FDA invokes emergency powers to authorise 30-minute, handheld COVID-19 test
pharmafile | March 27, 2020 | News story | Medical Communications, Sales and Marketing | COVID-19, FDA, Mesa Biotech, US, coronavirus
The FDA invoked Emergency Use Authorization powers to approve a rapid, handheld testing kit for COVID-19 coronavirus cases just days before US cases of the virus swelled to overtake China as the country with the most positive tests in the world.
The US regulator moved to rapidly approve Mesa Biotech’s Accula SARS-CoV-2 Test, which the company claims can diagnose COVID-19 with laboratory-quality results in just 30 minutes.
The technology can run multiple parallel tests and can be used at point-of-care in front-line scenarios including critical care, physician labs and temporary screening facilities – a crucial advantage when it comes to limiting unnecessary exposure of medical professionals to the disease. It utilises polymerase chain reaction (PCR) technology to analyse throat and nasal swab samples to identify the presence of the SARS-CoV-2 virus.
The testing kit was developed with support from the National Institute of Allergy and Infectious Diseases (NIAID) and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program, and recently received a funding injection from the US Department of Health and Human Services as it moved to tackle the COVID-19 crisis.
“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 decentralised testing solution for COVID-19 at the point of care,” commented Hong Cai, Co-founder and Chief Executive Officer at Mesa Biotech. “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.”
Matt Fellows
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
