Companies in Australia and abroad are marketing various ‘health checks’ directly to consumers, without individual consultation with qualified medical practitioners. These are known as direct-to-consumer (‘DTC’) tests, which can be genetic or non-genetic in nature. These DTC tests include purported non-genetic cancer marker screening tests for diseases such as ovarian, bowel and prostate cancer from blood samples. Some companies are promoting DTC cancer marker tests to healthy consumers with the aim of ‘democratising’ pathology and healthcare and encouraging consumers to ‘take control’ of their health, while also potentially capitalising on fears of a cancer-related death. While some applaud the development of DTC tests, such tests raise ethical, medical and legal concerns. Whereas DTC genetic tests are subject to specific legal and policy regulation in Australia, DTC non-genetic tests — such as DTC cancer marker tests — are not. Australian regulation of such tests is piecemeal and fragmented. Using DTC cancer-marker tests as a case study, this presentation will examine the key ethical, medical and legal challenges of DTC non-genetic tests; the current regulatory framework in Australia; and will provide an opportunity to discuss ways to improve the regulation of these devices. As the concerns and challenges faced in Australia are likely to mirror those of other comparable jurisdictions and form an emerging example of technology disrupting traditional medical practice, this presentation will contribute to the exchange of learnings and ideas; highlight the need for effective regulation; and may identify potential future collaborative work on responding to innovation in healthcare.