Do-it-yourself tests and devices to screen for and monitor disease can play an important role in disease prevention and management. For example, self-testing kits for bowel and cervical cancer as part of approved National Screening Programs and blood pressure and cholesterol monitors to manage heart disease. But not all do-it-yourself health tests have proven worth. Companies in Australia and abroad are marketing various ‘health checks’ directly to consumers online, without individual consultation with qualified medical practitioners. Known as direct-to-consumer (‘DTC’) tests, these can be genetic or non-genetic in nature and 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 to ‘democratise’ pathology and healthcare and encourage consumers to ‘take control’ of their health, potentially capitalising on fears of a cancer-related death. While some applaud the development of such DTC tests, they raise several concerns relating to clinical validity and utility, quality control, informed consent, data confidentiality, psycho-social distress, and unnecessary testing and follow-up procedures. The DTC test market has flourished overseas and is an emerging issue for the Australian cancer community. Australian regulation of DTC tests is piecemeal and fragmented. Whereas DTC genetic tests are subject to specific regulation, DTC non-genetic tests — such as DTC cancer marker tests — are not. Focusing on DTC cancer-marker tests, this presentation will examine the key concerns of DTC tests; the current regulatory framework in Australia; and the case for more effective regulation of these products to ensure safety and quality care. With the legal supply of DTC tests in Australia currently under review by the Therapeutic Goods Administration, now is the time to consider how best to respond to this latest innovation in healthcare that currently presents more problems than promise.