Regulation of Epigenetic and Biological Age Tests as Clinical Diagnostics and Extension of Safeguards to Protect Genetic Information Results

Dr Hamid Razak asked the Coordinating Minister for Social Policies and Minister for Health (a) whether commercially-marketed biological age tests, including epigenetic or Asian cohort-based algorithms, are regulated as clinical diagnostic tests; and (b) whether the proposed Bill to protect genetic information will extend safeguards to results from such consumer-facing ageing assessments.

Commercially marketed biological age tests that are intended solely for general wellness purposes and do not claim to assess, diagnose, treat or prevent any medical condition, are generally regarded as non-clinical tests. Hence, they are not regulated as medical devices under the Health Products Act.

The proposed Bill to protect genetic information is intended to cover all genetic information, regardless of whether it comes from clinical, research or commercially available genetic tests.