The FDA’s Aug. 7 public record covers the Xpert Hemorrhagic Fever test on GeneXpert Edge X systems and limits its use to U.S. Department of Defense laboratories; Cepheid announced a GeneXpert Dx clearance on Nov. 3.
The company describes Xpert as a multiplex polymerase chain reaction (PCR) test, meaning one run checks several viral targets. Cepheid says the panel operates on GeneXpert Dx systems and returns results in about 61 minutes. Its instructions for use, posted in the World Health Organization (WHO) resource collection, specify EDTA-treated venous whole blood. The test is intended to help evaluate people with symptoms or possible exposure; Cepheid says it is not available in all countries.
The panel targets Ebola, Marburg, Lassa and Crimean-Congo hemorrhagic fever viruses. Its Ebola component covers Zaire, Sudan, Taï Forest and Bundibugyo, but it cannot tell which of those four is present.
Cepheid’s instructions describe results as presumptive. A positive result needs additional testing for confirmation, while a negative result cannot rule out infection. The instructions also call for trained health professionals and appropriate protective equipment and safety precautions.
The WHO added the panel to its Bundibugyo virus disease emergency-use list on Sept. 1. A Nov. 2 update marked it “Available soon” and said the list’s assessment of products covered only their Bundibugyo detection claims. The list is specific to Bundibugyo virus disease, while Cepheid’s panel includes other viral targets.
Cepheid Chief Medical Officer Connie Savor said a rapid result can matter when symptoms suggest a viral hemorrhagic fever, adding that “every hour matters.”
An FDA record dated Aug. 7 covers the Xpert Hemorrhagic Fever test configured for the GeneXpert Edge X system. It limits use to U.S. Department of Defense laboratories with appropriate protective equipment and training. That record does not establish the scope of the GeneXpert Dx clearance Cepheid announced.
