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When Is a Test Genetic? The Case of Multi-Cancer Early Detection Tests.

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    Multi-cancer early detection (MCED) tests are not typically classified as "genetic" tests. This distinction may impact whether insurers can access MCED results for risk assessment under current legislation.

    Keywords:
    Epigenetic testFragmentomicsGenetic TestGermline testingHereditary genetic disorderMetabolomicsMethylation patternsMulti-cancer early detection testProteomicsSomatic testing

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    Area of Science:

    • Biomedical Ethics
    • Health Law
    • Genomic Medicine

    Background:

    • Multi-cancer early detection (MCED) tests are gaining popularity for proactive health screening.
    • The classification of MCED tests as "genetic" is debated, impacting their regulatory oversight.
    • Insurers' access to genetic test results is often restricted to protect individuals from discriminatory risk assessments.

    Purpose of the Study:

    • To determine if multi-cancer early detection (MCED) tests meet the definition of "genetic tests."
    • To analyze legislative frameworks in three countries and one US state regarding insurer access to genetic testing data.
    • To assess the implications of MCED test classification for insurance risk assessment and underwriting.

    Main Methods:

    • Review of established definitions of "genetic tests."
    • Comparative legal analysis of legislation in select international and US jurisdictions.
    • Examination of statutory language and legislative intent concerning genetic information and insurance.

    Main Results:

    • MCED tests often analyze somatic mutations or epigenetic markers, not solely germline DNA, challenging a strict "genetic test" definition.
    • Existing legislation primarily addresses germline genetic testing, with limited explicit mention of MCED.
    • The ambiguity in definitions may allow insurers varied access to MCED results depending on jurisdiction and test methodology.

    Conclusions:

    • MCED tests may not fall under current "genetic test" legislation, potentially enabling broader insurer access.
    • Legislative clarity is needed to address the unique nature of MCED tests and their implications for insurance.
    • The distinction between germline and somatic testing is crucial for future policy development in genomic medicine and insurance regulation.