PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) said industry stakeholders supported making in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza but self-tests for cancer and genetic testing for health-related purposes should continue to be prohibited from supply.

The TGA sought comments on whether certain self-testing IVDs should be prohibited from being sold to consumers. Australia’s current IVD regulatory framework was introduced in 2010, and at the time, several stakeholders raised concerns about the availability of home-use IVDs to test for serious diseases, such as infectious diseases, cancer and genetic disorders.

In 2010, stakeholders recommended that all genetic tests be excluded from use, emphasizing the importance of pre-test discussions and post-test counseling by health professionals. The excluded purposes specification came into force in July 2010, which does not allow certain self-testing IVDs to be sold to consumers. These include:

  • Tests for the presence of pathogenic organisms or transmissible agents (other than HIV), including agents that cause infectious diseases;
  • Genetic tests to determine the presence of or susceptibility to diseases;
  • Tests to diagnose or indicate the presence of a serious disease or condition, such as cancer or myocardial infarction; and
  • Tests for the presence of markers that are precursors to a serious disease or condition, such as Pap smear tests for cervical cancer or prostate specific antigen tests for prostate cancer.

In 2014, the excluded purposes specification was amended to allow for the supply of HIV self-tests in Australia following consultations that concluded the benefits outweighed the risks in supplying the test to the public.

The exclusion is about to sunset, and the TGA sought feedback on whether this exclusion was still fit for purpose or whether it should be altered.

New excluded purposes specification

Following consultations with industry, the TGA is amending the excluded purposes specification that will come into effect on Oct. 1, 2020, and will allow sponsors and manufacturers to apply to the TGA to include specified self-test devices in the Australian Register of Therapeutic Goods (ARTG). Any tests allowed under the excluded purposes specification can only be made available following evaluation of individual products to ensure appropriate risk mitigations are in place.

The supply of class III and class IV IVD self-tests for the following serious diseases and conditions will be allowed:

  • Chlamydia trachomatis;
  • Hepatitis B virus and hepatitis C virus;
  • Herpes simplex virus type 1 and 2;
  • Human immunodeficiency virus type 1 and type 2;
  • Neisseria gonorrhea;
  • Seasonal influenza virus;
  • Treponema pallidum (syphilis);
  • Diabetes;
  • Kidney disease; and
  • Cardiovascular disease.

The TGA stressed that IVD self-tests will be allowed for the seasonal strains of influenza virus only and does not include any strains that are novel or emerging, such as pandemic strains.

The supply of all other class III and class IV IVD self-tests for serious diseases, including self-tests for cancer and genetic self-tests, and class II IVDs for detecting fecal occult blood will continue to be prohibited unless they are being used for government screening programs.

Self-tests intended for monitoring a previously diagnosed disease or condition were not previously prohibited and can continue to be supplied.

Most against genetic self-tests

The majority of comments were strongly in favor of continued restrictions on direct-to-consumer (DTC) genetic self-tests.

However, some comments highlighted problems with Australia’s current regulation on genetic self-tests and pointed to the availability of self-tests from overseas providers that could circumvent the excluded purposes specification.

The TGA acknowledged that consumers are increasingly demanding genetic tests, and that since Australia is mirroring the EU medical device regulations, it would consider specific approaches to regulate genetic tests as part of that process.

Key concerns were ensuring the security and integrity of data and personal information obtained by DTC genetic testing companies, including its later use, as well as the potential for data collected for a non-health related purpose later being used for a health purpose. There was also concern about the potential for misinterpretation of the DTC genetic self-test data by consumers.

The views on self-tests for serious infectious diseases were more diverse. Some respondents strongly supported the future availability of several infectious disease self-tests, while others were more cautiously supportive.

After holding further targeted discussions with key stakeholders, the TGA confirmed that self-tests for serious infectious diseases should continue to be prohibited, except where there were greater benefits from the supply of certain self-tests, and the tests could be made safely available.

Potential benefits include increased uptake of testing in populations experiencing barriers to primary care such as people living in rural and remote areas and for people who would not otherwise seek testing. Self-tests could also reduce delays in testing and encourage earlier treatment.

The majority of respondents identified self-testing for hepatitis C and influenza as examples where the benefits are likely to outweigh the risks. Other respondents identified particular self-tests that may be safely supplied in the future, including other respiratory infections such as respiratory syncytial virus (RSV), hepatitis C virus, blood borne viruses, sexually transmitted infections and gastrointestinal and travel-acquired infections.

But concerns were raised that public health surveillance of serious infectious diseases could be compromised if self-tests for certain diseases were to be allowed. To that end, a limited number of self-tests will be made available.

Mitigating the risks

During the consultation it was acknowledged that consumers can purchase self-tests over the internet and these tests have not undergone any evaluation to verify their quality or performance. Risk mitigation strategies were discussed about how TGA evaluation could further mitigate risks.

The TGA determined that the evaluation of self-tests prior to approval will need to ensure:

  • They have a high level of sensitivity and specificity to minimize false negative and false positive results;
  • The sample collection, test performance and interpretation is straightforward and the instructions for use are easy to understand for lay persons;
  • Evidence is provided that the test performs satisfactorily in consumer usage studies;
  • The limitations of the test are clearly identified, such as limitations of antibody testing;
  • Testing during the “window” period, and the importance of re-testing in situations where there may have been recent exposure or repeated exposures;
  • There are clear instructions on when to seek clinical advice to confirm the presence of disease, obtain appropriate treatment and allow for notifiable infectious disease surveillance where necessary;
  • Information is provided on how to contact locally available support services; and
  • Consumers are aware of how to report poor performance of a self-test to the TGA.

Additional post-market requirements can also be imposed to help mitigate risk, such as the requirement to provide the TGA with periodic reports on the number of tests supplied and any adverse events; and post-market laboratory evaluation of the tests to verify performance.

The TGA will release further guidance on performance requirements and risk mitigations for specific self-tests being developed. This guidance will be similar to the guidance document relating to the clinical performance requirements and risk mitigation strategies for HIV tests.

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