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Sepsis
Nonprofit health system adopts Immunexpress test for detecting sepsis
FirstHealth of the Carolinas, a nonprofit health system licensed for four hospitals in North Carolina, will use Immunexpress’ SeptiCyte Rapid test to help differentiate sepsis-positive cases from patients with infection-negative systemic inflammation.
August 23, 2023
Prenosis nabs $749K federal contract to study clinical utility of AI-based diagnostic tool for sepsis
The firm’s Sepsis ImmunoScore is a pathogen-agnostic, host-based digital diagnostic tool that uses artificial intelligence/machine learning to predict sepsis using clinical parameters and protein biomarkers.
June 7, 2023
T2 Biosystems seeking FDA breakthrough device designation for Candida auris test
The Lexington, MA-based maker of a molecular platform and tests for sepsis and other bloodstream infections recently announced plans to add Candida auris detection to its FDA-cleared T2Candida Panel.
June 6, 2023
Asep Medical Holdings aims for Nasdaq listing
Sepset Biosciences, an Asep Medical business, is preparing for clinical studies aimed at the commercialization of a diagnostic test. The test leverages gene expression to predict the development of severe sepsis.
May 31, 2023
Validation data presented for Cytovale sepsis diagnostic test
The lead investigator has presented the results of a study to validate a rapid diagnostic test that detects sepsis in the emergency department. The study data were used to obtain FDA clearance for the test last December.
May 24, 2023
T2 Biosystems submits FDA 510(k) premarket notification for biothreat panel
The panel is a fully-automated, direct-from-blood test designed to run on the T2 Biosystem’s FDA-cleared T2Dx Instrument and simultaneously detects six pathogens identified as threats by the CDC.
May 23, 2023
Immunexpress to present data on host-response sepsis test at ECCMID 2023
The firm's SeptiCyte Rapid molecular test for sepsis uses reverse transcription polymerase chain reaction to quantify the relative expression levels of host-response genes isolated from whole blood.
April 5, 2023
Ad Astra Diagnostics files FDA 510(k) application for point-of-care hematology analyzer
The QScout hematology platform is a rapid testing system that would operate at the point of care to provide measurements indicative of disease and infection, including sepsis.
March 30, 2023
Sepsis increases heart failure, rehospitalization risks following hospital discharge
Hospital patients who initially had or developed sepsis were at higher risk for heart failure, rehospitalization, or death within 12 years than patients without sepsis.
February 1, 2023
Vision Research supplies high-speed camera for Cytovale point-of-care sepsis test
An enabling technology for flow cytometry, the Vision Research Phantom VEO 710 high-speed camera resolves blood cells as they move through a microfluidics channel at three meters per second.
January 30, 2023
Asep Medical inks joint venture term sheet with Sansure Biotech, preps sepsis test for launch in China
As part of the agreement, Sansure will invest in the joint venture. Asep Medical will provide a sublicense to patent rights to its Sepset sepsis test for the Chinese marketplace and would receive a royalty when the test is marketed.
January 30, 2023
T2 Biosystems nabs contract extension with group purchasing organization
Products covered under the contract with Vizient, a purchasing organization for healthcare institutions, include the T2Dx Instrument, T2Bacteria Panel, and T2Candida Panel. All detect sepsis-causing bacterial and fungal pathogens from whole blood.
December 28, 2022
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