The laboratory industry has provided a strong, rational response to FDA’s draft guidance on LDT regulation. Molecular testing in oncology and the test case of colorectal cancer provides the foundation for a sound argument against the FDA model of regulating LDTs as devices and for the proposal for modular regulation of LDTs as “In Vitro Clinical Tests” put forth by the Diagnostic Test Working Group.
Reagent kit manufacturers such as TrimGen have developed technology to allow simultaneous detection of all mutations in a given codon. Laboratories can use these reagents to develop their own LDTs, demonstrate their analytical specificity and sensitivity, and quickly provide the depth of analysis required by the latest NCCN guidelines.
As of this year, colon cancer is the second leading cause of cancer-related deaths in the United States. The best way to improve this statistic is to ensure patients receive the best in molecular diagnostics and prognostics, and that they quickly receive the treatment most appropriate to them. The rapid turnaround enabled by forward-thinking reagent manufacturers and laboratorians is the best answer to this need.