Mesa Receives FDA EUA for 30 Minute POC Molecular COVID-19 Test

Mesa Biotech (San Diego, CA, USA) has received Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) for its Accula SARS-CoV-2 Test, which gives COVID-19 diagnostic results in 30 minutes. Mesa has also 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.

Mesa, a privately-held, molecular diagnostic company, designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid polymerase chain reaction (PCR) amplification to the POC. Last week, the company had received funding from the US Health and Human Services for the development of its SARS-CoV-2 test. Mesa’s Accula SARS-CoV-2 Test is a visually read test using PCR technology to detect SARS-CoV-2, the virus responsible for COVID-19, via throat and nasal swab samples. Similar to Mesa’s commercially available tests for influenza and RSV, the Accula SARS-CoV-2 Test is designed for the POC use, including temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.


"Mesa is excited to immediately begin shipping our rapid, molecular SARS-CoV-2 test so people can get answers in 30 minutes. Our Accula system is easy to use and fits in the palm of your hand. This allows many units to be run side by side in the doctor's office further increasing the speed of COVID-19 diagnosis. Accula provides a true decentralized testing solution for COVID-19 at the point of care," said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. "Our test will provide a highly accessible means for healthcare professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat or dismiss potential carriers of the virus. The potential to reduce the growing strain on our nation's hospitals is tremendous."

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