Industry Updates

July 31, 2014

New FDA guidance on laboratory developed test: “Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)”

» In light of expanded medical utility and increased patient risk, in addition to increased technologic complexity, the FDA is embarking on a path of increased LDT regulation

» industry-This regulatory framework will be phased in over the next decade, and a central feature will be the regulatory stratification of LDTs based on patient risk

Additional Resources

August 6, 2014

New FDA guidance on companion IVDs: “In Vitro Companion Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff”

» Recommends that an IVD companion test should be cleared contemporaneously with its target therapeutic product

» Encourages device developers to request meetings with FDA and the target therapeutic company

» Lays out guidelines for when the use of companion IVD would be essential or mandatory

» Specific regulatory pathway will be determined by level of risk presented to patients

Additional Resources


Current prognostics tests (excluding PraediCare Dx) for AML fall far short of clinical utility: “Resistance Prediction in AML”. Roland Walter. Leukemia, 2014.

“The AUC of a bootstrap-corrected multivariable model predicting this outcome was only 0.78, indicating only fair predictive ability. Removal of FLT3-ITD and NPM1 information only slightly decreased the AUC (0.76). Prediction of resistance, defined as primary refractoriness or short relapse-free survival, was even more difficult.”

Additional Resources