Mesa Biotech gets emergency FDA approval for rapid COVID-19 testing
SAN DIEGO (KUSI) – A San Diego molecular diagnostic company announced Tuesday that it has received fast-track emergency approval from the U.S. Food and Drug Administration for its COVID-19 diagnostic test, which the company says can provide results within 30 minutes.
Mesa Biotech Inc. says its Accula SARS-CoV-2 test utilizes throat and nasal samples to detect SARS-CoV-2, the virus that causes COVID-19.
The FDA’s emergency authorizations fast-track unapproved medical products for use during a public health emergency.
“Mesa is excited to immediately begin shipping our rapid, molecular SARS-CoV-2 test so people can get answers in 30 minutes,” said Hong Cai, Mesa Biotech co-founder and CEO. “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.”
Mesa said the test is designed for use in temporary screening facilities, physician office labs, urgent care and long-term nursing facilities.
Other regional companies that have recently received emergency approval from the FDA to supply COVID-19 detection tests include Hologic Inc. and Quidel Corp. in San Diego, and Thermo Fisher Scientific Inc. and GenMark in Carlsbad.
Laura Dullanty, Sr. Manager, Marketing & Commercial Services, Mesa Biotech, Inc., spoke to KUSI via telephone to tell us more about it.