During its review of the product, the TGA said it was also alerted by a health service in May about \u201cfalse negative results from this test, affecting an unspecified number of patients\u201d. The TGA could not reveal which health service raised the concern.<\/p>\n
The regulator said it \u201cdoes not have a reliable estimate of how many users may have received false negative results\u201d.<\/p>\n
Touch Biotechnology\u2019s general manager, Mazz Gencer, said the company \u201cacknowledges the TGA\u2019s action and has ceased supply\u201d of the tests as \u201cfurther verification and performance testing are completed\u201d.<\/p>\n
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.<\/p>\n
Touch Biotechnology said it had followed \u201cthe established regulatory assessment process applicable at the time of registration\u201d to support its claimed limit of detection and overall performance, but declined to share any evidence, saying it was \u201cnot disclosing non-public regulatory submissions, documents or technical information\u201d.<\/p>\n
As part of the conditions of approval two years ago, Touch Biotechnology was required to maintain a post\u2011market surveillance report, including information on any adverse events, such as any reported false positive or false negative results.<\/p>\n
The company declined to provide findings of any reviews, saying it is \u201cnot disclosing non-public post-market surveillance records or technical reports\u201d.<\/p>\n
When the product was approved by the TGA in late 2024, sexual health experts urged caution, including the medical director at Sexual Health<\/a> Victoria, Dr Sara Whitburn.<\/p>\n Whitburn said the TGA\u2019s findings \u201chighlight the need for stronger evidence requirements and ongoing oversight of self-testing kits\u201d and called for stronger \u201cindependent evidence, including peer-reviewed clinical data and real-world performance studies\u201d before further future approvals of similar products.<\/p>\n
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