Clinical diagnostic laboratory Ethos Laboratories Emergency Use Authorization (EUA) reported on Monday the receipt of US Food and Drug Administration (FDA) Emergency Use Authorization for SARS-CoV-2 MALDI-TOF Assay to rapidly process a large number of samples without the reagent constraints facing other laboratories.
The company added that the SARS-CoV-2 MALDI-TOF Assay is a high-throughput molecular SARS-CoV-2 panel that tests for the novel coronavirus that causes COVID-19. The matrix-assisted laser desorption ionization–time of flight mass spectrometry in this authorization allows to process a sample in 12 hours. The majority of samples are processed and results are released within one business day of receipt.
In conjunction, the wide availability of the company said its testing and the one-day turnaround will benefit public health, travel industry, health providers, businesses, as well as for upcoming school re-openings to ensure a safe learning environment for faculty and students.
Additionally, the company is working with local community leaders and health care providers to ensure access to this FDA-authorized testing in Newport, Kentucky and select pop-up locations. It is the first laboratory in the US to receive EUA for the technology and workflow.
Cereno Scientific's Phase IIb trial of CS1 in PAH approved by US FDA
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Mirum Pharmaceuticals to acquire Bluejay Therapeutics for HDV treatment
PureTech clears key FDA milestone for Phase 3 development of deupirfenidone
J & D Pharmaceuticals' investigational therapy for HCC receives US FDA Orphan Drug Designation
FDA lifts partial clinical hold on Vanda Pharmaceuticals' tradipitant for motion sickness
TransThera publishes clinical results from US-based Phase 2 trial of tinengotinib in CCA
Hope Medicine wins FDA Fast Track Designation for HMI-115 in endometriosis
MED-EL cochlear implant FDA approved for children 7 months and older