2023-11-17 01:15:00
Key PointsThe FDA approved the first home test for chlamydia and gonorrhea
It is the first authorized test with at-home sample collection for these sexually transmitted bacterial infections
The 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) — The first home test for chlamydia and gonorrhea will soon hit the market, following its approval Wednesday by the U.S. Food and Drug Administration. English).People will be able to purchase the Simple 2 Test without a prescription at a pharmacy, take a sample in the comfort of their home and send their sample to a designated laboratory for analysis, the FDA said. The test is produced by LetsGetChecked, a global healthcare solutions company focused on managing health from home. The company offers the test on its website for $99 and promises results 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. Until now, people would have to go to a doctor’s office to be examined. “This authorization marks an important milestone in public health, giving patients more information about their health from the privacy of their own home,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in an agency news release announcing the approval. Chlamydia and gonorrhea are the first and second most common sexually transmitted bacterial diseases in the United States, according to The U.S. Centers for Disease Control and Prevention rates of both are steadily increasing, with an estimated 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea in 2021, the FDA said. Both infections can They are easily treated with antibiotics, but if left undetected and untreated they can lead to serious health complications, including infertility. A person using the Simple 2 Test will provide a sample via vaginal swabs or urine samples. As part of the approval process, the FDA evaluated data showing that people can safely use the kit and have a general understanding of the results and what they should do next. Users will complete an online health questionnaire before submitting your sample, and your results will be delivered online. A healthcare provider will follow up in cases of positive or invalid results, the FDA said. The FDA reviewed the Simple 2 Test under a regulatory pathway for new types of devices that are low to moderate risk. The approval creates a new regulatory classification for this type of at-home test. As a result, subsequent devices of the same type can go through FDA review proving to be very similar to the Simple 2 Test, potentially saving developers some trouble and expense. “We look forward to continuing to support greater consumer access to diagnostic testing, which helps advance our goal of bringing more health care into the home,” Shuren said. More information The Centers for Disease Control and Prevention The U.S. Disease Prevention and Control Administration has more information about sexually transmitted infections. SOURCE: U.S. Food and Drug Administration, news release, Nov. 15, 2023
What it means for youPeople who suspect they have chlamydia or gonorrhea will soon have access to a home test.
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