Regulation of nutrigenetic tests

Background

Nutritional genomics explores the relationship between the human genome, nutrition and health.

It can be divided into three subcategories:

• Nutrigenomics:
  • How nutrients and diet can influence the activity of genes, potentially impacting health and disease risk.
• Nutrigenetics:
  • How genetic variations affect diet and health, with implications for susceptible populations.
• Nutritional epigenetics:
  • How diet can case changes in gene expression with altering the DNA sequence itself.

Dietary recommendations can be based on genetic makeup using nutritional genomics. This prevents common multifactorial disorders decades before their clinical manifestation.

Practical applications arising from the science of nutritional genomics must be supported by stringent validation of any claims.

In this document, the term "nutrigenetic tests" is used and is intended to encompass all nutritional genomic assays that fall under the definition of therapeutic goods.

Regulation of nutrigenetic tests in Australia

Depending on what the manufacturer claims, some nutrigenetic tests are considered to be therapeutic goods. As a result, they must comply with the requirements of the Therapeutic Goods Act 1989.

Therapeutic use means use in or in connection with:

• preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury;
• influencing, inhibiting or modifying a physiological process;
• testing the susceptibility of persons to a disease or ailment;
• influencing, controlling or preventing conception;
• testing for pregnancy; or
• replacement or modification of parts of the anatomy.

Any nutrigenetic tests that are intended for therapeutic use, as defined above, will be required to fulfil the current regulatory requirements.

Regulatory requirements

Nutrigenetic tests are regulated under the framework for IVD medical devices.

Key elements of the IVD framework include:

• The manufacturing of IVD medical devices must ensure safety, quality, and performance are evident at all times when the device is used according to the manufacturer’s intended purpose.
• The level of regulatory oversight will depend on how much risk the IVD poses to the public and/or individual. This is by classifying each IVD according to a set of risk-based rules into 4 classes (Classes 1-4). IVDs classified as Class 4 have the highest regulatory oversight.
• Classification rules are:
  • Class 4 IVDs - High public health risk
  • Class 3 IVDs - Moderate public health risk or high personal risk
  • Class 2 IVDs - Low public health risk or moderate personal risk
  • Class 1 IVDs - No public health risk or low personal risk

The framework includes the regulation of IVDs produced both commercially and ‘in-house’.

• The legislation prohibits supply of self-testing IVDs for serious disease markers. Self-test IVDs for genetic testing to determine the presence of, or predict susceptibility to, diseases in humans are excluded under the Specification. Except where it’s used for purposes outlined in the specification.
• Key aspects of the IVD regulations in relation to nutrigenetic tests are:
  • Most nutrigenetic tests are Class 3 IVDs. They must be included in the Australian Register for Therapeutic Goods (ARTG). The manufacturer must hold evidence of compliance with the Essential Principles.
  • Access to nutrigenetic assays that are for self-testing or home-use to determine the presence of, or predict susceptibility to, diseases in humans are excluded from entry in the ARTG.
  • Commercial manufacturers must have in place a Quality Management System for manufacture. 
  • Many nutrigenetic tests are developed in-house by laboratories. In these cases, compliance with the regulations is a must. See, Part 6A, Schedule 3 of the Regulations.
• Nutrigenetic tests must have enough data to demonstrate their clinical and analytical claims. See, Part 8, Schedule 3 of the Regulations.
• Both commercial and in-house IVD manufacturers need post-market quality assurance systems.
  • Manufacturers and sponsors must report serious adverse events to the TGA.
  • If a test's quality, safety, or performance is in doubt, when used according to the intended purpose, manufacturers, sponsors, and users are encouraged to report it to the TGA.