Wednesday 27 / November / 2024
US regulators approved a fast coronavirus test on Saturday, in time to supply a nation that has struggled to meet test demand as the COVID-19 pandemic ramps up.
The test has a detection time of 45 minutes and was developed by California-based molecular diagnostics company Cepheid.
It gained approval from the US Food and Drug Administration (FDA) through emergency authorization and plans to begin shipping tests next week.
The tests will be primarily distributed at hospitals and emergency rooms.
"With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them," US Secretary of Health and Human Services Alex Azar said.
Azar added the tests would provide "results within hours, rather than days like the existing tests."
Testing shortage
Testing speed and availability are seen as a key part of efforts to limit the spread of the new coronavirus.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said when it came to meeting testing demands, the United States was "not there yet."
Many medical experts have predicted that delayed and chaotic testing could cost lives, including those of doctors and nurses.
The new 45-minute test could help change the situation. Currently, when tests are administered, samples must be sent to a centralized lab and getting results back can take days.
Cepheid's diagnostic test has been designed to operate on any of its more than 23,000 automated GeneXpert Systems globally, the company said.
These systems do not require users to have special training to operate and are capable of running around the clock, Cepheid President Warren Kocmond said in the statement.
"Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory," FDA Commissioner Stephen Hahn said.
More than 19,000 COVID-19 infections have been confirmed in the US, with over 270 deaths. Some tens of millions of people are under lockdown measures in order to help curb the spread of the virus.
