Experts warn unapproved ovarian cancer blood test poses risks of false alarms and distress
Health professionals and research foundations caution that the test’s specificity rate could generate thousands of false positives, leading to unnecessary medical procedures and psychological harm for women in Australia.
A commercial blood test for the early detection of ovarian cancer has sparked significant debate among Australian health experts, with critics warning that the service lacks regulatory approval and robust clinical evidence. The test, offered by BCAL Diagnostics for $1,495, utilises machine learning to analyse DNA fragments in the blood but has not been approved by the Therapeutic Goods Administration.
The service requires a referral from a general practitioner, which can be obtained via the company’s telehealth website. While online advertisements suggest the test is for any woman wishing to be proactive, BCAL Diagnostics states it is designed only for individuals at higher risk, such as those with a family history or genetic risk factors. Anne-Louise Arnett, the company’s chief executive, clarified that the test is not positioned as a general population screening tool or a standalone diagnostic.
However, health professionals have raised concerns regarding the test’s accuracy and potential for harm. The manufacturer reports a sensitivity of 78.2 per cent and a specificity of 94 per cent. Dr Barry Kramer, a cancer-screening expert and former director of cancer prevention at the US National Cancer Institute, calculated that in a group of 100,000 older women, the test could yield approximately 5,998 false positives. He noted that these results would likely lead to further testing, additional costs, and psychological distress for women who do not have the disease.
The Ovarian Cancer Research Foundation highlighted that peer-reviewed data on the test is limited, citing a 2025 study that included only 42 ovarian cancer samples. The foundation stated that the test does not yet meet the threshold for sensitivity and specificity required for clinical guidelines. Dr Brooke Nickel from the University of Sydney’s school of public health added that there is no robust evidence demonstrating that blood-based early detection screening tests improve health outcomes, even in higher-risk groups.
The Cancer Council’s public health committee chair, Anita Dessaix, emphasised that any test used for cancer screening must be supported by strong evidence showing that benefits outweigh potential harms. She advised that people should not ignore symptoms and should seek medical advice if concerns persist, rather than relying on unproven commercial screening methods.