Home genetic test kits and the TGA

Self-tests

Self-tests since 2010

The TGA’s page on its review of certain self-testing IVDs (in-vitro diagnostic medical devices) gives the history. Under the Therapeutic Goods (Excluded Purposes) Specification 2010, it says, self-tests for serious diseases, also called home-use tests, have not been allowed in Australia since 2010. The TGA says the exception is self-tests for HIV, which have been permitted since 2014.

It says a new instrument came into effect on 1 October 2020, and that self-tests for other serious diseases and infectious diseases, with cancer and genetic self-tests among them, will continue to be prohibited from supply. The page was last updated on 29 June 2023.

Which products those words reach is the TGA’s call, and its page is the place to check. This guide does not sort kits into or out of them.

Instrument

The Specification’s own words

The instrument in force now is the Therapeutic Goods (Medical Devices–Excluded Purposes) Specification 2020, on the Federal Register of Legislation. The compilation read for this guide on 8 October 2026 is Compilation No. 2, dated 28 October 2022. Section 6 of the Specification applies its Class 3 and 4 table to IVD medical devices for self-testing only, and not to devices meant solely for monitoring a condition a suitably qualified health professional has already diagnosed, solely for export, or solely for a government health screening program. In that table of excluded purposes, the part for Class 3 and 4 IVD medical devices has an item that reads, in part:

“testing specimens from the human body, other than to: … (b) diagnose, aid in diagnosis of, indicate the presence of, or test for the presence of markers that are precursors to, any of the following diseases or conditions, other than by genetic testing: (i) diabetes; (ii) kidney disease; (iii) cardiovascular disease; or …”

That is a selection, marked by the gaps. The paragraphs left out also take two more kinds of self-test out of the exclusion: (a) tests for eight named infections, among them HIV, hepatitis B and C, and syphilis, and (c) tests for SARS-CoV-2. The register sets out the whole item. The words to notice are the Specification’s own: the carve-out for those conditions is written “other than by genetic testing”.

Nutrigenetic tests

Nutrigenetic tests

The TGA’s second page is about nutrigenetic tests, and what follows is written for those tests only. It describes nutritional genomics as the study of how the human genome, nutrition and health relate to one another. Nutrigenetic tests are regulated under the framework for IVD medical devices, and depending on what the maker claims, some count as therapeutic goods and must then meet the requirements of the Therapeutic Goods Act 1989.

The page then says what therapeutic use means. In plain words, with the third item in the page’s own words, it is use in, or in connection with:

• preventing a disease, ailment, defect or injury, or diagnosing, curing or alleviating one
• influencing, inhibiting or modifying how a physiological process works
• “testing the susceptibility of persons to a disease or ailment”
• influencing or controlling conception, or preventing it
• testing for pregnancy
• replacing or modifying parts of the anatomy.

That is the page’s whole list, in its order.

Risk classes

Four risk classes

The page says the TGA’s level of oversight depends on how much risk an IVD poses to the public or to a person, and that a set of risk-based rules places each IVD in one of four classes. From the highest down:

1. Class 4High public health risk
2. Class 3Moderate public health risk, or high personal risk
3. Class 2Low public health risk, or moderate personal risk
4. Class 1No public health risk, or low personal risk

For nutrigenetic tests, the page says most are Class 3 IVDs and must be included in the Australian Register of Therapeutic Goods (ARTG), and that the manufacturer must hold evidence that a test complies with the Essential Principles. It also says nutrigenetic tests made for self-testing or home use, to find a disease or predict susceptibility to one, are excluded from entry in the ARTG.

Requirements

Requirements for makers and laboratories

Reporting

Reports to the TGA

The page encourages manufacturers, sponsors and users alike to tell the TGA when there is doubt about a test’s quality, safety or performance in its intended use. Users are named in that sentence beside the companies.