Chembio Diagnostics Inc. has secured approval to sell its combination test for HIV and syphilis in most of Europe and the Caribbean, officials said.
The Medford-based manufacturer of rapid diagnostic tests received the CE mark, which allows products to be sold in the European Union and the Caribbean, except for Puerto Rico.
Earlier, Chembio won approval to sell the test in Mexico and Brazil.
The blood test for HIV and syphilis provides a result in about 15 minutes and can be stored at room temperature. It has a shelf life of up to two years.
CEO John Sperzel said last week the test “can play a role in the global initiative to reduce transmission of HIV and syphilis to unborn children, as well as screen certain populations to address growing HIV and syphilis co-infection rates.”
The federal Centers for Disease Control and Prevention estimate there is a two- to fivefold increase in the risk of contracting HIV if the patient has already been exposed to syphilis. The centers also estimate that 2 million pregnancies each year are affected by mother-to-child transmission of HIV and/or syphilis, resulting in high rates of stillbirth, spontaneous abortion, low birth weight and perinatal death.
Sperzel said Chembio hopes to introduce the combination test in the United States once a clinical trial is completed. He said the company would apply for U.S. regulatory approval early this year.