FDA approves home collection test for chlamydia and gonorrhea

USA — The US Food and Drug Administration (FDA) has given the green light to the first-ever at-home test for chlamydia and gonorrhea.

LetsGetChecked’s Simple 2 Test has received marketing approval, marking a significant leap in making sexually transmitted infection (STI) testing more accessible, following the precedent set by at-home HIV tests.

FDA’s approval of the Simple 2 Test allows individuals aged 18 and older to collect samples at home, transforming the landscape of STI testing.

This at-home collection method is a departure from the previous requirement for samples to be collected exclusively at medical facilities like doctors’ offices.

 “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.

The Simple 2 Test, available over the counter, eliminates the need for a prescription and offers a seamless online activation process.

Users complete a health questionnaire, which a clinician reviews. They then collect a vaginal swab or urine sample using the provided kit and send it in for evaluation.

The test results are conveniently delivered online, and if positive or inconclusive, follow-up care is initiated by a healthcare provider.

Peter Foley, CEO of LetsGetChecked, expressed gratitude for the FDA’s collaboration, emphasizing the empowerment of individuals to proactively manage their health from home.

Gonorrhea and chlamydia, both prevalent infectious diseases, can be transmitted through various forms of sexual activity without protection.

The increase in sexual activity during the COVID-19 pandemic, coupled with reduced routine screenings, has fueled the global spread of these infections.

In 2021, over 700,000 cases of gonorrhea were reported to the US Centers for Disease Control and Prevention, marking a 118% increase since 2009.

Symptoms of these infections range from stomach or pelvic pain, increased vaginal discharge, painful urination, to bleeding between periods. Routine screenings play a crucial role in early detection, as many infections are asymptomatic.

The long-term consequences of untreated gonorrhea include serious health problems, such as disseminated gonococcal infection, which can lead to arthritis, skin issues, and tenosynovitis.

Chlamydia, if left untreated, can cause permanent damage to a woman’s reproductive system, leading to difficulties in getting pregnant and an increased risk of ectopic pregnancy.

This FDA approval sets a precedent for future home tests for chlamydia and gonorrhea, paving the way for a streamlined regulatory pathway within the FDA’s approval process.

The integration of at-home STI testing into mainstream healthcare represents a pivotal moment in public health, offering individuals a discreet and convenient way to prioritize their sexual health.

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