Dr Bruce Quinn Describes How Europe and the US Regulate Diagnostic Tests Differently

While the FDA could regulate diagnostic tests the way they are in Europe—through simple verification that the test is accurate—the FDA has not chosen to do that and comes closer to requiring clinical utility, explained Bruce Quinn, MD, PhD, senior director at FaegreBD Consulting.

Transcript (slightly modified)

What shoud the FDA be focusing on more when it comes to diagnostic testing: clinical utility or clinical validity?

It depends what paradigm the FDA wants to use. The model that's used in Europe is simply to verify that the test is accurate. And for that reason a lot of kits are CE marked in Europe, they're used in the United Kingdom, they're used in Canada long before they're available in the United States, because they've simply proved that the test is accurate: it can detect these 5 mutations or those 7 mutations.

Although the FDA could do that, it has paired the approval with the actual drug activity for most combination diagnostics. So if a gene is known to be paired with a drug, they won't let you just produce an accurate genetic test by itself. The FDA requires it to be closely correlated with the drug outcome. I think we would solve a lot of problems if for those genetic tests we simply asked that the test be accurate, which is the standard that's used in Europe.

One of the issues for the FDA that brings it much closer to clinical utility, even if they don't use the word, is if they're looking at risk and benefit. And once you define the risk as being certain bad outcomes or certain disadvantages, you have to define the benefit to counterbalance that, and the benefit is really a clinical utility. It's something that's beneficial to the patient.