
FDA: Know Your Coronavirus Status In 45 minutes.

Food and Drug Administration (FDA) has approved the first diagnostic test for coronavirus that can be done completely at the point of care.

The test from California-based Cepheid will deliver results in about 45 minutes — much faster than current tests that require a sample to be sent to a centralized lab, where results can take days.

The test has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for conditions such as HIV and tuberculosis.


The systems do not require users to have specialty training to perform testing and are capable of running around the clock.

“An accurate test administered near the patient can be revolutionary” and “help alleviate the pressure” that the COVID-19 epidemic has put on health facilities, David Persing, chief medical and technology officer of Cepheid, said in a statement.

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“Usually, people are frustrated about the turnaround time. They’re not aware about their status until days later. Understanding the status immediately… would allow for better decision-making” and help physicians select the best care, Persing said in a video on the website of the organization as reported by theHILL


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FDA: Know Your Coronavirus Status In 45 minutes

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TheHill


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