Look out! Zika!
The Zika virus has become a global concern since its epidemic in 2015-2016. During that time, on February 26, 2016, Sylvia Burwell of the US Health and Human Services declared the authorization of emergency use of in vitro diagnostics for the detection and diagnosis of the Zika virus.1 According to the PharmSource Lead Sheet: Device & Diagnostics Edition, since February 2016, there have been 14 diagnostic tests that have been granted FDA Emergency Use Authorization with two more currently being developed.
The chart below was extracted from the PharmSource database showing which companies have received approval and which are currently developing a Zika diagnostic test.
There have been two Zika diagnostic tests that have been approved outside of the US. Bioneer, headquartered in South Korea, received CE Mark and South Korean approvals for its AccuPower ZIKV virus detection kit and Chembio Diagnostics, headquartered in New York, US, received CE Mark and Brazilian ANVISA approvals for its point-of-care Dual Path Platform (DPP) Zika IgM/IgG Assay.
As Zika cases continue in the US, which can be seen in the following map from the CDC, as of March 22, 2017, companies also continue to develop diagnostic tests that are faster, cheaper and can even be used on a smartphone application platform.
1Emergency Use Authorizations. (2017, March 21). Retrieved March 24, 2017, from https://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm#zika