Opinions Divided on Proposed FDA LDT Regulations

January 6, 2015
Opinions Divided on Proposed FDA LDT Regulations
FDA has concerns over the adequacy of the scientific evidence supporting the use of many laboratory developed tests. [Kasto/Fotolia]

Chris Anderson

If the tenor of the overflow crowd at November’s Association for Molecular Pathology (AMP) Annual Conference to hear FDA’s Alberto Gutierrez, Ph.D., is any indication, the agency’s move to tightly regulate laboratory developed tests (LDTs) faces an uphill battle to win over those who run the thousands of molecular pathology labs across the country. Dr. Gutierrez, director, office of in vitro diagnostics and radiological Health at FDA, noted the agency was legally provided with regulatory oversight of tests developed in labs in 1976. But based on the types of “homebrew” tests used at the time, the agency decided to exercise regulatory discretion regarding LDTs.

But things have shifted dramatically over the past 40 years as companion diagnostics have multiplied in number and molecular pathology labs now routinely search for specific genetic mutations and other markers to both identify specific subtypes of cancer and to suggest precision therapies.

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