Chembio Diagnostics Inc. plans to sell another of its rapid tests for HIV in Europe, beginning in the fall.
The Medford-based manufacturer of point-of-care tests for HIV, syphilis and other diseases said this week that European regulators had granted a CE mark to its DPP HIV 1/2 Assay test.
The CE mark clears the way "for commercialization and sale" of the test in the 28 countries that are members of the European Union, executives said.
A CE mark means a product complies with industry and safety standards in Europe and therefore can be sold across national borders within the region.
The DPP test uses blood and saliva samples and is administered by a health care professional. It is already available in the United States and in Central and South America, including Mexico and Brazil, chief executive John J. Sperzel said Thursday.
Recent studies have shown one third of infected Europeans are unaware of their HIV status and as many as 50 percent of those infected with HIV are diagnosed late, after symptoms have emerged.
"Early diagnosis of HIV provides a significant advantage to patients," Sperzel said. "It's been well documented that people who are diagnosed early and who receive early treatment can expect nearly the same life expectancy as those who are HIV-negative."
In April, Chembio announced that a CE mark had been granted for private-label versions of its HIV self-test called Sure Check.
That test uses blood samples and will be sold under other names by companies in Great Britain and France.