Policy
Policy
Next-Generation Sequencing
Background
Next-generation sequencing (NGS) is a powerful new technology capable of examining millions of DNA variants at a time to inform treatment decisions and detect variations that may cause disease or elevate the risk for disease.
PMC has been at the forefront of discussions surrounding regulatory oversight of these technologies since 2015 and continues to engage on the topic.
2015
Optimizing FDA's Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests — Preliminary Discussion Paper
- PMC Comment Letter (PDF)
March 20, 2015