FDA has granted emergency use authorization to the Xpert ebola test by Cepheid, Sunnyvale, Calif, a molecular diagnostic test for ebola virus that delivers results in less than 2 hours.
The test is performed using the Cepheid GeneXpert system, a molecular diagnostic platform with more than 8,000 systems deployed globally in both developed and emerging market countries. Minimizing potential contamination, the test runs in a self-contained cartridge.
“We developed Xpert ebola with a dual-target design to ensure high accuracy and sensitivity for detecting the ebola Zaire virus, detected in the West Africa outbreak in 2014,” says John Bishop, Cepheid chairman and CEO. “Cepheid has historically played a leading role in developing molecular diagnostics as an aid to infection control efforts, and the current ebola crisis represents an extreme example of the need for sensitive, fast, and easy-to-use diagnostics to aid in patient management and isolation requirements. We believe this is a major step in strengthening the arsenal of tools being deployed to address the current situation.”
On August 5, 2014, US Secretary of Health and Human Services Sylvia Burwell declared that circumstances existed to justify emergency use authorization of unapproved in vitro diagnostics for the detection of ebola virus. Although Xpert ebola has not been FDA cleared or approved, it will remain available in the United States as an EUA product as long as the declared emergency remains in effect or until FDA withdraws its authorization. The system has been authorized for use by CLIA moderate- and high-complexity laboratories or similarly qualified non-US laboratories.
“With support from the Bill and Melinda Gates Foundation and the Paul G. Allen Family Foundation, provided via the National Philanthropic Trust Fund for Global Health and Development, Cepheid was able to leverage its extensive development experience to expedite delivery from the initial prototype to an emergency use only product in just 90 days,” says David Persing, MD, PhD, Cepheid’s chief medical and technology officer. “We expect that this technology will help to expedite the evaluation of suspected cases and to enable more effective field surveillance activities already underway in endemic areas.”
Tests will begin shipping in April 2015.
For more information, visit Cepheid.