Mesa Biotech gains emergency FDA approval for rapid, point-of-care COVID-19 test
The U.S. Food and Drug Administration (FDA) is making use of its Emergency Use Authorization (EUA) powers to expand the pool of available COVID-19 testing resources in the U.S., and now you can add another rapid test that delivers results in just 30 minutes to the list. Mesa’s test is also small enough to be able to be used right at the frontline of care, including in clinics and hospitals, with multiple tests able to be run in parallel.
Mesa’s rapid test follows one from Cepheid that was approved on Monday. Both are PCR-based molecular tests, which identify the presence of virus DNA in a sample of a patient’s mucus. Both these tests prevent an important expansion of the technologies available to those looking to combat the spread of the new coronavirus, since they can provide lab-quality results, but can do so much faster and without requiring transportation of the samples from the point of collection to off-site testing facilities.
On-site testing not only has advantages in terms of convenience and speedy return of results, but also in limiting the potential exposure of medical personnel to the virus itself. Testing on-site means you don’t need to worry about possible exposure to the virus for more people in the chain, including logistics and delivery people, as well as lab technicians and dedicated diagnostics people.
These tests will require that facilities are equipped with Mesa’s Accula testing system, but its equipment is already in use for testing flu, as well as other less serious equipment, and it was originally designed specifically to address use on the frontlines of efforts to combat global pandemics, including SARS before this.