A Medford manufacturer has won federal approval for temporary use of its diagnostic test to combat a potential outbreak of the Zika virus in hurricane-ravaged Puerto Rico, the U.S. Virgin Islands, Florida and Texas.
Chembio Diagnostics Inc. said Thursday that the federal Food and Drug Administration has okayed the company’s rapid test for Zika and companion results monitor for “emergency use” by some laboratories responding to medical problems caused by Hurricanes Harvey, Irma and Maria.
The FDA approval comes as health officials express concern about increased mosquito populations in the South and Caribbean after the hurricanes.
Some mosquitoes carry the Zika virus, which causes babies to be born with small heads.
Chembio’s blood test for Zika is the first of its kind to receive an FDA Emergency Use Authorization. The authorization allows the test to be used by labs that have been certified under the Clinical Laboratory Improvement Amendment to perform high or moderate complexity tests, according to Sharon Klugewicz, Chembio’s acting CEO.
She said the FDA approval was for a limited time.
“We believe the deployment of a rapid test for the presumptive detection . . . of [the] 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 U.S., Puerto Rico, and the U.S. Virgin Islands,” she said.
Chembio developed the Zika test in part with federal funding, which could eventually total $13.2 million.
The company also has rapid tests for HIV, syphilis, malaria, Ebola and other tropical diseases.
Chembio shares rose 20 cents Thursday to close at $6.20 on the NASDAQ Stock Market. They are down 12 percent in the past 12 months.