Ethos Laboratories Receives FDA Emergency Use Authorization for SARS-CoV-2 MALDI-TOF Assay

NEWPORT, Ky., Aug. 10, 2020 /PRNewswire/ -- Ethos Laboratories announced today that the company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SARS-CoV-2 MALDI-TOF Assay. 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. Ethos is the first laboratory in the nation to receive EUA for this technology and workflow. The matrix-assisted laser desorption ionization–time of flight mass spectrometry or (MALDI-TOF MS) in this authorization allows Ethos to process a sample in 12 hours. The majority of samples are processed and results are released within one business day of receipt at the lab.

The wide availability of this testing and the one-day turnaround will greatly benefit the following:

• Public Health, with contact tracing efforts to help limit the spread of infection in communities
• The travel industry, where carriers, hospitality organizations, and state and county governments require travelers to have recent negative COVID-19 tests in order to safely conduct business and personal travel
• Health providers, who need patients to provide current COVID-19 status in order to perform needed procedures safely
• Businesses, which need reliable, available testing with prompt results in order to initiate safe return-to-work programs for their offices
• Back to school preparation and ongoing surveillance to ensure a safe learning environment for faculty and students

Ethos is working with local community leaders and health care providers to ensure access to this FDA-authorized testing.

"Accurate testing with prompt reporting is critical. We are excited to be able to provide this service to the country," said Todd Bladel, COO of Ethos Laboratories. "Rapid reporting is fundamental for people to take appropriate action and limit the spread of infection."

"We evaluated several different technologies to best meet the demands of this pandemic. Ethos' FDA-authorized test uses technology that limits supply chain issues related to reagents while still providing high throughput and fast turnaround time," said Joshua Gunn, CSO of Ethos Research and Development.

This testing is currently available at Ethos Laboratories in Newport, Kentucky and select pop-up locations. To schedule a test please visit www.ethos-labs.com

About
Ethos Laboratories is a clinical diagnostic laboratory located in Newport, Kentucky, dedicated to improving the lives of patients suffering with pain, providing personalized diagnostic services through cutting-edge testing and continuous innovation. Turn-around is among the fastest in the industry, presenting novel levels of transparency, honesty, excellence, and integrity in the laboratory industry. The company focuses on providing excellent quality, service, and support for every customer, and the highest standards for accuracy and efficiency. The laboratory has created innovative tools, resources, and processes that have improved provider insight into sources of pain, increased understanding of medication compliance and management, and fuels the pursuit of continuous improvement including launching a telehealth integration platform.

Media Contact for Ethos:

Tim Adams
CFO
+1 (916) 616-2893
[email protected]

https://www.ethos-labs.com/
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SOURCE Ethos Laboratories