STAT November 15, 2023
The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country.
The marketing approval was granted to LetsGetChecked’s Simple 2 Test, which allows individuals to collect a sample at home that is then submitted to a laboratory for processing. Prior to this, the only approved tests for these two STIs required samples to be collected at medical facilities such as doctors’ offices.
“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, director of the FDA’s Center for...
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