The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Cepheid’s molecular diagnostic test Xpert Ebola.
FDA has authorized the molecular diagnostic test under EUA for use by CLIA moderate and high complexity laboratories or similarly qualified non US laboratories.
Cepheid chairman and CEO John Bishop said: "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.
"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."
The molecular diagnostic test for Ebola Zaire Virus runs on the Cepheid GeneXpert Systems, a molecular diagnostic platform with more than 8,000 systems deployed in both developed and emerging market countries.
According to the company, Xpert Ebola has not yet received FDA approval and will be available as an EUA product in the US, until the declared emergency remains in effect or it ceases to be authorized by FDA.
Cepheid chief medical officer and technology officer Dr David Persing said: "With support from the Bill & 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."
The company plans to make the test available for patients from the next month.
Image: Electron micrograph of an Ebola virus virion. Photo: courtesy of CDC/Cynthia Goldsmith.