Kits delivered to a person’s home helps remove the stigma of going to a sexual health clinic to get samples collected for testing. Image credit: Shutterstock/Polina Raulina.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.