Monthly Archives: June 2011

Our response to a recent letter from the FDA

Last month, Lumigenix received a letter from the United States Food and Drug Administration (FDA) inquiring about our genetic testing service, as part of wider review by the agency.

At Lumigenix, we believe transparency is important. We are committed to providing direct access to high-quality personalized genetic testing, as well as to clearly and accurately presenting the benefits, risks and limitations of such tests.

We also believe that the importance of personal genomics extends far beyond the success of any one service or company. As the cost of genetic testing continues to decline, and individuals’ desire to explore their genetic data increases, it is apparent that personal genomics is here to stay.

But for all of its promise, personal genomics is not without its risks. For personal genomics to thrive, some form of industry oversight will be necessary.

While we are committed to working with the FDA and other regulatory bodies and stakeholders to develop clear and reasonable guidelines that balance innovation, access and risk in personal genomics, we believe that this process should be as transparent and public as possible. After all, it is you, the consumers of personal genomics products, who have the chance to benefit from responsible access to this technology.

For this reason, we have taken the unusual step of publishing our response to the FDA. Our response is available here.

We have also launched this blog to demonstrate that, in addition to welcoming the FDA’s feedback on our service, we value your feedback as well.