Cepheid’s Xpert Ebola diagnostic test gets FDA emergency use authorisation

24 March 2015 (Last Updated March 24th, 2015 18:30)

Cepheid has secured emergency use authorisation (EUA) from US Food and Drug Administration (FDA) for its molecular diagnostic test Xpert Ebola, which is capable of delivering results in less than two hours.

Cepheid has secured emergency use authorisation (EUA) from US Food and Drug Administration (FDA) for its molecular diagnostic test Xpert Ebola, which is capable of delivering results in less than two hours.

The molecular diagnostic test runs on the Cepheid GeneXpert Systems, which is a molecular diagnostic platform with more than 8,000 systems currently in use in both developed and emerging market countries.

Xpert Ebola was authorised for use by CLIA moderate and high complexity laboratories or similarly qualified non-US laboratories.

Cepheid chairman 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.

"Xpert Ebola was authorised for use by CLIA moderate and high complexity laboratories or similarly qualified non-US laboratories."

"The test runs in Cepheid's self-contained cartridge to minimise potential contamination."

The company said its Xpert Ebola has not yet been approved by the FDA, but will be available as an EUA product in the US, until the declared emergency remains in effect or it ceases to be authorised by the agency.

Cepheid chief medical and technology officer Dr David Persing said: "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.

"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."

The company intends to begin shipping the molecular diagnostic test in April.