Medical Device Network

FDA approves first at-home chlamydia and gonorrhoea sample collection in US

Individuals in the US can now use the kit to collect samples at home for laboratory testing to determine presence of the two sexually transmitted infections.

The US Food and Drug Administration (FDA) has approved LetsGetChecked’s at-home testing system for chlamydia and gonorrhoea.

The De Novo authorisation by the agency means the device is the first FDA-approved home sample collection system for the two sexually transmitted infections (STIs) in the US. Until this point, only human immunodeficiency virus (HIV) sample collection systems had been approved.

The Simple 2 test includes an at-home kit to collect samples through vaginal swab or urine samples for individuals aged 18 and over.

The greenlight by the agency will allow adults to collect samples to test for chlamydia and gonorrhoea at home. The samples will then be analysed at LetsGetChecked’s laboratory, using Hologic’s Aptima Combo 2 assay. New York-headquartered LetsGetChecked said its service provides results in 2-5 days.

Self-collecting samples for chlamydia and gonorrhoea testing has been available for some time in the UK. England’s NHS has a partnership with SH:24, an online sexual health service, to deliver free kits to individuals who think they have been exposed to an STI.

Kits delivered to a person’s home helps remove the stigma of going to a sexual health clinic to get samples collected for testing.

The US Centers for Disease Control and Prevention (CDC) reported that in 2021 there were an estimated 1.64 million cases of chlamydia and more than 700,000 cases of gonorrhoea.

LetsGetChecked CEO Peter Foley said: “Our vertically integrated platform, coupled with the authorization of our testing solution will empower individuals to proactively manage their health from home.

Hologic Diagnostics Solutions President Jennifer Schneiders said: “We are proud to support LetsGetChecked on this first-ever FDA-authorized at-home collection kit for chlamydia and gonorrhoea.”

Point-of-care tests are also being employed to tackle the rising STI rates. In August 2023, diagnostics company binx health released data showing its chlamydia and gonorrhoea point-of-care test provided just as accurate results as a laboratory test in much quicker time.