What\u2019s 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\u2019s 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.
\u201cA lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn\u2019t regulate.\u201d
\u201cRemember, regulation is about the interpretation of words.\u201d
\u201cThere is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it\u2019s developed.\u201d
\u201cIf the hospital does one thing, they\u2019re treated one way; if a company does exactly the same thing, they\u2019re treated another way. Something\u2019s not quite kosher about that logic.\u201d