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Rahayu Mahzam on regulation of direct-to-consumer genetic testing

03:38 Min

The Ministry of Health takes a risk-based approach to regulating genetic testing. Clinical genetic testing to assess or treat medical conditions or disorders is regulated, but not direct-to-consumer (DTC) genetic testing for general wellness, ancestry and nutrigenomics purposes, which is assessed to be of lower risk. Senior Parliamentary Secretary for Health Rahayu Mahzam said this in Parliament on Thursday (Jul 6) in reply to an MP’s questions. She said her ministry issued a guidance document in 2021 which outlines good practices for providers of non-clinical genetic testing and educates consumers on the risks of such testing. These include exaggerated claims, possible sharing of data by third parties and the lack of proper medical interpretation of test results. She said the ministry takes a “caveat emptor” approach, meaning consumers must be aware that they have to protect themselves.

The Ministry of Health takes a risk-based approach to regulating genetic testing. Clinical genetic testing to assess or treat medical conditions or disorders is regulated, but not direct-to-consumer (DTC) genetic testing for general wellness, ancestry and nutrigenomics purposes, which is assessed to be of lower risk. Senior Parliamentary Secretary for Health Rahayu Mahzam said this in Parliament on Thursday (Jul 6) in reply to an MP’s questions. She said her ministry issued a guidance document in 2021 which outlines good practices for providers of non-clinical genetic testing and educates consumers on the risks of such testing. These include exaggerated claims, possible sharing of data by third parties and the lack of proper medical interpretation of test results. She said the ministry takes a “caveat emptor” approach, meaning consumers must be aware that they have to protect themselves.

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