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February 2019 | Published by RCPA

Issue #088

New RCPA position statement on direct-to-consumer genetic testing

New RCPA position statement on direct-to-consumer genetic testing

The Royal College of Pathologists of Australasia (RCPA) has released a revised position statement on genetic tests that are marketed directly to consumers. The RCPA strongly advocates that complex medical tests should always be requested by, and after discussion with, an experienced medical practitioner or other appropriately qualified health practitioner. This approach applies to all medical tests, however is particularly relevant for complex genetic tests that predict the medical future individuals, including children.

Dr Melody Caramins, Chair of the Genetics Advisory Committee, said,

“We have had concerns over direct-to-consumer genetic testing, particularly where it was indicated that testing was taking place without the involvement of an experienced medical practitioner. This has prompted the RCPA to undertake a major revision of its position statement,

“The RCPA strongly advocates that complex medical tests always be requested by, and after discussion with an experienced medical practitioner or other appropriately qualified health practitioner. Genetic test results can have significant health implications, not only for the individual being tested but potentially also for their relatives when testing for heritable genetic changes. It is not appropriate for genetic tests that deal with significant clinical issues to be marketed directly to patients, or for professional support to be provided only after the testing has taken place.

“Many people are interested in using genetic tests, which can be utilised for medical and non-medical purposes, to determine ancestry, predict medication sensitivity, predict the likelihood of developing particular diseases and of passing this predisposition to their children, and testing for acquired genetic changes in the oncology setting, which may help determine prognosis or treatment.”

A table outlining broad categories for genetic testing can be viewed here. Using this table, categories one to five should be regarded as categories of ‘Genetic testing for medical purposes’, categories six to 10 regarded as ‘Genetic testing for non-medical purposes’ and category 11 as an example of a test for non-medical purposes that could never be regarded as a potential direct-to-consumer test.

“Importantly, it must be noted that labelling a medical test as ‘For informational purposes only’ (or similar wording) does not change its category of testing from that of a complex medical test, to a lesser non-medical category. It is the inherent nature of the genetic test that determines its categorisation, not the labelling that the provider places on it,” said Dr Caramins.

For genetic tests that are used for any medical purpose, it is a legal requirement in Australia that most tests must be performed in a NATA/RCPA accredited laboratory. This ensures that the results are analytically correct and meet appropriate quality standards and that the test meets criteria for scientific validity. It also ensures that there is appropriate clinical supervision and oversight of the testing process and its interpretation.

For other genetic tests that may not necessarily be used for a medical purpose, it is strongly recommended that such tests should also be performed in an accredited laboratory, for the same reasons of ensuring appropriate standards of analytical accuracy and quality. Testing performed in an accredited pathology laboratory in Australia also ensures that the laboratory observes standards in relation to protecting patient privacy and confidentiality.

Many laboratories offering direct-to-consumer testing are not necessarily accredited to medical standards. Some laboratories are also based overseas and are not bound by Australian consumer protection laws. While this may not be relevant to the purpose of the tests being offered, it does mean that the laboratory might not be obliged to observe some of the customary safeguards medical laboratories adhere to in Australia.

“It is strongly recommended that the full ‘Privacy Policy’ (however named) and ‘Terms and Conditions’ of a direct-to-consumer laboratory service be carefully read and understood before providing any sample for testing. In particular, some of these laboratories reserve the right to release, forward or even sell samples or genetic information to external organisations. Once genetic information has been released to external parties, it is not usually possible to reverse or recover this information and it may have privacy consequences for the individual and their relatives,” said Dr Caramins.

The statement also recommends that, for non-medical testing, scientific claims are reviewed for plausibility. While some testing laboratories offering non-medical genetic services use techniques based on sound scientific principles, others offering testing to predict physical beauty, athleticism, intelligence or romantic compatibility should have their scientific validity carefully considered before accepting their claims at face value. Consumer protection and truth-in-advertising laws may not necessarily apply for direct-to-consumer services from overseas through sources such as the internet.







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