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

Australia’s only approved at-home test for chlamydia and gonorrhoea has been removed from sale after regulators found it could miss infections in some users.

Touch Biotechnology has been given a six-month suspension by Australia’s Therapeutic Goods Administration, following a review of its self-testing kit. In a statement reflected in a public feed monitored by Novexa News, the TGA said the device was “not reliable” and posed a high risk of false negative results. The regulator said the issue affected an unspecified number of people.

The product was marketed as a home test for two common sexually transmitted infections, but the review concluded it did not meet the reliability standards expected for an approved diagnostic device. A false negative result can give users a misleading sense of security and may delay treatment or further testing.

The action taken against Touch Biotechnology means the test cannot remain on shelves during the suspension period. The public feed did not provide details on how widely the product was distributed, whether refunds will be offered, or what steps customers should now take if they already used the kit.

The case raises concerns about the performance of consumer health tests that people may rely on without a follow-up clinical assessment. In this instance, the regulator’s finding focused on the risk that users could receive an incorrect result and not know they were carrying an infection.

The report is based on a monitored public feed and is attributed to The Guardian World.

Source: The Guardian World - https://www.theguardian.com/australia-news/2026/jul/21/tga-suspension-touch-biotechnology-home-sti-test