Author Archives: Lumigenix

Disease Risk Update

At Lumigenix we’re committed to regularly updating our customer’s results to reflect the most up-to-date genomic research.

We have recently updated our disease risk predictions to provide estimated lifetime risk for an additional 13 conditions. The updated conditions are:

  • Abdominal Aortic Aneurysm
  • Ankylosing Spondylitis
  • Basal Cell Carcinoma
  • Cerebral Aneurysm
  • Diffuse-type Gastric Cancer
  • Endometriosis
  • Glioma
  • Gout
  • Intrahepatic Cholestasis of Pregnancy
  • Melanoma
  • Parkinson’s Disease,
  • Systemic Lupus Erythematosus, and
  • Type 2 Diabetes.

This update means that all conditions with our highest evidence rating include lifetime and relative risks.

In addition to this change we also updated disease association data for Asthma, Systemic Lupus Erythematosus and Type-2 Diabetes.

If you are an existing customer, you will see these conditions updated when you next login.

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.