At-home STI test pulled from Australian shelves after failing to detect infections

Australia’s only approved at-home test kit for gonorrhoea and chlamydia has been suspended by the TGA. Photograph: ilkersener/Getty Images View image in fullscreen Australia’s only approved at-home test kit for gonorrhoea and chlamydia has been suspended by the TGA. Photograph: ilkersener/Getty Images At-home STI test pulled from Australian shelves after failing to detect infections Exclusive: TGA finds Touch Biotechnology test for chlamydia and gonorrhoea ‘is not reliable’ and has affected an unspecified number of people Get our breaking news email , free app or daily news podcast Australia’s only approved home test for chlamydia and gonorrhoea has been pulled from shelves after it failed to detect infections for an unspecified number of patients. Touch Biotechnology has been handed a six‑month suspension by the Therapeutic Goods Administration (TGA) after a review of the company’s self‑testing kit found “the device is not reliable … and poses a high risk for false negative results for users”. The product first hit pharmacy shelves in December 2024, with a typical retail price of $24. The STI test involves taking a vaginal swab that is then placed in a container with testing solution. A friend, Facebook or ... Ukraine? No easy surrogacy options for Australian families desperate for children Read more During its review of the product, the TGA said it was also alerted by a health service in May about “false negative results from this test, affecting an unspecified number of patients”. The TGA could not reveal which health service raised the concern. The regulator said it “does not have a reliable estimate of how many users may have received false negative results”. Touch Biotechnology’s general manager, Mazz Gencer, said the company “acknowledges the TGA’s action and has ceased supply” of the tests as “further verification and performance testing are completed”. At the time of approval, the company said its product correctly identified more than 99% of positive cases for both chlamydia and gonorrhoea when compared against urine PCR testing, and did not produce any false positives. Touch Biotechnology said it had followed “the established regulatory assessment process applicable at the time of registration” to support its claimed limit of detection and overall performance, but declined to share any evidence, saying it was “not disclosing non-public regulatory submissions, documents or technical information”. As part of the conditions of approval two years ago, Touch Biotechnology was required to maintain a post‑market surveillance report, including information on any adverse events, such as any reported false positive or false negative results. The company declined to provide findings of any reviews, saying it is “not disclosing non-public post-market surveillance records or technical reports”. When the product was approved by the TGA in late 2024, sexual health experts urged caution, including the deputy medical director at Sexual Health Victoria,