| Gentest på beställning DNA-guide säljer DNA-tester för mer än 40 olika sjukdomar och egenskaper, samt test för ursprung. Ett testpaket kostar 3 700 kronor. I det ingår bland annat test för vinterkräksjuka, laktosintolerans, risk för blodpropp och för att utveckla Alzheimers sjukdom. |
– Det är en befogad diskussion. I USA har det till exempel startats ett antal rena bluffbolag som erbjuder DNA-tester. Ett regelverk för verksamheten skulle förhoppningsvis ge oss och andra seriösa företag inom området ett bättre rykte, säger Jeanette Axelsson, vd på DNA-guide.
| Från förslag till lag De nya EU-direktivet om medicinteknikprodukter för in vitro-diagnostisering har en bit kvar innan det träder i kraft. Förslaget bearbetas nu inom EU-kommissionen som före årsskiftet ska presentera en analys. Därefter ska EU-parlamentet och ministerrådet skriva ett lagförslag, vilket väntas komma tidigast andra kvartalet 2012. |
– Jag tycker att det är upp till kunden själv att bestämma om om han eller hon vill ta reda på risken för olika sjukdomar eller inte, säger Jeanette Axelsson.
De nya reglerna är en omarbetning av det nuvarande EU-direktiv som reglerar medicinteknikprodukter för in vitro-diagnostisering. Direktivet har hittills gällt gentester för diagnostik, som fostertester för olika genetiska sjukdomar. Däremot har det inte omfattat prediktiva tester, det vill säga tester som anger en viss risk att få en sjukdom.
– Ny teknik och ny forskning gör att det dags att omarbeta reglerna, säger Lars Johansson på Läkemedelsverket, som arbetar med EU-direktivet.
Hur de nya reglerna påverkar de kommersiella gentestföretagen kan Lars Johansson inte svara på, men Jeanette Axelsson är inte orolig för utvecklingen.
– Jag tror inte att det kommer att påverka oss så mycket. Det är förväntat att det kommer ett regelverk kring detta och vi är väl förberedda, säger hon.
De nya reglerna börjar gälla tidigast 2012.











































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