Approval establishes a new device classification, meaning other similar home tests could potentially have an easier approval process in the future
THURSDAY, Nov. 16, 2023 (HealthDay News) — On Wednesday, the U.S. Food and Drug Administration granted marketing authorization to LetsGetChecked for the Simple 2 Test, the first home test for chlamydia and gonorrhea.
People will be able to buy the Simple 2 Test over-the-counter at a pharmacy, take a specimen at home, and send their sample to a designated laboratory for testing, the FDA said.
The test is produced by LetsGetChecked, a global health care solutions company focused on managing health from home. The company offers the test on its website for $99, and promises results back in two to five days. It is the first FDA-approved test with at-home sample collection for any sexually transmitted disease other than HIV, the agency said.
A person using the Simple 2 Test will provide a sample via vaginal swabs or urine specimens. As part of the approval process, the FDA evaluated data showing that most patients can safely use the kit and have a general understanding of both the results and what they need to do afterward. Users will fill out an online health questionnaire prior to sending off their sample, and their test results will be delivered online. A health care provider will follow up in cases of positive or invalid test results, the FDA said.
The FDA reviewed the Simple 2 Test under a regulatory pathway for new types of devices that are of low-to-moderate risk. The approval creates a new regulatory classification for this type of home test.
Marketing of the Simple 2 Test was granted to LetsGetChecked.