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.

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, Dr Sara Whitburn.

Whitburn said the TGA’s findings “highlight the need for stronger evidence requirements and ongoing oversight of self-testing kits” and called for stronger “independent evidence, including peer-reviewed clinical data and real-world performance studies” before further future approvals of similar products.

skip past newsletter promotion

Free newsletter \| When needed

Sign up to Breaking News Australia

Get the most important news as it breaks

after newsletter promotion

She warned that false negatives can have serious consequences for individuals and their partners.

“As chlamydia and gonorrhoea are often asymptomatic, an undetected infection can remain untreated and be passed on to sexual partners. For some people, delayed diagnosis and treatment can lead to complications such as pelvic inflammatory disease, infertility and ectopic pregnancy,” Whitburn said.

Whitburn said “at-home STI self-tests can play an important role in making testing more accessible … they shouldn’t replace clinic-based care”, but stressed “a negative result doesn’t always rule out an STI”.

“In my view, at-home STI self-tests are a valuable option to support people to consider their sexual health and seek out testing for STI, but they work best as part of the broader healthcare system,” Whitburn said.

“If you used this self-test and received a negative result, you should see a doctor or visit a sexual health clinic for further assessment and have a laboratory test to confirm your result.”