• Christos Evangelou, PhD

The FDA approves a new rapid coronavirus test

Updated: Nov 3, 2020

The US Food and Drug Administration (FDA) has recently authorized the use of a rapid diagnostic test that can provide results in less than one hour.

(Image by Gerd Altmann from Pixabay)

Delayed testing and inaccurate results can be detrimental in restraining the transmission of viruses during outbreaks. Both of these factors have contributed to the rapid transmission of SARS-CoV-2 worldwide, leading to the global coronavirus disease (COVID-19) crisis.

Therefore, in the last few weeks, regulatory bodies have been providing accelerated approvals of new faster testing tools developed by hospitals and commercial laboratories. The US Food and Drug Administration (FDA) has recently authorized the use of a rapid diagnostic test that can provide results in less than one hour.

Cepheid, a California-based biotechnology company that manufactures the new test, has announced that the distribution of the test will start in the next few days.

"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," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "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." [1]

The development of faster testing has been an urgent need, as the long turnaround in testing can foster the rapid spread of the coronavirus. The turnaround time on testing results using the current methods ranges from 24 hours to four days, during which time an infected person can transmit the SARS-CoV-19 to a significant number of people.

Thus, if COVID-19 cases are not identified quickly and if the appropriate measures preventing community transmission are not in place, the number of confirmed cases will keep increasing exponentially.

In response to the rapid outbreak of the novel coronavirus strain, on February 10, 2020, Cepheid has announced the launch of the development of an automated molecular test for the quantitative detection of SARS-CoV-2.

On March 21, 2020, the company has announced that they received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for their new coronavirus test, which is called Xpert Xpress SARS-CoV-2. According to Cepheid, the test is expected to deliver point-of-care results in approximately 45 minutes.

"By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly," said Dr. Persing.

Xpert Xpress SARS-CoV-2 requires less than a minute of hands-on time to prepare the samples and can provide actionable test results, allowing for rapid, informed treatment decisions to be made. Importantly, in contrast to current tests, this new test can deliver point-of-care results, meaning that the patient samples don't need to be sent to a separate lab to be processed while providing the same level of performance seen in reference labs [2].

"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."

Initially, the test will be mainly available in hospitals. Moreover, in an effort to preserve the resources for those in need, the test will be administered to people who are symptomatic but not to those who do not show symptoms. Considering that individuals with no symptoms can still spread the virus, it is crucial that strict prevention measures need to be adopted by all countries with confirmed cases.

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[1] https://www.cnn.com/2020/03/21/politics/fda-coronavirus-test/index.html

[2] https://www.cepheid.com/coronavirus

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