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COVID-19 Rapid Diagnostic Test Approved by the FDA

RAPID diagnosis of COVID-19 is critical to reduce the spread of the virus to the public and healthcare providers around them. Until now, days would pass before the results of existing diagnostic tests were available, but a new COVID-19 molecular diagnostic test allows the detection of the virus within 45 minutes, the first to be approved by the U.S. Food and Drug Administration (FDA) for emergency use for COVID-19.

The test, which was developed by Cepheid, has received authorisation to be used for point-of-care COVID-19 diagnoses, which will facilitate deliverance of results to patients in the patient care settings, such as hospitals, urgent care centres, and emergency rooms, instead of samples being sent to a laboratory. Dr David Persing, Chief Medical and Technology Officer at Cepheid, commented that: “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.” The company plan to start shipping the tests ready for a 30th March roll-out, an incredibly rapid time for such an effort.

The development of this work was supported through a collaboration between the U.S. Department of Health and Human Services (HHS), the U.S. Department of Defense (DoD), and Cephied. The Biomedical Advanced Research and Development Authority (BARDA), a part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide Cepheid technical expertise and approximately $3.7 million in initial funding using an existing agreement between the company and the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).

Further funding is planned as the programme progresses, and future collaboration between BARDA, JPEO-CBRND, and Cepheid is also expected. The collaboration could include the development of a diagnostic test on the GeneXpert platform that can detect and differentiate known human coronaviruses and detect those that are novel or emerging. A test of this calibre could quickly alert healthcare providers and public health officials of future outbreaks of new coronaviruses, providing precious time to plan and take action to potentially prevent an outbreak or limit the spread of this new disease.