The only FDA authorized palm-sized system for COVID-19 testing enables broader use across healthcare facilities and closer to the patients with rapid results
SAN DIEGO, CA – April 7, 2020 – Today, Mesa Biotech announced it is shipping 10,000 of its Accula™ SARS-CoV-2 molecular rapid point of care (POC) tests this week. The company’s COVID-19 test uses patented technology to enable ‘near patient’ testing outside of the central laboratory with diagnostic results in 30 minutes. Mesa Biotech Inc., a San Diego based, molecular diagnostic company, has developed an affordable, easy to use, palm-sized molecular testing platform designed for rapid near patient infectious disease diagnosis.
“We will ship 10,000 tests this week and continue executing on our capacity expansion initiatives,” said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. “I am so proud of everyone in our company for their unwavering dedication during unprecedented circumstances to help meet the critical need for rapid near patient COVID-19 testing.”
The Accula System provides a true decentralized testing solution for COVID-19 at the point of care. The Accula SARS-CoV-2 is easy to use, fits in the palm of your hand and provides a highly accessible means for healthcare professionals to access laboratory quality results near the patient. With diagnostic results in 30 minutes, physicians can decide to isolate, treat or dismiss potential carriers of the virus.
The Accula SARS-CoV-2 Test is a visually read test using reverse transcription polymerase chain reaction (RT-PCR) technology to detect SARS-CoV-2 (the virus responsible for COVID-19) via throat and nasal swab samples. Similar to Mesa Biotech’s commercially available tests for influenza and RSV, the Accula SARS-CoV-2 Test is designed for point-of-care use, including temporary screening facilities, physician office labs, urgent care, and long term nursing facilities. The system complements central laboratories where current testing is performed.
Mesa Biotech’s technology was developed at Los Alamos National Lab supported by NIH grants from the National Institute of Allergy and Infectious Diseases (NIAID) and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program. In mid-March, the company received funding from the U.S. Health and Human Services for development of its SARS-CoV-2 test and less than one week later received emergency use authorization. Since its inception, the company has focused on technology well-suited for emergency defense and rapid deployment for SARS, Ebola and other emerging infectious diseases. Mesa Biotech’s platform was specifically designed for use outside the lab to enable rapid responses to global pandemics, such as COVID-19.About Mesa Biotech Inc.Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care. Mesa Biotech’s Accula™Flu A/Flu B and RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). Both products are distributed in the United States by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia.