Part 1: The Theranos Loophole & Lab Developed Tests
What’s the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.
Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today’s episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs.
Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor.
Some of the highlights of this episode include:
- Why Lab Developed Tests fit in with medical devices
- What the difference is in LDTs and IVDs
- How LDTs are regulated
- Examples of LDTs
- Why labs develop their own tests
- The risk when it comes to LDTs
- Why non-invasive LDTs can be listed as class 3
Memorable quotes from Mike Drues:
“A lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn’t regulate.”
“Remember, regulation is about the interpretation of words.”
“There is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it’s developed.”
“If the hospital does one thing, they’re treated one way; if a company does exactly the same thing, they’re treated another way. Something’s not quite kosher about that logic.”