11:38 AM
Mar 13, 2019
 |  BC Extra  |  Company News

FDA qualifies first biomarker test for brain injury

FDA said Tuesday it has qualified a biomarker test tool for use in clinical development of medical devices to treat traumatic brain injury. Developed by the University of California San Francisco’s TBI Endpoints Development Initiative, the OsiriX CDE software module is qualified for use in identifying patients for enrollment in clinical device trials to improve outcomes in patients with mild TBI.

OsiriX CDE provides a standardized tool to mark and classify brain contusions using common criteria and to label abnormalities in MRI scans.

OsiriX CDE is the first biomarker test tool qualified by FDA and the third FDA qualified medical device development tool (MDDT). The agency’s MDDT program is designed to help minimize the use of animal studies and either reduce the duration or enrollment size of clinical trials through optimized patient selection or more sensitive benefit and risk measurements.

In December, FDA issued draft guidance with an evidentiary framework for biomarker qualification in the context of drug development, which could encourage developers to submit biomarkers for qualification and expand opportunities for biomarker-guided clinical trials (see "Biomarkers' Road Less Traveled").

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