We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
BIO-RAD LABORATORIES

Download Mobile App




Events

15 Apr 2024 - 17 Apr 2024
23 Apr 2024 - 26 Apr 2024
25 Apr 2024 - 27 Apr 2024

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

By LabMedica International staff writers
Posted on 20 Nov 2023
Print article
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."

Related Links:
Inflammatix, Inc.

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Magnetic Bead Separation Modules
MAG and HEATMAG
Anti-Cyclic Citrullinated Peptide Test
GPP-100 Anti-CCP Kit
New
Gold Member
TORCH Panel Rapid Test
Rapid TORCH Panel Test

Print article

Channels

Clinical Chemistry

view channel
Image: The 3D printed miniature ionizer is a key component of a mass spectrometer (Photo courtesy of MIT)

3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models

Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels... Read more

Molecular Diagnostics

view channel
Image: AI analysis of DNA fragmentomes and protein biomarkers noninvasively detects ovarian cancer (Photo courtesy of Adobe Stock)

Blood-Based Machine Learning Assay Noninvasively Detects Ovarian Cancer

Ovarian cancer is one of the most common causes of cancer deaths among women and has a five-year survival rate of around 50%. The disease is particularly lethal because it often doesn't cause symptoms... Read more

Hematology

view channel
Image: The CAPILLARYS 3 DBS devices have received U.S. FDA 510(k) clearance (Photo courtesy of Sebia)

Next Generation Instrument Screens for Hemoglobin Disorders in Newborns

Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more

Immunology

view channel
Image: The groundbreaking treatment approach has shown promise in hard-to-treat cancers (Photo courtesy of 123RF)

Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment

Cancer treatment typically adheres to a standard of care—established, statistically validated regimens that are effective for the majority of patients. However, the disease’s inherent variability means... Read more

Pathology

view channel
Image: ‘Virtual biopsy’ allows clinicians to analyze skin noninvasively (Photo courtesy of Stanford Medicine)

Virtual Skin Biopsy Determines Presence of Cancerous Cells

When dermatologists spot an unusual mark on a patient's skin, they face a choice: monitor it for some time or remove it for biopsy. Similarly, when removing breast tumors, surgeons must send excised tissues... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.