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FDA Grants Emergency Clearance to mHealth Platform for Ebola Testing

The FDA has granted emergency use authorization to a fingerstick test that can be administered with an mHealth device, giving healthcare providers in Africa the ability to test for the Ebola virus in the field.

Source: ThinkStock

By Eric Wicklund

- With reports of a new Ebola outbreak threatening Africa, the US Food and Drug Administration has cleared the first-ever fingerstick test for the deadly virus that can be read on an mHealth device.

The DPP Ebola Antigen System, developed by Chembio Diagnostic Systems, was cleared for emergency use authorization (EUA) by the FDA last week alongside a portable battery-powered reader. The mobile health platform will enable healthcare providers to administer the test in the field, including emergency clinics positioned in hard-hit regions like the Democratic Republic of the Congo, where providers don’t have access to authorized Ebola virus nucleic acid tests (polymerase chain reaction testing).

“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “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.”

“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,” he added. “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.”

Under EUA authority, the FDA can “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.”

Ebola first caught the world’s attention in 2014, when the virus ravaged parts of sub-Saharan Africa, killing more than 10,000 people, and caused nations across the globe – Including the US – to declare medical emergencies. While that outbreak eventually wore itself out, several smaller outbreaks have occurred since then.

Researchers generally credit HealthMap, an online database created by Harvard Medical School and Boston Children’s Hospital, with identifying the outbreak’s origins in Guinea. That and other databases combed through medical records and social media channels to figure out where the virus was spreading and how quickly.

In addition, healthcare workers in Africa have been using mHealth and telehealth platforms to access the latest resources on virus containment and treatment and collaborate with infectious disease experts across the globe.

The FDA’s approval of the DPP Ebola Antigen System comes with several conditions.

“The DPP Ebola Antigen System should only be run in facilities, including treatment centers and public health clinics where patients are likely to be treated, and laboratories that are adequately equipped, trained and capable of such testing,” the agency said.

“While today’s action will increase access to diagnostic tools for healthcare providers who may not have otherwise been equipped to perform tests, it is important to note that a negative result from the DPP Ebola Antigen System, especially in patients with signs and symptoms of EVD, should not be used as the sole basis for patient management decisions,” the agency added. “The diagnosis of EVD must be made based on multiple factors such as, history, signs, symptoms, exposure likelihood and other laboratory evidence in addition to the detection of Ebola virus.”

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