CNN —
The US Food and Drug Administration has recently approved the first-ever at-home test for chlamydia and gonorrhea. This FDA-authorized test allows for easier and more convenient home collection for a sexually transmitted infection, following the authorization of home tests for HIV.
The Simple 2 Test, developed by LetsGetChecked, based in New York and Dublin, received FDA market authorization on Wednesday as reported byCNN.
Prior to this approval, individuals concerned about chlamydia or gonorrhea had to visit a doctor’s office for testing.
The new test does not require a prescription and can be activated online. Users complete a health questionnaire to be reviewed by a clinician, collect a vaginal swab or urine sample using the Simple 2 collection kit, and submit it for evaluation. Test results are provided online, with follow-up from a healthcare provider in case of a positive result or an invalid test.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, stated, “This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home.”
Home diagnostic tests, particularly during the Covid-19 pandemic, have gained popularity, and the FDA is committed to expanding access to at-home diagnostic tests, according to Shuren.
Peter Foley, founder and CEO of LetsGetChecked, expressed that the test “will empower individuals to proactively manage their health from home,” and expressed appreciation for the FDA’s collaboration in the process.
Both gonorrhea and chlamydia are highly prevalent infectious diseases that can be transmitted through sexual activity without using protection. Antibiotics are effective in treating both infections, as recommended by CDC.
The pandemic has led to increased sexual activity and decreased routine screenings for sexually transmitted infections, fueling the global spread of these diseases, states Pew Trusts.
The US Centers for Disease Control and Prevention reported over 700,000 cases of gonorrhea in 2021, marking a 118% increase since 2009.
Symptoms of gonorrhea may include pelvic pain, abnormal vaginal discharge, painful urination, and bleeding between periods. Regular screenings are crucial for early detection, as many cases go unnoticed.
Untreated gonorrhea can lead to severe and lasting health issues, including disseminated gonococcal infection, resulting in arthritis, skin problems, and tenosynovitis, which can be life-threatening.
The CDC also reported an increase in chlamydia cases, with over 1.6 million cases in 2021, making it the most common notifiable sexually transmitted infection in the US. Early detection is key, as chlamydia can cause long-term damage to the reproductive system and increase the risk of ectopic pregnancy.
