I. Introduction

In the second part of our series of articles centring around the topic of longevity, we now discuss in greater detail, the emergence of geroscience, which is the study of ageing and chronic age-related diseases as one of the key domains of the longevity industry.

Associated with the rise of geroscience is the growing use of consumer genetic tests¹ to predict age-related diseases like cancer² and Alzheimer’s disease³. Additionally, depending on the genetic test involved, a sample of one’s blood, skin (through a cheek swab or otherwise), amniotic fluid or other tissue may be sent to a lab for analysis, where DNA, RNA, genes chromosomes and/or gene products are studied. A further distinction could also be drawn between “diagnostic genetic tests” which confirm or rule out a diagnosis based on existing symptoms, and “predictive genetic tests” which merely predict a future risk of disease. These services may be offered by overseas businesses (e.g. 23andMe and Circle DNA) or firms with offices in Singapore (e.g. Imagene Labs, e-beauty and easyDNA).⁴

In this article, we will explore the regulations concerning the commercialisation of genetic testing of age-related health conditions, originating from the geroscience and biomedicine sectors of the longevity industry.

II. Regulatory framework for genetic testing in Singapore

Under Singapore law, genetic testing is categorised into “clinical genetic testing” and “non-clinical genetic testing” based on the nature of the genetic testing in question. We set out a table below which sets out the distinction between clinical genetic tests and non-clinical genetic tests:⁵

Clinical genetic testing

The provision of clinical genetic tests is a licensable healthcare service under the Healthcare Services Act 2020 (HCSA) and the provision of clinical genetic tests without a licence is an offence under the HCSA. In June 2018, the Ministry of Health (MOH) released standards regarding the provision of “Clinical Genetic / Genomic Testing and Clinical Laboratory Genetic / Genomic Testing Services”. These standards were then issued as a “Code of Practice” in July 2018 (Code of Practice).

The Code of Practice sets out the minimum standards required for the provision of clinical genetic services. Under the Code of Practice, clinical genetic tests are categorised into three (3) levels according to the impact of the tests to the patient and his or her family (including the follow-up management required), the risk of inappropriate ordering of genetic tests, and the predisposition to wrong interpretation of test results.

Level 1 genetic tests (e.g. biochemical genetic tests, genetic tests of variants important in tissue matching, blood product transfusion) are tests:

1. that are likely to be appropriately ordered and correctly interpreted by most registered medical practitioners;
2. where most registered medical practitioners are likely to be able to appropriately explain the test results to the patient; and
3. where most registered medical practitioners are likely to be able to implement the appropriate referrals, investigations and/or follow-up plans based on the test results.

Level 2 genetic tests (e.g. genetic tests carried out on tumour(s), cancer associated tissues or bodily fluids, pharmacogenetic tests involving testing for a germline genetic variant(s)) are tests that would require the skills of appropriately trained registered medical practitioners to:

1. be correctly ordered;
2. correctly interpret the test results;
3. correctly explain the test results to the patient; and
4. implement the appropriate referrals, investigations or follow-up plans based on the test results.

Level 3 genetic tests (e.g. tests identifying presence of a germline variant) are tests that would require the skills of appropriately trained registered medical practitioners to:

1. be correctly ordered;
2. correctly interpret the test results;
3. correctly explain the test results to patients;
4. implement the appropriate referrals, investigation or follow-up plans based on the test results; and
5. correctly provide appropriate genetic counselling.

Based on the categorisation of a clinical genetic test, there are different standards to be met which include varying requirements pertaining to:

1. the registered medical practitioner providing such test;
2. conducting such test on adults with mental capacity, minors, adults who lack mental capacity and deceased individuals; and
3. the counselling, consent and disclosure of the test results.

