Genetic testing at home? - The US loosens its regulatory framework for DTC genetic testing, Europe is taking the opposite direction
Instead of the established market entry procedure, which stipulates a comprehensive examination of the product for safety and efficiency, it’s now just a “one-time review” of the biotechnology company. This means that once companies have been accredited to the FDA (FDA pre-certification pilot program), current and future predictive genetic testing can be launched without further testing by the FDA. In this way, according to the FDA, new and innovative medical products should find their way into the market faster and more efficiently; but safety aspects will be still considered.
This step follows a path that was not foreseen a few years ago. For example, as of 2013, the American biotech company "23andme" was only allowed to sell genetic tests, after an intervention by the FDA, which make statements about kinship relations. At that time, the American authority stated insufficient evidence of these tests to make potentially far-reaching genetic risk predictions. It was not until April 2017 that a 23andme-branded DTC genetic test that can determine the risk of a total of ten disorders, including Alzheimer's and Parkinson's disease, was officially approved by the FDA. By comparison, prior to intervention of the FDA, the company's service consisted of the detection of about 200 genetically-related diseases. With the recent, far-reaching loosening of the regulatory framework, the FDA now apparently breaks with a restrictive handling of (predictive) genetic tests.
Which current and future DTC-related developments must be expected in Germany?
By §7 of the Genetic Diagnostics Act (Gendiagnostikgesetz; GenDG) DTC tests in the field of molecular diagnostics are legally inadmissible in Germany. Genetic tests, whether predictive or diagnostic, may only be performed by physicians. In addition, the approval or rather conformity assessment of these tests is uniformly regulated at European level. The In Vitro Diagnostic Regulation (IVDR 2017/746) even lists products for self-testing by patients / laypersons separately. This shows that the IVDR, which was only published in May 2017 and replaced the old IVD Directive (98/79 / EC), will continue to be product-related at European level and will not follow a firm-based approach, as in the United States.
However, it is undisputed that the area of genetic diagnostics and therapy is one of the most innovative and effective future fields of the upcoming decades, which will raise major questions of approval and reimbursement nationally and internationally. The thematic penetration and setting of strategic directions is therefore of immense importance. The SKC Beratungsgesellschaft mbH, strategy consultancy in the health care sector with many years of experience and profound practical, scientific and medical knowledge, provides advisory support in this exciting field.
For more information, please note the following links:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583885.htm
https://www.fiercebiotech.com/medtech/fda-loosens-rules-consumer-genetic-health-tests?mkt_tok=eyJpIjoiWWpBNFkyWm1NVEU1TkdVNSIsInQiOiI5NTJvTVE3NWVoZkZHKzVlZHVZVnJCTUN5ek03S2tkVzhNQVVBWm41Vk5cL0szZFUxOUhRbWRPWEtDdldSVVFjR0s0U2NiWkU5U2lZOVZKdWpuZmFIcEVoMTJRNmd1WXdFcXJPbjhVcklCRkN1ZXNwZlZtaFdJOEpjWk4xcjdGeVwvIn0%3D&mrkid=695240&utm_medium=nl&utm_source=internal
http://www.nature.com/news/23andme-given-green-light-to-sell-dna-tests-for-10-diseases-1.21802?WT.mc_id=TWT_NatureNews
https://www.fiercebiotech.com/regulatory/fda-allows-23andme-to-sell-dtc-genetic-tests-for-10-conditions
https://www.aerzteblatt.de/archiv/167563/Direct-To-Consumer-Testing-Fluch-oder-Segen-fuer-die-Patienten
http://e-health-com.de/details-news/fda-nickt-genetischen-risikotest-ab/17fc30254138586e78b8518294a1cbae/
https://www.nzz.ch/panorama/gentest-fuer-zu-hause-trotz-zulassung-nicht-ohne-risiko-ld.1015623