FDA Approves First At-Home Test for Chlamydia, Gonorrhea
By Dennis Thompson HealthDay Reporter
THURSDAY, Nov. 16, 2023 -- 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.
People will be able to buy the Simple 2 Test over-the-counter at a pharmacy, take a specimen in the comfort of their home and send their sample to a designated laboratory for testing, 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 back in two to five days.
It’s the first FDA-aproved 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 tested.
“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release announcing the approval.
Chlamydia and gonorrhea are the first and second most common bacterial sexually transmitted diseases in the United States, according to the U.S. Centers for Disease Control and Prevention.
The 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 be easily treated with antibiotics, but if left untreated can lead to serious health complications, including infertility.
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 average folks 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
As a result, subsequent devices of the same type can go through FDA review by showing they are much the same as the Simple 2 Test, potentially saving developers some hassle and expense, the FDA noted.
“We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home,” Shuren said.
Sources
- U.S. Food and Drug Administration, news release, Nov. 15, 2023
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted November 2023
Read this next
Feds Announce New Measures to Monitor, Prevent Bird Flu
FRIDAY, May 10, 2024 -- H5N1 avian flu is now infecting U.S. dairy cows and the federal government on Friday announced a myriad of initiatives aimed at preventing the virus'...
His Cancer Journey Shows Health Dangers Firefighters Face
FRIDAY, May 10, 2024 -- For 14 years, David Perez fought fires in South Florida, thinking he was in peak physical shape. Then a routine physical turned up anomalies in his blood...
Baby Girl Born Deaf Gains Hearing After Gene Therapy
FRIDAY, May 10, 2024 -- Opal Sandy was born into a world she could not hear. The British baby girl, now 18 months old, had a rare genetic condition called auditory...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.