Non-clinical genetic testing

Most non-clinical genetic tests are DTC genetic tests which are not regulated, and the MOH does not keep track of the number of DTC genetic test providers. However, the MOH has published a guide dated May 2021 for the provision of non-clinical genetic testing (the Guide). The Guide sets out the good practices for the providers of non-clinical genetic testing to safeguard consumers’ safety, welfare and privacy These good practices include:

1. ensuring that the advertisement, marketing material, test report containing results and subsequent follow-up services, do not carry any medical information and/or advice;
2. educating consumers on how the raw genetic information should or should not be used;
3. informing consumers of the strength of the scientific evidence of the tests and avoiding misleading statements;
4. disclosing the sensitivity, specificity, and predictive value of the genetic tests; and
5. not using or disclosing personal data without obtaining consent from consumers, and putting in place robust data security measures.

Apart from the Code of Practice and the Guide, any provider of genetic testing services must ensure compliance with all other applicable laws and regulations including the Healthcare Services Act 2020, the Personal Data Protection Act 2012 (PDPA), the Health Products Act 2007, the Human Biomedical Research Act 2015 (HBRA), the subsidiary legislation made under the aforementioned statutes and the directives or guidelines issued by the MOH or other relevant agencies from time to time.

III. Privacy considerations

Genetic testing may be used to study a person’s DNA, RNA, genes, chromosomes and/or gene products. Advances in genetics and genomics technology would naturally prompt this question: how can companies in the field of genetic testing services provide essential screening services while safeguarding consumer privacy?

In Singapore, the collection, use and disclosure of personal data by genetic testing service providers are primarily regulated by the PDPA which is administered and enforced by the Personal Data Protection Commission (PDPC). DNA-related information may be individually-identifiable and constitute personal data under the PDPA if it comprises health information which may identify specific individuals with other information that a genetic testing service provider has or is likely to have access.

The PDPA governs the collection, use, and disclosure of individuals' personal data by organisations in a manner that recognises both the right of individuals to protect their personal data, and the need of organisations to collect, use, and disclose personal data for purposes that a reasonable person would consider appropriate in the circumstances.

As we mentioned earlier, genetic testing services are also offered by overseas businesses (whether with or without offices in Singapore) that collect DNA samples from consumers in Singapore and send them to overseas labs for processing. Although the PDPA does not explicitly address territorial jurisdiction, genetic testing service providers should be aware that the PDPA could govern the collection, use and/or disclosure of personal data within Singapore, even if other part(s) of the data processing take(s) place somewhere else in the world. If genetic testing service providers transfer personal data from Singapore to overseas, such as storing the data in the cloud, they must ensure that the destination country offers a comparable level of data protection as is provided by the PDPA.

If the PDPC is satisfied that an organisation has contravened its obligations under the PDPA, it may give directions to the organisation to ensure compliance, in addition, individuals who suffer loss or damage directly as a result of a contravention of certain provisions in the PDPA may also commence civil proceedings against the organisation in breach.

On a separate but related note, the HBRA also prohibits various activities, including re-identification of anonymised information or biological material without consent and compelling a person to participate in a research.

IV. Concluding remarks

We believe that with the increasing sophistication of the population, the field of genetic testing is set to grow even further. Perhaps as a testament to this potential growth, MOH and the Life Insurance Association have developed the Moratorium on Genetic Testing and Insurance to prohibit life insurers in Singapore from using predictive genetic test results to assess the outcome of insurance applications, unless certain criteria are satisfied.⁶ It should not be surprising to see more safeguards and policies being put in place with the aim of achieving a balance between the quest to investigate an individual’s genetic makeup through genetic testing and the protection of that individual, thus making it imperative for businesses in the field of genomic technologies to keep abreast of regulatory developments in this sphere.

1. Rebekah Chia & Jefferson Lin Zi Xuan, “More taking DNA tests to predict diseases; KKH sees fivefold increase in demand,” The Straits Times (30 April 2023).↩
2. Clara Chong, “S’pore firm comes up with world’s first molecular blood test for early detection of gastric cancer,” The Straits Times (27 November 2022).↩
3. “Blood test could detect Alzheimer’s years before symptoms occur,” The Straits Times (6 December 2022).↩
4. Linette Lai, “Health Ministry warns of consumer genetic test risks to guide expectations” The Straits Times (16 May 2022).↩
5. Ministry of Health website.↩
6. Ministry of Health website.↩