FDA issues emergency approval for faster, on-site coronavirus tests

Faster coronavirus tests are on the way.

The diagnostics company Cepheid has received emergency federal approval for the use of its tests — which can detect the virus causing COVID-19 in just 45 minutes, the US Food and Drug Administration announced Saturday.

The tests can be administered on-site at a hospital or doctor’s office while the worried patient waits, and without needing to be sent to a separate lab.

Currently, coronavirus testing typically takes several days, with samples sent to central labs for analyses.

It is the first so-called “point-of-care” test approved by the FDA, with Cepheid planning to make the tech available starting Monday, March 30.

“We are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” HHS Secretary Alex Azar said in a statement.

Health experts have said faster and expanded testing can help reduce the spread of the virus by ensuring those sickened are informed of their diagnoses and take proper quarantine measures.

The tests do require a specific machine called the GeneXpert, Cepheid told CNBC. There are currently more than 23,000 GeneXpert systems around the world, including almost 5,000 in the U.S., the company said.

“Today marks an important step in expanding the availability of testing and, importantly, rapid results,” said FDA Commissioner Stephen Hahn in a statement to the outlet.

“Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms,” he added, “instead of samples being sent to a laboratory.”

Source: Read Full Article