Let It Out

US senators urge the release of a draft guidance on laboratory-developed tests.

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Any lab that is CLIA, CAP or

Any lab that is CLIA, CAP or JCHO certified has to validate any LDT before use. I think the FDA needs to stay out of it, and not regulate the practice of medicine.

Fixing a problem that doesn't

Fixing a problem that doesn't exist while raising medical costs for everyone..

Lab tests used to diagnose

Lab tests used to diagnose and treat patients need to be validated by an independent group, not the lab that is offering the test to generate profit for its investors. FDA is the best group for standardized validation, providing unbiased review and establishing clinical utility and making that data available for public review.

@ hafritsche -- Clinical Labs

@ hafritsche -- Clinical Labs that are CAP/CLIA/CMS regulated & qualified to perform these high complexity tests (as all LDTs are) are inspected every two years as a part of their licensure requirements. Newly validated assays are at the top of the list when Inspectors visit & the validation packets are thoroughly reviewed as a part of the CLIA inspection. CAP Inspection teams are licensed professionals that hail from the same lab setting as the lab they are inspecting (meaning that they often perform the same type of testing - technology wise, if not testing for the same analyte). There are CAP checklists & CLSI guidelines now that address the standardization of validation protocol requirements. Clinical utility is also increasingly becoming addressed in validations. Not all labs that validate & perform LDT tests are commercial labs with investors - there are hospital labs that develop these tests out of necessity to address an unmet need specific to their patient population. To turn this process over wholesale to the FDA would leave the patients that are cared for by these labs out in the cold as these smaller labs are often not equipped to make an FDA submission.

These law-makers are finding

These law-makers are finding work for themselves, where there is none.

They are democrats... More

They are democrats... More rules and regulations for business, more costs for the consumer and more power for the government. What else would you expect?

Having worked both sides

Having worked both sides (FDA-regulated IVDs and CLIA LDTs), I can attest that there are significant differences between LDT analytical validation and the FDA requirements for safety and effectiveness data. LDTs, by their very definition, generally do not undergo larger scale, randomized, prospective clinical trials. While that may be appropriate in some instances, it is simply not the same level of clinical evidence required for most diagnostics and devices. And clinical utility is not required for LDTs, even if some laboratories choose to do some studies, and study design is not always standardized. Thus, the regulation between CLIA/CAP and FDA with regard to IVDs is not equivalent. That said, FDA has said it supports the role LDTs have in the practice of medicine, and would prefer to have regulatory authority only for the highest risk classifications, and where it becomes known that a test is not performing and becomes a risk to public health. Common sense and compromise - what novel concepts!

As a consultant to the Office

As a consultant to the Office of the Center Director, FDA, I appreciate the need for better standardization/oversight of tests/IVDs that drive (often life and death) clinical decisions. But as a former drug developer, I understand the need for the application of companion diagnostics in an LDT setting until the cycle time of drug and Dx approval, as PMA or 510K, can be synchronized. Clearly, it is impractical (and not in the public's interest) for a phase III study of a new life-saving drug to be delayed for several months so that the companion diagnostic critical to that development can achieve full regulatory approval before being applied to late stage clinical trials.