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LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of their own home.”

The Food and Drug Administration has authorized the first chlamydia and gonorrhea test with at-home sample collection.
LetsGetChecked received de novo authorization for the Simple 2 Test, an over-the-counter kit that uses vaginal swabs or urine specimens to detect the bacteria that cause the two sexually transmitted diseases (STDs).
The authorization will move sample collection from the doctor’s office to the home — potentially increasing testing of STDs, which are on the rise — and create a 510(k) pathway for rival diagnostics.
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Dive Insight:
Until this week, the FDA had only authorized at-home sample collection for one STD, HIV. Sample collection for all other STDs occurred at the point of care, for example, in a doctor’s office. People may be less likely to get tested at the point of care, particularly for frequently asymptomatic infections such as chlamydia and gonorrhea, because of concerns about confidentiality and convenience.

The Simple 2 Test will be offered direct to consumers, allowing them to purchase the test online without a prescription. Patients send samples to a laboratory for testing, and results are delivered online. A healthcare provider will then follow up if the results are positive or invalid.

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