A news release from the FDA: FDA authorizes emergency use of first Ebola fingerstick test with portable reader. Excerpt:
Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated.
The test, called the DPP Ebola Antigen System, is used with blood specimens, including capillary “fingerstick” whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to other risk factors, such as living in an area with large numbers of EVD cases and/or having contact with other individuals exhibiting signs and symptoms of EVD.
“The scourge of Ebola tragically demonstrates that we’re a global community when it comes to public health protection. Infectious disease doesn’t recognize nation states. Bacteria and viruses don’t respect territorial boundaries. It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats. We’re all in this together. To that end, our FDA team of experts in drugs, vaccines and diagnostics continue to collaborate with our Federal, international and industry partners to employ our collective expertise, experiences from previous incidents, and resources to assist in the global response to the Ebola outbreak in the Democratic Republic of Congo,” said FDA Commissioner Scott Gottlieb, M.D.
“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. We’re committed to helping the people of the DRC effectively confront and end the current Ebola outbreak. 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.”
The FDA’s EUA authority allows the agency to authorize the use of an unapproved medical product, or the unapproved use of an approved medical product when, among other circumstances, there are no adequate, approved and available alternatives. When circumstances exist justifying authorization, the EUA becomes an important mechanism that allows broader access to medical products that have not been FDA cleared or approved and are instead only authorized for use for the duration of an emergency declaration.
The FDA’s criteria for issuing an EUA for a diagnostic test include making an assessment that it is reasonable to believe, based on the totality of evidence available to the agency, that the test may be effective and the known and potential benefits of using the test outweigh its known and potential risks.
In 2014, during the Ebola outbreak in West Africa, an emergency was declared by the Secretary of Health and Human Services. While that outbreak has ended, ongoing, smaller Ebola outbreaks have continued, and the emergency declaration is still in place. Recent outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of an EUA for the DPP Ebola Antigen System is an important step in addressing these outbreaks.
