Cepheid announced that in response to the rapid outbreak of a new coronavirus strain, the Company is developing an automated molecular test for the qualitative detection of 2019-nCoV. The test will be designed for use on any of its 23,000 GeneXpert® Systems placed worldwide and is expected to deliver point-of-care results in about 30 minutes.
"The emergence of the 2019-nCoV outbreak has put significant pressure on healthcare facilities," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "An accurate test with a rapid turnaround time delivered close to the patient will expedite diagnostic testing and help alleviate these pressures. We plan to leverage 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 future pandemic coronavirus strains."
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Once finalized, Cepheid intends to access the FDA's Emergency Use Authorization pathway for regulatory approval and make the test available globally.
Providing access to timely, highly accurate diagnostics that improve patient outcomes and public health worldwide is at the heart of Cepheid's mission.