Chembio Diagnostics Inc, Medford, NY, a provider of point-of-care diagnostics for infectious diseases, has received FDA emergency use authorization (EUA) for its DPP Zika system.

The DPP Zika system is the first rapid Zika test to receive an FDA EUA for use in laboratories certified to perform high- and moderate-complexity testing under the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The system includes the DPP Micro Reader, a handheld instrument that is easy to use and can reduce the risk of human error during test interpretation, and the DPP Zika IgM assay, which provides results in 15–20 minutes from only 10 µL of blood.

The test is authorized for the presumptive detection of Zika virus IgM antibodies in fingerstick whole blood, EDTA venous whole blood, EDTA plasma (each collected alongside a patient-matched serum specimen), or serum (plain or separation gel) specimens collected from individuals meeting CDC Zika virus clinical or epidemiological criteria, from 8 days to 12 weeks after the onset of clinical symptoms. The system utilizes the patented technology platform used in Chembio’s FDA-approved and CLIA-waived DPP HIV 1/2 assay.

FDA’s EUA permits the DPP Zika system to be used in US laboratories authorized to perform high- or moderate-complexity tests, or by similarly qualified non-US laboratories. The system has not been cleared or approved by FDA, and is only authorized for use for the duration of the Department of Health and Human Services (HHS) declaration that circumstances exist justifying the emergency use of in vitro diagnostic tests for the detection of Zika virus or diagnosis of Zika virus infection.

“We are delighted to receive FDA emergency use authorization for our DPP Zika system, and we appreciate the close interaction with FDA throughout the EUA process,” says Sharon Klugewicz, acting CEO of Chembio. “We believe the deployment of a rapid test for the presumptive detection of human IgM antibodies to Zika virus will be a critical tool in dealing with the ongoing spread of Zika virus, and we plan to make the DPP Zika system immediately available in the US, Puerto Rico, and the US Virgin Islands.”

Chembio’s development of the DPP Zika test was funded in part by HHS, the office of the assistant secretary for preparedness and response, and the biomedical advanced research and development authority (BARDA). Chembio has been awarded a contract for $5.9 million to develop the product and obtain FDA EUA authorization and 510(k) clearance, with the potential of $13.2 million in total funding from BARDA, if all options are exercised, to advance clinical development of the DPP Zika system and an equivalent DPP test system for chikungunya, dengue, and Zika viruses.

For more information, visit Chembio.