Regulating laboratory-developed tests.

Disclaimer: The views expressed in this editorial are solely those of the author and should not be construed as reflecting the views of the Department of Veterans Affairs or the United States Government. As a molecular pathologist for more than 20 years, I have had the opportunity to develop laboratory tests and to assess the efforts of others to develop laboratory tests. As Editor of The Journal of Molecular Diagnostics for 5 years, I have had the privilege and responsibility to review a wider range of developments by laboratories and manufacturers alike. In my work with the US government, including two stints at the US Food and Drug Administration (FDA), I’ve been witness to the means by which laboratories and manufacturers alike draw conclusions from their data. After all of this, I cannot conclude that either laboratories or manufacturers invariably report conclusions that are supported by their data using statistically valid techniques based on unbiased and appropriate experimental design. I’ve also come to recognize that regulatory activities often fail to accurately and effectively identify important systemic problems and that lack of adequate coordination among agencies creates confusion, increases burden on the general public, may increase the costs of providing medical services (thus increasing taxpayer burden), and has the potential of paradoxically and negatively influencing public health outcomes. In light of my personal experience, this Editorial discusses some of the issues raised by the FDA’s proposed framework for regulating laboratory developed tests (LDTs).