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November 12, 2018

Chembio Ebola virus test gets FDA approval for emergency use

Point-of-care diagnostics provider Chembio Diagnostics has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to use its DPP Ebola Antigen System to detect the Ebola virus.

Point-of-care diagnostics provider Chembio Diagnostics has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to use its DPP Ebola Antigen System to detect the Ebola virus.

The EUA covers the use of the Ebola virus test, in combination with epidemiological risk factors, for a presumptive diagnosis of people who display signs and symptoms of the Ebola virus disease (EVD).

DPP Ebola Antigen System comprises DPP Ebola Assay and a handheld, battery-operated Micro Reader. It is indicated for use with human capillary fingerstick whole blood, EDTA venous whole blood and EDTA plasma.

Based on the company’s DPP (Dual Path Platform) technology, the test is designed to identify viral antigens and delivers qualitative results in 15-20 minutes.

“We believe it will be a valuable tool to address the global threat posed by the Ebola virus, including the ongoing outbreak in the DRC.”

The system features a Micro Reader to minimise the risk of human error while interpreting the test results.

Chembio Diagnostics CEO John Sperzel said: “We are pleased to receive FDA emergency use authorisation for our DPP Ebola System as we believe it will be a valuable tool to address the global threat posed by the Ebola virus, including the ongoing outbreak in the DRC.

“Our patented DPP technology continues to serve as a robust platform for the rapid detection of infectious diseases, and we hope to receive support and funding as we pursue additional regulatory approvals for our rapid Ebola test.”

The DPP technology is intended for rapid, point-of-care diagnostic testing. Chembio developed multiple products using this platform, including tests to detect tuberculosis, HIV and Zika.

The company’s portfolio also includes diagnostics for Syphilis and Chagas.

In April, Chembio formed an alliance with LumiraDx to develop point-of-care tests to diagnose a variety of infectious diseases.

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