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Malaria rapid tests in study show low performance for travelers to China
The study evaluated the sensitivity of four parasite enzyme lactate dehydrogenase-targeting RDTs and one aldolase-targeting RDT for P. malariae detection.
May 25, 2023
Eurobio Scientific obtains IVDR CE markings for PCR tests
The CE markings enable the firm to market three of its PCR tests as class C in vitro diagnostic medical devices for the detection of infectious diseases.
May 24, 2023
FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults
Paxlovid is the fourth drug — and first antiviral pill — approved by the FDA to treat COVID-19 in adults.
May 25, 2023
Renalytix selects Eversana to expand commercialization of KidneyIntelX test for diabetic kidney disease
The commercialization model developed by the two companies will be launched to primary care providers in parts of the U.S. later in the summer.
May 25, 2023
Illumina CEO remains on the board, chairman is voted out
Activist investor Carl Icahn, in a proxy fight, had urged the shareholders to remove the chairman and CEO from the board.
May 26, 2023
NIH-backed project develops scoring system for identifying long-COVID patients
While multiple earlier studies have assessed the effects of long COVID, previous efforts largely had retrospective designs, relied on electronic health record entries, and lacked an uninfected comparison group.
May 25, 2023
Domus Diagnostics gets $2.4M NIH grant to develop at-home molecular test
The award, granted as part of the NIH Rapid Acceleration of Diagnostics (RADx) Tech program, will support accelerated validation and scaling of a testing platform to prepare it for a clinical trial.
May 24, 2023
BPGbio expands agreement with DoD on AI-guided breast cancer diagnostic panel
The diagnostic panel was developed using artificial intelligence to identify patients diagnosed with ER+ breast cancer who do not respond to hormone therapy, to guide caregivers to appropriate treatment options.
May 24, 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
Medical records link vaccination against COVID-19 to reduced risk of non-respiratory symptoms
An analysis, details of which were presented Tuesday at the ATS 2023 International Conference in Washington, DC, reviewed data from 63,454 patients who were treated in a University of California medical center for COVID-19.
May 23, 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
Antibody titer levels associated with protection against Omicron: Study
Immunoglobin G and neutralizing antibody titer levels were associated with protection against infection with the Omicron variant and against symptomatic disease.
May 23, 2023
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