Here is a summary of our April, 2012 Quick Question:
The US FDA is planning guidelines for regulating laboratory-developed tests (LDTs). What plans have you made in response?
a. We are discontinuing all LDTs: 3 (15%)
b. We didn’t know this is happening: 11 (55%)
c. None, this will only apply to reference laboratory LDTs: 1 (5%)
d. We are improving on, and recording our LDT validations: 5 (25%)
We have had a relatively low response to this question, indicating a general lack of concern. From the linked commentary, it is likely this will first affect reference laboratories and tertiary-care institutions who are providing advanced laboratory testing, such as molecular diagnosis, to numerous clients and direct to consumers. The FDA may not have the resources to enforce these new regulations within individual institutions, however the bullets are likely to produce “powder burns” that will motivate us to beef up our LDT validations.