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LDT Biomarker Panels: A First Look

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work in laboratory

Having recently conducted an analysis of biomarker panels in FDA-approved tests, we are now beginning to analyze biomarker panels in laboratory-developed tests (LDTs). To my knowledge this is the first publicly available analysis of LDTs.

Utilizing a proprietary data gathering and filtering tool, we pulled down the test menus from the public websites of Quest Diagnostics, ARUP Laboratories, and Mayo Medical Laboratories.

We then filtered the menus for tests that are designated as panels, yielding 310 tests in total, which dwarfs the 43 panel-based tests cleared or approved by FDA over the last 12 years (and this from just three LDT developers).

The orange bars represent the total number of tests that measure 3 or more biomarkers, by test source. The orange bars represent the total number of tests that measure 3 or more biomarkers, by test source.

Cancer is an area that seems to be much better served by LDTs, at least in terms of diversity of test options. While only 5 panel-based tests for cancer have been cleared or approved by FDA in the last decade, Quest alone offers 23 such tests.

We will provide more detail on the total number of LDTs offered by leading labs, and the diversity of novel targets, in future posts.