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European Genetics Group Offers Draft of Genetic Testing Oversight

NEW YORK (GenomeWeb News) – The European Society of Human Genetics has issued a draft version of proposed recommendations for regulating and managing genetic testing and will be accepting public comments about its proposals until the beginning of July.

While some of the expectations raised by the arrival of the genomics era have yet to be realized, new studies about genes and their interaction with the environment offer promise for medicine, ESHG said.

The proposals were developed over three meetings over the past two years by ESHG's Public and Professional Policy Committee, by the EU-funded Network of Excellence Eurogentest, and by the Institute for Prospective Technological Studies.

Currently in Europe the regulatory framework does not cover an independent evaluation for genetic tests before they are marketed, and the general public has access to genetic susceptibility tests that are offered on the internet, according to ESHG. The society also is responding to varying definitions for genetic susceptibility testing and screening, and to new discoveries of genetic variants.

In the draft, ESHG proposed establishing an internationally recognized regulation for reviewing genetic tests, including those for common disorders, before they go to market, and the development of a post-marketing procedure for evaluating the tests.

The aim of a pre-market review would be to ensure truthful labeling and promotion of in vtiro diagnostic services, which currently are categorized as low-risk products that are not subject to independent evaluation.

In the European Union, ESHG said, various stakeholders should conduct an effort to harmonize regulations of gene tests, screening, and susceptibility screening. Harmonization, however, could involve development of professional protocols, standards for referral, and codes that could be used in health care practices.

The society recommended stakeholders work together to develop and fund a pre-market assessment along the lines of the European Diagnostic Manufacturers Association, which could bring industry together and work with regulators to draft new guidelines.

ESHG also recommends that governments continue to implement laws against discrimination based on genetic information, such as the US' Genetic Information Nondiscrimination Act, which would make sure that employers and health insurers use genetic information in responsible and ethical ways.

Action also should be taken, ESHG advised, to get stakeholders in industry, healthcare, and in patient and professional organizations to weigh the costs and benefits of issuing patents for genetic information.

Multidisciplinary teams should be formed between geneticists and other professionals to create cooperation in healthcare, and genetic resource centers and knowledge transfer centers should be created to help prepare healthcare providers for the arrival of genetics-based medical practices.

There also is a need for counseling for those taking susceptibility tests for diseases, particularly for genetic tests that detect high relative risk for serious conditions, ESHG said.

The group also said that healthcare professionals need to increase their literacy of genetics in order to assess genetic tests and genetic susceptibility tests and to respond to questions from patients.

Likewise, more information about genetic susceptibility testing should be disseminated among the general public using methods such as national or international websites that offer independent information about these tests, and about their benefits and drawbacks.

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