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