23rd March 2020 New test can detect COVID-19 within 45 minutes California-based biotech company Cepheid Inc reports that it has been granted FDA approval for a new rapid diagnostic test, able to detect the COVID-19 virus in just 45 minutes.
For many hospitals in the US, the current turnaround time on testing for COVID-19 is upwards of 24 hours – and in some cases, four days. Greater speed and capacity for detecting the coronavirus is desperately needed. A week ago, we reported on Swiss diagnostics maker Roche and its fully automated systems for processing swab samples. Roche's machines can generate a test result within 3.5 hours, which is 10 times faster than the company's previous version. Now, another company has stepped forward with a solution to accelerate the provision of testing for those who may be infected. This one is even faster than the machines developed by Roche. Cepheid Inc has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for detecting SARS-CoV-2, the virus causing COVID-19. The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, with a detection time of just 45 minutes.
As seen here, the GeneXpert System is scalable and usable in several configurations – from a single-cartridge version, up to the "Infinity" version which holds as many as 80 cartridges for processing simultaneously. "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, PhD, 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." "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." "Cepheid has nearly 5,000 GeneXpert Systems in the US capable of point-of-care testing and for use in hospitals," said Warren Kocmond, Cepheid's President. "Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7."
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