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Q1: What is the purpose of the guide, and who is it meant for?
The guide aims to outline good practices for providers offering non-clinical genetic testing in Singapore, as well as to educate potential consumers and manage their expectations on such tests. The objective is to protect the safety, welfare and privacy of the consumers.
Q2: Why are non-clinical genetic tests allowed to be provided directly to consumers, but not clinical genetic tests?
As non-clinical genetic tests do not address medical conditions or disorders and are usually used for general wellness and recreational purposes (e.g. testing for innate behaviour or talents, fitness and nutrigenomics), they are assessed to be of lower risk and may be offered directly to consumers. Nonetheless, it is important for consumers of non-clinical genetic tests to be informed and take precautions for themselves in looking after their own interests. MOH has thus developed this guidance document and will enhance consumer education to raise public awareness of genetic testing.
In contrast, as clinical genetic tests are used to assess, diagnose, prevent, alleviate, predict risk or treat a medical condition or disorder, they should be administered by medical professionals with the appropriate knowledge and training. This is to ensure that a professional is involved to order the appropriate clinical genetic test(s) for the individual’s condition, interpret the test results, and provide the necessary management, counselling and support to the individual. This helps to avoid potential misinterpretation of or inappropriate follow-up to their clinical genetic test results, which could result in undue stress, anxiety and patient care concerns.
Q3: Is a genetic test considered “non-clinical” if most of the genes in the gene panel report on non-medical conditions?
No. The test is regarded as a clinical genetic test as long as it includes one or more gene(s) with the potential to report on a medical condition, even if the majority of the test panel report on non-clinical information.
According to paragraph 3.2 of the guide, a test that:
(i) has the potential to detect variants in genes that cause single gene disorder or medical condition; or
(ii) may inform the susceptibility of an individual to a clinically significant medical condition,
would be considered a clinical genetic test.
Q4: What should the providers do when selecting the gene or variant panel for their non-clinical genetic testing?
Genetic testing providers should conduct comprehensive, technical and scientific reviews of publications to ensure that the non-clinical genetic test provided does not have the potential to detect variants in genes that cause single gene disorders or medical conditions (please see paragraph 3.2 of the guide).
Genetic testing providers are also encouraged to refer to PubMed or other established databases such as ClinVar, ClinGen, OMIM and GeneCards for the latest publications on genetic testing.
Q5: Is MOH’s regulatory approach for clinical and non-clinical genetic testing consistent with international practice?
MOH has adopted a risk-based approach to regulate the provision of genetic testing. Providers are required to be licensed under the Private Hospitals and Medical Clinics Act (PHMCA), or in future the Healthcare Services Act (HCSA), for the provision of clinical genetic/genomic testing (CGT) services and clinical laboratory genetic/genomic (LGT) services in Singapore.
Similarly, in the US, the Food and Drug Administration (FDA) had adopted a risk-based approach and prohibited the provision of clinical genetic tests to be marketed and sold directly to consumers. While the prohibition was lifted in 2015, providers are now required to seek approval from FDA and comply with stringent controls and necessary safeguards prescribed in the Code of Federal Regulations Title 21 Part 866.5950 (Genetic Health Risk Assessment System).
As the provision of non-clinical genetic testing is considered to be of lower risk compared to clinical genetic testing, MOH has adopted a caveat emptor approach, similar to other overseas jurisdictions such as the US and Australia.
Q6: Would MOH’s regulatory framework for clinical and non-clinical genetic testing apply to overseas providers?
MOH’s regulatory framework would not apply to overseas providers as our legislation, such as the PHMCA and HCSA, generally does not have extra-territorial jurisdiction, even though some of their products may be accessible to local consumers through the internet. MOH has thus developed this guidance document and will enhance consumer education to improve consumers’ awareness and understanding of genetic testing, so that consumers are able to make informed decisions on the use of such tests.
However, if a local office or a local third party (acting as a middleman between the overseas provider and local consumers) is involved in the provision of CGT or LGT services in Singapore, the local office and/or local third party will be subject to the regulatory controls under the PHMCA, the Code of Practice on the Standards for the Provision of CGT and LGT Services and all other licensing terms and conditions, directives or guidelines which may be issued by MOH or other relevant agencies/bodies from time to time.
Q7: Why did MOH adopt the list of prohibited diseases, conditions and disorders from the Health Sciences Authority’s (HSA) Health Supplements Guidelines (2019)?
MOH’s risk-based regulatory approach to genetic testing is similar to HSA’s regulatory approach for health products. Providers offering CGT or LGT services are required to be licensed under the PHMCA or in future HCSA. Non-clinical genetic testing which is not used to screen or evaluate any medical conditions/disorders will not be regulated by MOH. This is similar to health supplements which are marketed and used for general wellness and non-therapeutic purposes but are not currently regulated by HSA. Conversely, any health products which purport to treat medical conditions or diseases would be considered as therapeutic products and fall within HSA’s regulatory scope.
Since the regulatory approaches deployed by HSA and MOH are similar, adopting the list of prohibited diseases, conditions and disorders in the HSA’s Health Supplements Guidelines (2019) would provide a good yardstick for MOH to differentiate between clinical and non-clinical genetic testing to protect the safety of consumers.
Q8: How would the guide be enforced?
The guide is meant to share best practices on the provision of non-clinical genetic testing as it is not a clinical service licensable under the PHMCA or in future HCSA.
To complement the launch of the guide, MOH would be embarking on consumer education to increase public awareness on genetic testing, including issues pertaining to the use of such tests and the need for proper interpretation of results.
Q9: Whom should I contact if I would like to seek further clarification on the guide?
For further clarification on the guide, you may contact the following:
• For provision of genetic testing in Singapore, please contact MOH via email at eLIS@moh.gov.sg
• For data protection provisions or Do Not Call (DNC) provisions, please contact Personal Data Protection Commission (PDPC) via email at Info@pdpc.gov.sg
• For matters of transactional nature, please contact the Consumer Association of Singapore (CASE) via CASE Consumer Hotline at 6467 9055.