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.
