US-based healthcare solutions company LetsGetChecked has received the US Food and Drug Administration (FDA) marketing authorisation for its at-home Simple 2 Test.
The Simple 2 Test is designed to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause chlamydia and gonorrhoea, respectively.
It is an over-the-counter (OTC) test that can be purchased without a prescription, intended for use in adults aged 18 years and above, through a vaginal swab or urine sample.
The test comes with an at-home sample collection kit, validated for use with the FDA-approved Hologic Aptima 2 Combo Assay, with a prepaid shipping label to return the sample.
Simple 2 Test is the first diagnostic test for chlamydia and gonorrhoea with at-home sample collection to receive FDA marketing authorisation.
Also, it is the first FDA-authorised test with at-home sample collection for any sexually transmitted disease (STD) other than HIV, said LetsGetChecked.
LetsGetChecked founder and CEO Peter Foley said: “We are honoured to receive this landmark De Novo classification and authorisation from the FDA for our chlamydia and gonorrhoea testing system, which demonstrates the value of our robust end-to-end at-home care system.
“Our vertically integrated platform, coupled with the authorisation of our testing solution will empower individuals to proactively manage their health from home. We greatly appreciate the FDA’s collaboration throughout this process.”
FDA centre for devices and radiological health director Jeff Shuren said: “This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home.”
Once the individual collects the specimen at home using the collection kit provided with the test kit, it is then sent back to the designated laboratory for testing.
The samples are collected using Hologic’s Aptima collection devices, the Aptima Urine Specimen Collection Kit or the Aptima Multitest Swab Specimen Collection Kit.
The collected samples are analysed at LetsGetChecked’s high-complexity, CLIA-certified and CAP-certified laboratory in the US, using Hologic Aptima Combo 2 assay (for CT/NG).
LetsGetChecked will deliver the test results online, within two to five days with follow-up virtual consultations with a healthcare provider in cases of positive or invalid test results.
Hologic Diagnostics Solutions president Jennifer Schneiders said: “We are proud to support LetsGetChecked on this first-ever FDA-authorised at-home collection kit for chlamydia and gonorrhoea, which uses our best-in-class technology.
“Our priority as an organisation is to ensure people have access to the highest standards of care to safeguard their health.
“As STIs continue to rise at alarming rates, we are committed to innovative testing strategies that bring additional testing options to people everywhere.”
