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Statements posted on this blog represent the views of individual authors and do not necessarily represent the views of the Center for Law Science & Innovation (which does not take positions on policy issues) or of the Sandra Day O'Connor College of Law or Arizona State University.

FDA Moves on Regulation of Medical Laboratory Tests

The U.S. Food and Drug Administration (FDA) recently authorized a new laboratory developed test (LDT) for genetically profiling tumors. This test uses next generation sequencing (NGS) to help doctors develop strategic treatment plans for cancer patients.

The FDA traditionally did not provide oversight of LDTs, which are developed and administered by doctors in laboratories. Rather, the FDA focused its oversight efforts on in vitro diagnostic (IVD) test kits, which are sold to laboratories or directly to customers for use in the home.

This latest authorization may indicate that the FDA plans to move forward with its previously announced plan to ramp up oversight of LTDs.

Faculty Fellow Dr. Roger D. Klein believes that the FDA’s plan to regulate LTDs would be a mistake. He argues that LTDs provide doctors with safe and useful tests that can be modified quickly in response to the latest medical advancements. As he wrote recently in Investor’s Business Daily, the FDA risks stifling a useful tool:

The FDA approval process for these tests is lengthy and expensive. Obtaining approval for updates that keep tests current with rapidly advancing medical and scientific knowledge can be difficult and costly. Unsurprisingly, there are few genetic and genomic IVDs.

Dr. Klein recommends instead that the FDA focus on “operational safety issues,” and leave the medicine to the doctors. You can read Dr. Klein’s full commentary here: Fixing How FDA Regulates Diagnostic Lab Tests.