Molecular diagnostic test provider Mesa Biotech announced on Tuesday the receipt of US Food & Drug Administration (FDA) Emergency Use Authorization (EUA) for its Accula SARS-CoV-2 Test that provides the COVID-19 diagnostic results in 30 minutes.
According to the company, it has developed an affordable, easy to use testing platform designed for point-of-care (POC) infectious disease diagnosis. The COVID-19 test uses this patented technology to enable 'near patient' testing allowing testing outside of the central laboratory.
The company said Accula SARS-CoV-2 Test is a visually read test using polymerase chain reaction (PCR) technology to detect SARS-CoV-2 (the virus responsible for COVID-19) via throat and nasal swab samples. The test is designed for the point-of-care use, temporary screening facilities, physician office labs, urgent care and long term nursing facilities and complements the tests performed in central laboratories.
Mesa Biotech added that its technology was developed at Los Alamos National Lab supported by NIH grants from the National Institute of Allergy and Infectious Diseases and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program.
Last week, the company received funding from the US Health and Human Services for development of its SARS-CoV-2 test.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval