FDA Approves First Next-Generation DNA Sequencing Platforms
This article was originally published in The Pink Sheet Daily
Executive Summary
Illumina’s MiSeqDx instrument and MiSeqDx Universal Kit, granted de novo approval, allow clinicians to “develop and validate sequencing of any part of a patient’s genome,” FDA says.
You may also be interested in...
Lung Cancer “Master Protocol” Eyed As Paradigm-Changing Approach To Drug Development
The biomarker-driven, multi-arm, multi-drug registration trial is expected to get under way in March 2014 with five drugs from different sponsors. With the promise of greater speed and efficiency in patient enrollment and late-stage development, it is being viewed as a potential model for other cancer settings.
FDA’s Upcoming Drug/Diagnostic Co-Development Guidance Could Quickly Become Outdated
Tests that look for many markers at a time “may completely change” the paradigm for companion diagnostics, CDRH’s Elizabeth Mansfield says.
Lawmakers Press OMB To Release Lab-Developed Test Draft Guidance
In a letter to Office of Management and Budget director Sylvia Mathews, nine Democratic representatives urged the release of a draft guidance establishing an FDA oversight structure for laboratory-developed tests. FDA said more than a year ago that the documents were under administrative review.