The Principles for the translation of ‘omics’- based tests from discovery to health care are designed to assist researchers and clinicians in translating omics-based discoveries into properly validated tests that are clinically useful*.
Omics-based tests have the potential to improve patient health by providing information about risk or diagnosis of disease, by guiding clinical management decisions, or by enabling public health measures.
Omics-based tests are challenging to develop and verify because they typically involve the analysis of large DNA data sets using complex computer algorithms.
NHMRC recognised the need to develop Australian evidential standards or principles for the translation of omics-based discoveries into research-grade omics assays and clinical grade omics tests.
* Please note that the name of the Clinical Trial Exemption (CTX) scheme changed to the Clinical Trial Approval (CTA) scheme in 2020. This change was instigated to more accurately reflect the nature of the scheme under the Therapeutic Goods Act 1989. References in linked documents to CTX should now be interpreted as references to CTA.