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DTC Genomics Report for HHS Expected by Year's End

NEW YORK (GenomeWeb News) – A report offering recommendations on ways to address "concerns" about genetic and genomic tests that are marketed directly to consumers, including new oversight proposals and measures for ensuring their clinical and analytical validity and utility, may arrive at the Department of Health and Human Services by the end of the year.

The Secretary's Advisory Committee on Genetics, Health, and Society agreed today that by the new year it should deliver to HHS Secretary Kathleen Sebelius its "Direct to Consumer Genetic Testing" report, which also will propose ways to deal with the marketing claims DTC testing companies make about their services, as well as ways to make information available to consumers about such reports.

Sylvia Au, the State of Hawaii's genetics coordinator who presented the draft report to the committee in June, told the group today that the report outlines the "benefits and concerns" and offers recommendations about how the concerns may be addressed. She said that the growing DTC genetic testing field, most popularly represented by companies such as 23andMe, Decode Genetics, and Navigenics, had generated much media buzz that spurred calls for oversight and consumer protection.

One proposal the committee discussed today would expand CLIA authorities, and perhaps those of the Food and Drug Administration, to cover the full range of health-related tests, including those offered directly to consumers.

That recommendation would advise HHS to support collaboration between a number of federal agencies, including FDA, the Centers for Medicaid and Medicare Services, The Centers for Disease Control and Prevention, and the Federal Trade Commission, to develop a definition of health-related tests that would apply to DTC testing.

The committee also may propose that the federal government develop strategies for protecting consumers from any potential harm such testing could cause and from unwanted compromises of consumer privacy.

The SACGHS report also likely will advise HHS to make educational resources such as web sites and others widely available to the pubic in order to enable them to make informed decisions about genetic tests and services.

The committee also has proposed that agencies, such as CDC, CMS, FDA, and FTC, strengthen their monitoring and enforcement efforts against labs and companies that make false and misleading claims about DTC tests, as well as other lab tests.

Another recommendation advises HHS to create a sustainable public/private entity of stakeholders that would to assess the clinical utility of genetic tests. Also on clinical utility, the report advises that HHS develop and fund a research agenda to evaluate genetic tests and develop evidence-based clinical practice guidelines for how those tests are to be used.

In her report today, Au proposed that SACGHS consider offering recommendations that would help HHS deal with "unclear or insufficient privacy protections," the "psychosocial impact of DTC genetic testing," and how these tests could exacerbate health disparities already existing in society.

In the months between now and its completion, the committee members also may consider drafting recommendations to protect how specimens, and the data derived from them, are used, and advice on standards for how genetic variants for disease risk are selected and validated, what terms are used to describe them, and how aggregate risk is calculated from multiple genetic variants.

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