In this blog we have regularly assumed (without hard data until now) that most biomarker innovation was taking place in laboratory-developed tests (LDTs) as opposed to tests cleared and approved by FDA, and we can now confirm that this assumption is correct.

Now that we include LDTs in BiomarkerBase we were able to analyze the number of tests that measure more than one biomarker, in both FDA-cleared and approved tests (IVDs) and laboratory-developed tests (LDTs), and the difference between the two test types is striking.

There are almost ten times as many LDTs that measure more than one biomarker than IVDs, and over twenty times more LDTs that measure more than five biomarkers.

This figure shows the number of tests – FDA-cleared and approved (IVDs) and laboratory-developed tests (LDTs) – that use more than one biomarker, by the total number of biomarkers used in the test (x-axis).