‘Emergency Use’ Coronavirus Test With Capacity Ot Deliver Results 45 Mins Allowed By FDA

The rapid molecular test for point-of-care patients developed by Cepheid has been authorized by the United States Food and Drug Administration (FDA) on an emergency basis and now can be used for detecting coronavirus in just 45 minutes

This test is the first of its kind that can be used entirely at the point of care for patients and is able to come out with results in less than an hour.

Typically test swabs of suspected patients that are sent to the central reference labs in the US take several days to get completed before the patient or the doctor can know the results.

The company said that it will begin to ship the tests on Friday, March 27 with hopes that it will reach the markets and be available for use by 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 statement Saturday.

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

Cepheid, a Sunnyvale, California, company, developed the test which is called the SAR-CoV-2 Xpert Xpress and is able to detect the SARS-CoV-2, the virus causes the disease COVID-19.

A full test can be run in 45 minutes in the testing machine developed by Cepheid called GeneXpert. Cepheid said in a statement that there are more than 23,000 automated GeneXpert systems globally while almost 5,000 of such systems currently available in the US.

Cepheid uses a very similar technology for flu tests.

“During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care 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 health-care facilities that need to properly allocate their respiratory isolation resources,” Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid said in a statement.

Its automated systems “do not require users to have specialty training” to perform the tests, said Cepheid President Warren Kocmond.

(Adapted from CNBC.com)

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