LDT Oversight: Let’s Fix the Gaps, Not Fight in Court
I recently read a very interesting post using a “frozen dinner” vs “restaurant” metaphor to differentiate between in vitro diagnostic (IVD) test kits and laboratory developed tests (LDTs). (https://lnkd.in/gYv6ZHGJ). It suggests that IVD test kits are akin to frozen dinners (i.e., mass-produced with standardized instructions and labeling), while LDTs are comparable to restaurant meals (i.e., custom-made by skilled professionals with the flexibility to adjust recipes as needed). It appears logical then that applying identical regulations to both may not be appropriate, given their inherent differences.
While the restaurant vs. frozen dinner analogy is clever, it is grossly inaccurate as it completely ignores the severity and frequency of risks associated with LDTs. Unlike food, where varying taste and presentation may please different people, clinical test results must be consistent and reliable because lives depend on them.
There is no argument that many LDTs are developed and run by highly skilled professionals. However, we cannot ignore that some labs may prioritize financial considerations over rigorous validations essential to accurate and reliable test results. Without strong regulatory oversight, test results can vary between labs, leading to inconsistent diagnoses or risk assessments for the same patient. These discrepancies can result in misdiagnosis, inappropriate treatment, or missed opportunities for critical, lifesaving care.
While the restaurant analogy seems appealing to many, it misses a critical point: consistency matters far more in diagnostics than in dining.
A patient’s test result should not depend on which lab it comes from, just as a serious medical diagnosis should not vary like a chef’s special. Many LDTs operate with high standards, but the lack of uniform oversight means that results can, and do, differ between labs, sometimes leading to misdiagnosis or inappropriate treatment.
So, let’s take the restaurant comparison further:
· Has anyone ever ordered the same dish from two different restaurants and gotten different food?
· Would you want to get two different test results from two different labs for the same medical condition?
When it comes to healthcare, consistency is not just about preference – it is about patient safety.
FDA’s final rule may not be perfect, but it is a meaningful step toward ensuring that all diagnostic tests, regardless of where it is produced, meet a baseline standard for accuracy and reliability. Rather than fighting in court, we should work together to refine and improve the framework so that patients receive the best possible care. After all, the goal is not to stifle innovation, rather it is to make sure that innovation actually benefits patients without compromising safety.