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Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests—Preliminary Discussion Paper I. Overview Next generation sequencing (NGS)1 comprises a collection of new technologies that allow ra
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Company

In Vitro Diagnostics / Clinical Laboratory / NGS / /

Facility

Standards Institute / Clinical Laboratory / /

IndustryTerm

stand-alone software / healthcare system / manufacturing / healthcare professional / learning health systems / computational processing / /

MedicalCondition

Illumina MiSeqDxTM Cystic Fibrosis / disease / Illumina cystic fibrosis / relevant disease / NGS-based cystic fibrosis / diseases / particular diseases / cystic fibrosis / fibrosis / /

Organization

National Institute of Health / FDA / Clinical Laboratory and Standards Institute / Standards Institute / Standards Development Organization / /

Position

representative / /

Technology

genomics / Diagnostic Tests / DNA sequencing / SNP / human genome / /

URL

www.cftr2.org / http /

SocialTag