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UK Genetics Group Issues 'Principles' for DTC Testing

NEW YORK (GenomeWeb News) – The UK's Human Genetics Commission on Tuesday issued a set of principles for direct-to-consumer genetic testing that were drafted to provide guidance for consumers and to "promote high standards and consistency" among companies offering these tests.

DTC genetic testing "has increased dramatically over the last 10 years" and needs internationally accepted guidelines, HGC said.

The HGC principles center on the information and counseling consumers are provided before and after taking tests and on privacy considerations. They apply to all aspects of the industry, including marketing and advertising, consumer consent, lab analysis, and support for consumers.

"Some tests can cause considerable surprise or concern to those taking them – or give false reassurance," said HGC Commissioner Frances Flinter, in a statement accompanying the consultation paper. "Some, to say the least, are of doubtful value. We need a set of principles that can be adopted within existing legal frameworks in different countries."

HGC is not a regulatory body; it advises ministers in the UK on potential ethical and legal implications of genetic knowledge and its applications, and it expects that these recommendations will inform legislative decision making.

The guidelines were drafted by an HGC working group "with the interests of consumers at the front of our minds," Flinter said. However, he added, the consultation process "will give all those who have an interest in direct genetic testing the opportunity to influence the final version."

The HGC guiding principles propose that:

• Consumers need to be aware of possible outcomes, such as what they might find out and what they can do about it;

• Tests for serious hereditary diseases, such as Huntington's should include "before and after" counseling;

• Consumers should be provided with "easy to understand information on how genetic testing works and what the results mean";

• Companies should always make a test's limitations and the relative roles of genetics and lifestyle clear to the consumer;

• Companies must "take steps to keep DNA samples and genetic information secure," and ensure that they have the consumer's consent to perform genetic tests;

• In their marketing claims, test providers should not "overstate the utility of a genetic test" and they should describe their test's limitations;

• Test providers should make clear the criteria they use to include or exclude published literature that is cited as evidence of a test's applicability or effectiveness;

• Only clinically validated genetic variants should be used in genetic tests, and evidence supporting the association between a variant and a disease, condition, or trait should be supplied by the provider;

• Test providers should use only standard statistical methodologies for calculating genetic risk information given to consumers, and the provider's evaluation methods should be made available for review.

The full list of principles is available in the paper, entitled "A Common Framework of Principles for Direct-to-Consumer Genetic Testing Services."

HGC's said that the consultation will remain open for a comment period ending Dec. 6, 2009.