When Congress at the end of 2022 failed to pass the VALID Act that would have establishing perimeters for the US Food and Drug Administration to regulate laboratory developed tests, it set in motion a chain of events that could spell pandemonium.
Key Takeaways
Ongoing lawsuits could upend the LDT industry, potentially leading to renewed interest in Congressional action.
The outcome will depend on the exact language of legal rulings, as well as actions taken under a new administration.
Scott Garrett, a partner in medtech-focused investment firm Water Street Healthcare Partners, believes some criticisms of the final rule are misguided.
