US FDA approves point-of-care test for coronavirus

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The US Food and Drug Administration on Saturday approved a coronavirus diagnostic test that can be conducted entirely at the point-of-care and can deliver results in 45 minutes. The approval of such a diagnostics test developed by California-based Cephid would help in the fast identification of infected people and quickly start treating them and their quarantine. The test will begin shipping next week.

"The test we're authorising today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort," Health and Human Services Secretary Alex Azar said.

Cepheid said the test has been designed to operate on any of its more than 23,000 automated GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes.

"During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for realtime management of patients being evaluated for admission to healthcare facilities.

"An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources," said Dr David Persing, Chief Medical and Technology Officer at Cepheid.

Cepheid currently has nearly 5,000 GeneXpert® Systems in the US capable of point-of-care testing and for use in hospitals, said Cepheid President Warren Kocmond.

"Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today," he said.

FDA Commissioner Stephen Hann said this marks an important step in expanding the availability of testing and rapid results.

"Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centres and emergency rooms, instead of samples being sent to a laboratory. With today's authorisation, there is now an option for testing at the point-of-care, which enables patient access to more immediate results," he said. 

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