FDA authorizes home tests for chlamydia, gonorrhea

By Jen Christensen | CNN

The US Food and Drug Administration has greenlit the first test for chlamydia and gonorrhea that will allow users to collect samples at home. After HIV, this is the first FDA-authorized test that will allow more accessible home collection for a sexually transmitted infection.

The Simple 2 Test, made by New York- and Dublin-based LetsGetChecked, got FDA market authorization Wednesday.

Up until now, people concerned that they might have chlamydia or gonorrhea would have to get tested at a doctor’s office.

Users of the new test won’t need a prescription and can activate it online. They fill out a health questionnaire for a clinician to go over, collect a vaginal swab or urine sample using the Simple 2 collection kit and then send it in to be evaluated. Test results are delivered online. If the test is positive or if the results are invalid, a health care provider follows up.

“This authorization marks an important public health milestone, 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 a statement.

Home diagnostic tests have become a more widely used option during the Covid-19 pandemic, and Shuren said the FDA is eager to support more opportunities for people to get access to diagnostic tests at home.

Peter Foley, founder and CEO of LetsGetChecked, told CNN in an email that the test “will empower individuals to proactively manage their health from home. We greatly appreciate FDA’s collaboration throughout this process.”

Gonorrhea and chlamydia are very common infectious diseases that can be passed from one partner to another through oral, anal and vaginal sex without a condom. Both infections can be treated with antibiotics.

Increased sexual activity during the pandemic, coupled with fewer routine screenings for sexually transmitted infections, supercharged the spread of these diseases around the world.

There were more than 700,000 cases of gonorrhea reported to the US Centers for Disease Control and Prevention in 2021. Rates have increased 118% since their record low in 2009, the agency says.

Symptoms of gonorrhea can include stomach or pelvic pain, increased vaginal discharge, painful urination and bleeding between periods. Many people don’t notice any symptoms, making routine screenings important to catch infections.

Without treatment, the infection can cause serious and permanent health problems. If it spreads to the blood, it can cause disseminated gonococcal infection, which can lead to arthritis, skin problems and tenosynovitis, which can cause pain and swelling. The condition may even become life-threatening.

Cases of chlamydia have also been on the rise, the CDC says. In 2021, there were more than 1.6 million cases reported to the agency, making it the most common notifiable sexually transmitted infection in the US that year. Symptoms include pain or burning while urinating, pain during sex, belly pain, abnormal vaginal discharge, swollen or tender testicles, and bleeding around the anus.

Chlamydia can also cause permanent damage to a woman’s reproductive system and make it difficult to get pregnant later. It can also cause an ectopic pregnancy, where the pregnancy happens outside of the womb.