Research & Development
Ethos Laboratories awarded US FDA's EUA for SARS-CoV-2 MALDI-TOF Assay
11 August 2020 -

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.

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