FDA cleared a fingerstick test for the Ebola virus Friday under its emergency use powers.
The diagnostic, Chembio Diagnostic Systems' DPP Ebola Antigen System, is the first FDA-authorized Ebola test with a battery-powered reader that makes it suitable for use outside of laboratory settings.
FDA granted emergency use authorization (EUA) to the diagnostic on the grounds that there is an unmet for an Ebola test and the potential benefits outweigh the risks.
There remains a pressing need for better ways to diagnose, treat and contain the Ebola virus. The need is illustrated by the current outbreak in the Democratic Republic of Congo, which, at 319 cases, is now the biggest flare-up of the virus in the country's history.
FDA has played a role in ensuring new tests are cleared for use as soon as possible. In the two years following the start of the 2014 Ebola outbreak, FDA cleared 10 viral assays and tests under the EUA pathway. The series of regulatory decisions gave laboratories access to Ebola tests but only covered one rapid fingerstick test suitable for use in the public health clinics where the disease is treated.
Sustained, robust and globally coordinated efforts are needed to fight infectious diseases like Ebola. #FDA experts in drugs, vaccines & diagnostics continue to collaborate with global partners to assist in this response. https://t.co/L8GTWnEdey— Scott Gottlieb, M.D. (@SGottliebFDA) November 9, 2018
The latest EUA could give public health clinics and treatment centers access to another test. The test uses the same underlying technology as Chembio's FDA-cleared HIV and Zika diagnostics. That means the DPP Ebola Antigen System should detect viral antigens within 20 minutes and be simple enough to use outside of laboratory settings.
The diagnostic has some limitations, though. A negative result from the test should not be used as the sole basis for treatment decisions, particularly if the patient shows signs of being infected by the virus. Despite that limitation, FDA thinks clearing the test under the EUA will further its efforts to help bring the Ebola emergency under control.
"This EUA is part of the agency's ongoing efforts to help mitigate potential, future threats by making medical products that have the potential to prevent, diagnosis or treat available as quickly as possible. By authorizing the first fingerstick test with a portable reader, we hope to better arm health care providers in the field to more quickly detect the virus in patients and improve patient outcomes," FDA Commissioner Scott Gottlieb said in a statement.
The clearance, like other Ebola EUA decisions, is valid for as long as the viral emergency continues.