Industry Updates

March 2019

New statement by the FDA on advancing precision medicine and facilitating oncology clinical trials

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December 2018

FDA guideline on Companion Diagnostics

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.

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July 2016

FDA Draft Guidance on Principles for Co-development of an In Vitro Companion Diagnostic Device with a Therapeutic Product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.

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New FDA guidance on laboratory developed test: “Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)”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

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August 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

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August 2014

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.

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