Although there is a general consensus in the field of laboratory medicine that all laboratory tests, including laboratory developed tests (LDTs), should be regulated, the consensus about LDT regulation ends there. Who or what should regulate LDTs is currently a debate that prompts strong feelings and differing opinions, mostly centered around whether the FDA or CLIA should regulate LDTs. FDA and its proponents feel that the FDA has the legal right, the duty and the wherewithal to regulate all LDTs. On the CLIA side, laboratorians like myself feel that CLIA is already regulating my LDTs and can continue to do so adequately with some modernization.
One of the problems that perhaps helps drive the controversy is the question – what exactly is an LDT? Is it a test that has been “tweaked” from the manufacturer’s IFU (instructions for use) by expanding the analytical measurement range or proving that the assay can be used with serum as well as plasma? Is it a test built from scratch using reagents ordered from Sigma and an instrument in a warehouse, and that will be mass marketed? Or is it something in between these extremes? Clearly defining what an LDT is and what it isn’t, with everyone agreeing on the definition, may help in determining who should regulate them.
From my perspective, CLIA already regulates every test I run in my laboratory. Modernizing CLIA to strengthen LDT regulation, perhaps adding in clinical validity, makes much more sense than adding a completely new and additional set of regulations on top of what’s already there. Additionally, CLIA, through its deemed associates, already has inspectors capable of inspecting LDTs. For example, CBG specialty inspectors inspect labs and areas of labs that predominately perform LDTs.
I’m unaware if the FDA is truly familiar with the full scope of the issue, i.e. almost every lab has tweaked an FDA-approved test in some manner. By defining these small tweaks to the IFU as LDTs, FDA is setting up every lab in the country to fall under FDA regulation. This is highly unnecessary, unwieldy and duplicative regulation. I’m also unaware if the FDA has the wherewithal to regulate and inspect almost every lab, not to mention that doing so would take FDA time and focus away from those tests in pop-up labs with internet marketing that really should be regulated by the FDA
Recently AACC and a consortium of healthcare associations asked CLIAC to take up LDT regulation in their CLIA modernization efforts. AACC and Other Healthcare Groups Urge CLIAC to Review LDT Regulations | The Lab Advocate NowThis would keep LDT regulation where it belongs, under CLIA.
Instead of layering on another regulatory agency and set of extremely tedious regulations, here are some ideas for a way forward:
- Define LDT clearly – AACC’s position statement is a good starting point. Modernization of CLIA: Laboratory Developed Tests (LDTs) | AACC.org
- Define who can perform them – e.g. high-complexity, CLIA certified labs, perhaps adding additional caveats, like: grandfathered in as CLIA compliant for X years, or associated with academic medical centers, or high complexity labs of any sort that predominately use FDA-approved tests and occasionally develop a test to meet a specific patient need.
- Modernize CLIA to clearly include LDT regulations – add in clinical validity. There are ways to prove an LDT is clinically valid that don’t involve additional patient studies – including the literature.
- Add any necessary additional training to CBG inspectors or all current lab inspectors to encompass the new aspect of LDT inspections.
- Don’t add more regulation and another regulatory agency on top of existing regulation.
These are my thoughts for moving forward with LDT regulation. I’m sure the discussion will go on.