FDA Approves At-Home Test for Chlamydia and Gonorrhea


The U.S. Food and Drug Administration (FDA) has approved a test for chlamydia and gonorrhea that people can buy without a prescription and use at home. While there are already several at-home diagnostic tests for sexually transmitted infections (STIs) on the market, this is the first to gain FDA approval since tests for HIV, the FDA said in a statement.

The Simple 2 Test will be sold over-the-counter and is intended for use by adults 18 and older, the FDA added.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, the director of the FDA’s Center for Devices and Radiological Health, in the statement. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more healthcare into the home.”

While both chlamydia and gonorrhea can be easily treated with antibiotics, they can also cause serious health complications, including infertility, if they go undiagnosed and untreated, according to the Centers for Disease Control and Prevention (CDC).


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