Genetic testing is currently booming and is expected to be one of the most important drivers for personalized medicine. According to an article in Politico, multiple European initiatives are pushing Europe to realize the full power of genomics. Although the current European legislation patchwork complicates things, hope for a Europe-wide harmonization of laws is on the horizon.

Though technology has made it possible nowadays to sequence an entire genome within a week – 10 years ago it would have been months of waiting time – the patchwork of legislation in Europe makes it difficult to understand what is allowed and what is not. Opening up doors for a decrease of quality in genetic testing and slowing down innovators in the continent.

This patchwork adds more complexity to an already complex field. For example, French national laws allow tests to be covered under biomedical regulation, while Germany and Austria have laws specific to genetic testing. Other countries don’t have specific laws but regulate them as health services. Hope is on the horizon with, for example, the SIENNA project. This EU-funded effort will release guidelines for harmonized ethical frameworks and codes of conduct in the genetic field, as well as address issues of the inconsistently regulated field of genetic Direct-to-Consumer (DtC) tests.

The market for lifestyle genetics, currently dominated by DtC-testing companies, needs a more European-wide consistent clarification of the rules. According to the authors, today individuals who are curious about their genetic traits and not in particular affected by a disease, are left to the “Wild West” of the lifestyle genetics market. Hopefully, the new guidelines will not tend towards fundamental prohibitions and rather to a supportive framework that enables citizens to know their most basic information, if they want to, in a secure and quality manner.

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At GenomSys, sitting in the middle of Europe, we want to be part of the European evolution of genetic testing. The harmonization of legislation for genetic testing should have an increase of efficiency for DNA analysis, as was often the case with standardization. With our implementation of ISO international standardization of MPEG-G (ISO/IEC 23092) digital data format for genomic data, developed by European players in the lead, we provide a high level of data privacy, compression efficiency, and wide interoperability with the entire range of genetic legacy formats. As it is a true international ISO standard and the specifications are open, clear, and public, which makes it for users a future-proof solution.

Our goal is to support genetic experts with our GenomSys Variant Analyzer, which includes the benefits of our MPEG-G format, to increase the efficiency in the diagnostic laboratories. And to empower each citizen through our mobile app, within the future European legal framework, to take charge of their most intimate information. Digitally connecting both, to make personalized genomics a reality and help patients in the long-term.

Picture: Efraimstochter / pixabay

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