BIO Deutschland calls for the Directive by the Genetic Diagnostic Commission to Take Practice Requirements into Account

In March 2012, BIO Deutschland submitted a position paper calling for pragmatic regulations on parental testing. In its statement on the draft regulation[1] by the Genetic Diagnostic Commission (GEKO), the association emphasised that no further barriers should be established for small and medium-sized biotech enterprises active in the field of parental testing.  

According to GEKO’s regulation, the data on the person to be tested should be written not only in the documentation, but also on the sample container and swab. Furthermore, the regulation stipulates the provision of photographs and fingerprints of the person to be tested. As in the case of a third party identifying the person and documentation of the contact and ID data, BIO Deutschland believes that this is not justified and cannot always be put properly into practice without considerable effort. Codes consisting of numbers or letters could be used to match swabs and sample containers to the data on the person to be tested contained in the documentation in order to avoid cases of mistaken identity.

BIO Deutschland’s Working Group on Diagnostics also found that a confirmatory test, as called for in the directive, would create an incongruous amount of extra work and unnecessarily hold up the day-to-day routine. The working group believes that this measure should only be used to check that the exclusion constellation was not mistakenly caused by sample permutation or contamination in the laboratory. However, quality management should ensure that the work process is organised in such a way that this type of mistake cannot occur.

An act on genetic testing on humans (the Genetic Diagnostics Act) came into force in Germany on 1 February 2010. The Genetic Diagnostic Commission established at the Robert Koch Institute was tasked with creating regulations in a legal framework for the various aspects of the act (section 23). Paragraph 2, no. 2b of this section stipulates that the Genetic Diagnostic Commission will produce regulations on the qualification requirements for medical and paramedical experts experienced in the field of parental testing on the basis of generally recognised scientific and technological standards in accordance with section 17, paragraph 4 of the Genetic Diagnostics Act.

Members of BIO Deutschland are welcome to request a copy of the position paper from the association’s office (tel.: +49 (0) 30-3450593-30, e-mail: info@biodeutschlang.org). Please note that the text is only available in German.