is designed for use in emergency department settings to evaluate the likelihood of a viral infection, bacterial infection and the acute decompensation risk in patients with suspected acute infection and sepsis.
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The Myrna instrument is intended for sample-to-answer quantitation of up to 64 messenger RNAs (mRNAs) from whole blood or other types of samples in roughly half an hour.
For enabling point-of-care deployments, this instrument is designed to meet the requirements for a Clinical Laboratory Improvement Amendments (CLIA) waiver.
The disposable cartridges are anticipated to be stable at room temperature for up to 12 months.
Inflammatix CEO and co-founder Dr 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.
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By GlobalData“Completing technical development brings TriVerity a step closer to FDA submission and launch and enables us to execute key clinical studies.”
The TriVerity test incorporates a panel of 29 mRNAs for reading the immune response of the body, thereby enabling the diagnosis of suspected acute infection and sepsis patients.
It is intended to potentially assist in diagnosing patients with suspected infections that are present in US emergency departments.
The company has resumed the completion of its studies, including its SEPSIS-SHIELD multi-centre study, which is essential for submitting the TriVerity Test system to the US Food and Drug Administration (FDA).
The study has enrolled 955 out of the required 1,500 patients. Inflammatix expects to complete the study and submit it to the FDA by next year.
