First bedside point-of-care test approved for COVID-19 virus

MedTech News: Cepheid point-of-care diagnostic test is the first to receive Emergency Use Authorisation from the U.S. Food & Drug Administration (FDA) for qualitative detection of SARS-CoV.

The test is designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, with a detection time of approximately 45 minutes.

Although the TGA is providing exemptions for the immediate supply of COVID-19 tests, the prospect of introducing this approach of identifying asymptomatic people and isolating them is not currently practical on a large scale. There are not enough tests to go around. COVID-19 testing is really targeted for high-risk patients and patients who show signs and symptoms of the disease. Broad based testing at this stage is simply not feasible.

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“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 healthcare facilities that need to properly allocate their respiratory isolation resources,” said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid.

“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.”

“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.” said Cepheid President Warren Kocmond.

The test will begin shipping next week in the U.S. and is pending review by international regulatory agencies, including Australia’s TGA.

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