The U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid).
The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed.
“Today’s marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the U.S. Government, especially as we work with our partners, including the World Health Organization, to help address the current Ebola outbreak in the Democratic Republic of Congo (DRC),” said Acting FDA Commissioner Ned Sharpless, M.D.
“The current outbreak in the DRC has already killed thousands and the outbreaks in West Africa that began in 2014 tragically killed more than 11,000. Investigational vaccines and therapeutics have shown promising results, but one of the most important tools in stopping these outbreaks is quickly diagnosing patients and supporting safe and dignified burials. This marketing authorization may provide additional assurances to health care professionals seeking to use these types of rapid diagnostics. The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving. Additionally, this device could be used to support safe and dignified burials while helping to reduce the risk of transmission during those burials.”
Extensive efforts are underway by the Ministry of Health in the DRC to contain the current outbreak with support from the World Health Organization, the U.S. government, and other partners. These measures include campaigns to promote good hygiene, large-scale vaccination campaigns, specialized Ebola treatment centers where those infected or exposed to the virus can receive investigational therapeutics, and comprehensive efforts to trace and prevent the spread of EVD through vaccination campaigns, monitoring for symptoms, diagnostic testing, and implementation of infection prevention and control measures, such as safe and dignified burial procedures.
During the 2014 outbreak, the Secretary of the Department of Health and Human Services declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus. At the time, the FDA worked with CDC and test developers to make diagnostic tests, including the OraQuick Ebola Test, available through the Emergency Use Authorization (EUA) pathway. This pathway allows the FDA to temporarily authorize the use of unapproved medical products to address a public health emergency when specific conditions are met, including that there are no adequate, approved and available alternatives to the product for diagnosing, preventing, or treating the disease or condition.
The FDA has authorized a number of diagnostic tests for EVD under the EUA pathway to assist with the public health response. Today’s marketing authorization of the first EVD presumptive rapid diagnostic test for Ebola virus antigens through the De Novo review pathway reflects the ongoing collaboration between the U.S. Government and test developers to gather additional data on EUA products.
For the OraQuick Ebola Test submission, the FDA reviewed data from multiple clinical studies of blood samples and cadaveric oral fluid from the 2014 West African outbreak and from a variety of analytical studies. Based on these data, the FDA determined that general and special controls were necessary to provide a reasonable assurance of the safety and effectiveness of the OraQuick Ebola Test when intended to identify antigens associated with Ebola virus in blood from symptomatic patients and oral fluid of cadavers.
The OraQuick Ebola Test is intended for use in patients suspected of and with signs or symptoms consistent with EVD, and when the patient meets the CDC’s Ebola virus epidemiological criteria, such as history of residence in or travel to a geographic region with active EVD transmission at the time of travel. The OraQuick Ebola Test is not intended to be used for general Ebola infection screening (e.g., airport screening) or testing of individuals at risk of exposure without observable signs of infection.
The OraQuick Ebola Test was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. The FDA granted marketing authorization of the OraQuick Ebola Test to OraSure Technologies, Inc
