Americans looking to stay on top of their sexual health have a new at-home option available to them. Earlier this month, the Food and Drug Administration authorized the first home test for chlamydia and gonorrhea. Developed by the company LetsGetChecked, the Simple 2 test costs between $58 and $99 a kit and returns results within a week.
Chlamydia and gonorrhea are both caused by bacteria. Though there are other more prevalent STIs in the population, such as HPV, chlamydia and gonorrhea are the most commonly reported STIs in the U.S. and other countries. These infections can cause acute symptoms like genital discharge, painful or burning urination, and bleeding between periods; left untreated, they can also raise the risk of infertility and pregnancy complications.
It can be difficult to manage STIs, in part because they often don’t cause noticeable illness. So the less that sexually active people are getting screened for STIs, the more likely that any given infection can spread to many others before it’s finally noticed. Annual STI cases have continued to rise in the U.S. in recent years, with an estimated 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea in 2021. Experts generally agree that more accessible testing is needed to stem the tide of America’s STI crisis.
“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement released on November 15. “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.”
The Simple 2 test can already be purchased now from the company’s website. The kit comes with tools for collecting urine specimens or vaginal swabs, which are then sent to a testing lab via a prepaid shipping label. Users are also asked to fill out an online questionnaire. After two to five days, the results will be available to view online, and people can arrange a virtual consultation with a health care provider through the company to obtain antibiotic treatment if they test positive.
The Simple 2 test’s list price is $99 dollars with free shipping. It’s currently discounted at $84, however. And people can sign up for a subscription service where they receive a test every three months for $58.80 a kit. The company also sells other, more expensive at-home tests that cover up to eight STIs, including HIV and syphilis.
While this is the first home test authorized in the U.S. for these STIs, LetsGetChecked may soon have some competition. This fall, the UK-based start-up Daye launched its own at-home STI screening service, albeit one that uses a specially designed tampon as its diagnostic tool. The tampon test is only available in the UK right now, but the company plans to seek regulatory approval in the U.S. and greater Europe in the near future.
