FDA’s new Next Generation Sequencing Draft Guidance excludes RNA-Seq

from JDSupra Business Advisor by Gail Javitt –

The Food and Drug Administration has released a 25-page Draft Guidance document addressing FDA oversight of certain applications of Next Generation Sequencing (NGS)-based technology.  The Draft Guidance − “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-based In Vitro Diagnostics (IVDs) Used For Diagnosing Germline Diseases” − aims to “provide recommendations for designing, developing, and validating NGS-based tests for germline diseases that FDA believes are appropriate for use in providing a reasonable assurance of the analytical validity of such tests.”

Although FDA, as well as the National Institutes of Health (NIH), appears to view this guidance as necessary to advance President Barack Obama’s Precision Medicine Initiative, in trying to achieve this end, the Draft Guidance infuses additional regulatory uncertainty about the pathway for NGS-based technologies that could have the opposite effect.

The purported scope of the draft guidance is “NGS-based tests with a broad intended use for suspected germline diseases.”  The guidance in fact excludes from its scope the vast majority of current uses of NGS-based testing, specifically, stand-alone diagnostic testing, screening, microbial genome testing, risk prediction, cell-free DNA testing, fetal testing, pre-implantation embryo testing, tumor genome sequencing, RNA sequencing, or use as companion diagnostics. The Draft Guidance states that these applications are excluded because such tests “may have other analytical characteristics not addressed by the recommendations presented here.”

Source – JDSupra Business Advisor

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