Chembio Diagnostics Inc. has won European certification for its combination test for three tropical diseases, executives announced.
The blood test for Zika, dengue and chikungunya has received the CE mark, which is necessary to sell products in Europe and most of the Caribbean.
The CE designation, an abbreviation of Conformité Européenne, comes three months after the Medford manufacturer won a contract to supply up to $3.5 million worth of the test to UNICEF. The sale was partially contingent on receiving the CE mark.
Chembio “looks forward to commercializing this test in the eligible European and Caribbean nations,” said John J. Sperzel, the company’s CEO. “We believe our multiplex test can be an important tool in combating these serious and sometimes deadly diseases.”
About one third of the globe’s population is at risk of infection from at least one of the three arboviruses: Zika, dengue or chikungunya, according to the World Health Organization.
The Chembio test yields a result in 15 minutes when used with a companion results reader, Sperzel said on Thursday.
Chembio develops and manufactures rapid tests for HIV, syphilis, malaria and other tropical diseases. The tests have been used by the WHO and others to combat recent outbreaks of Ebola and Zika.