FDA has now granted marketing authorization for the Simple 2 Test, which will be available over-the-counter and is the first non-HIV sexually transmitted disease test with at-home vaginal swabs or urine specimens.
Chlamydia and gonorrhea are the two most common sexually transmitted diseases, at over 2 million cases each year. They are easily treated but that means diagnosis and health care availability has become less available since the Affordable Care Act created a chasm between those with private health insurance and those using government versions.To help, FDA approval means the at-home kit will detect Chlamydia trachomatis and Neisseria gonorrhoeae bacteria and specimens are sent directly to a lab. Results are then sent online.
The Simple 2 Test is allowed under FDA’s De Novo premarket review pathway because it is a low-risk device. It will be sold under performance testing guidelines, so other products of the same type will be able to get market authorization without starting from zero.
This is a welcome change for FDA, and will lead to greater competition and therefore lower costs for the public - something the Affordable Care Act has failed to achieve.
Like any test, false positive and false negative results are possible so if you were exposed to someone with either disease, get antibiotics regardless of what the test says.
- Gonorrhea Map Shows How Antibiotic Resistance Spreads Across Europe
- Love To Love You Safely: Condoms Reduce STD Transmission And Unwanted Pregnancy
- QIAGEN And Abbott Enter Into Agreement On Molecular Tests For HIV, HCV And HPV
- Researchers Determine Clients Of Tijuana Prostitutes Engage In Risky Sexual Behavior
- Men Over 60 Who Pay For Sex: Less Protection, More Spending