A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.
FDA Draft Guidance on Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
An in vitro companion diagnostic device (hereafter referred to as an “IVD companion diagnostic”) is an in vitro diagnostic device1 122 (IVD) that provides information that is essential for the safe and effective use of a corresponding therapeutic product.2 123 As described in the FDA guidance entitled “In Vitro Companion Diagnostic Devices.
New FDA guidance on laboratory developed test: “Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)”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.
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.