New LDT Regulations on the Horizon

Technological advances are leading to the increased relevance of personalized medicine and genomic testing. Over the next few decades we will see a rapid development of these technologies which will result in improved medicinal efficacy and a reduction in the overall economic burden of the healthcare costs in the US. The FDA is aware of this trend, and as a result, has been forced to rethink the regulations concerning technologies such as Laboratory Developed Tests (LDTs) which will become increasingly more relevant as healthcare evolves. In 2013, companies such as 23andMe were selling Direct-To-Consumer LDT genomic testing services, which served as a catalyst for recent FDA actions. These tests fall under the definition of a medical device under Section 201(h) of the Federal Food, Drug and Cosmetic Act (FD&C Act), but the FDA has traditionally practiced “enforcement discretion” on LDTs. The only exception has been LDTs which contain analyte specific reagents (ASRs); ASRs are regulated as a class I device. The increased importance of LDTs has raised Public Health concerns. Specifically, the FDA is worried about how people will use data in making health decisions from services like 23andMe, which is not validated under FDA or Clinical Laboratory Improvement Amendments (CLIA) regulations. For example, someone may decide to have preventative surgery based on a genomic test result which is not backed by scientific evidence. This has caused controversy in how LDTs should be regulated, and it is now apparent that FDA intends to change their outlook on the regulations.

In July of 2014 the FDA publically announced that it would begin regulating LDTs, saying that the tests used to make important treatment decisions need to be subject to FDA oversight before they go into use. In addition, the FDA announced that they would be releasing two guidance documents regarding oversight of LDTs which should emerge soon. These documents, which will be first issued as draft guidance, are “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).” If you are a stakeholder in LDTs, you should pay close attention to the development of these regulations.

You can find more information on LDTs on FDA’s website here:

Posted by Spencer Kimber