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# Sequencing Guidance Raises Questions: Attorney
- URL: https://www.fdaweb.com/sequencing-guidance-raises-questions-attorney/
- Published: 2016-07-26T12:00:00.000Z
- Updated: 2026-09-14T21:18:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136282

Attorney **Gail Javitt** (DLA Piper) says that a recent FDA draft guidance on agency oversight of certain applications of next generation sequencing (NGS)-based technology leaves several threshold questions unanswered. Writing in an online [post](https://www.dlapiper.com/en/us/insights/publications/2016/07/fdas-new-next-generation-sequencing-draft/?utm%5Fsource=TWITTER), Javitt says that the standards proposed in the guidance address areas including test design considerations, test performance characteristics, performance evaluation, variant annotation and filtering, and test reports.

Questions that remain unanswered, it says, include: 

- Which tests will be subject to the recommendations?
- To what entities will the recommended standards apply, for example, instrument developers, clinical laboratories, algorithm developers?
- Is the guidance scope actually limited to analytical validity considerations, as FDA says, or does it actually encompass the clinical validity of using test results in a patient treatment context?
- Will FDA require premarket review for NGS-based tests and if so, what type of review and approval?