ldoadmin

In August last year, I blogged about new FDA guidance on laboratory developed tests and how these might restrict access to diagnosis and care for Lyme patients. Many patients with Lyme disease rely on laboratory developed tests, for example, the IGeneX western blot. Since that time, I have met with the FDA twice and LymeDisease.org conducted a survey which drew close to 8,000 responses. The results of that survey were presented to the FDA in our meetings and by Dr. Elizabeth Maloney at the FDA public hearing in January. On January 29th, LDo submitted official public comments to the FDA proposal.

LymeDisease.org has launched a new survey regarding the FDA’s proposed regulation of Lyme lab tests. We need your views on this very important topic. This is extremely time sensitive so please respond quickly! We will use this information to assess patient views and to inform our meetings with the FDA. Our last survey drew over 6,000 responses and was published this year. We need your input now!