U.S. health regulators approve Alere's HIV test
Aug 8 (Reuters) - The U.S. Food and Drug Administration approved health diagnostics and services company Alere Inc's test to treat two types of human immunodeficiency viruses (HIV) that cause the fatal infection, AIDS.
Determine HIV-1/2 Ag/Ab is the first approved test to be able to detect both the HIV-1 antigen and HIV-1, HIV-2 antibodies in a single test.
Alere shares were up 5.5 percent in extended trading after closing at $31.29 on the New York Stock Exchange on Thursday.
The FDA said in a statement that the detection of HIV-1 antigen allows earlier detection of the infection than by testing it for antibodies, which are produced in response to harmful antigens. ()
"This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner," said Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.
There are two types of infections, HIV-1 and HIV-2, the most common one being the HIV-1, and most cases of HIV-2 are found in Africa and has also been reported in North America and Europe, the FDA said.
According to the Centers for Disease Control and Prevention, about 50,000 people are infected with HIV in the United States each year.
Waltham, Massachusetts-based Alere makes a range of diagnosis tools such as home pregnancy tests and fertility and monitoring kits.