Intermediary Genetic Testing Companies Face Less Regulation

by Dr. Hsien-Hsien Lei
Posted December 5, 2007 in DNA Testing

Your genetics start-up business tip of the day.

Last year, Dr Michael Hopkins, a Research Fellow at SPRU Science and Technology Policy Research at the University of Sussex, had some advice for DNA testing companies hoping to offer their services to the general public:

â€¦the successful ones [genetic testing company] have used a trusted third party to reduce their commercial risk. Using an intermediary organisation reduces the companyâ€™s exposure to criticism by consumer organisations and other groups.

It appears that the UK Human Genetics Commission agrees. From the December 2007 More Genes Direct report:

It is possible to regulate the laboratory which develops and provides the tests, but not the intermediary. Thus a company that has developed a new test and wants to make strong clinical claims for their test directly to consumers without regulatory scrutiny of those claims could do so via such an intermediary.

It’s not all as sleazy as the Human Genetics Commission would like to make it sound. “Intermediary” companies, like DNA Direct*, have high standards for the genetic tests they offer even if official government regulations don’t yet exist. DNA Direct’s standards include considerations on all fronts – pricing, test selection, marketing, informed choice, decision process, test interpretation, confidentiality, and operational. Without being too much of an employee cheerleader, I think it’s worth taking the time to read DNA Direct’s detailed standards because I believe they would impress even the Human Genetics Commission.

*I work for DNA Direct as a genetic information specialist.

Tags: genetics, genes, dna, dna direct, human genetics commission, genetic testing