FDA Approves First Next-Generation DNA Sequencing Platforms

Article preview from "The Gray Sheet"- November 25, 2013

Illumina’s MiSeqDx instrument and MiSeqDx Universal Kit, granted de novo approval, allow clinicians to “develop and validate sequencing of any part of a patient’s genome,” FDA says.

FDA Approves First Next-Generation DNA Sequencing Platforms

Article preview from "The Gray Sheet"- November 25, 2013

High-throughput, next-generation DNA sequencing (NGS) devices received their first regulatory clearances from FDA Nov. 19 when the agency granted de novo approvals to two nondisease-specific diagnostic platforms made by Illumina Inc.

Illumina’s MiSeqDxPlatform instrumentation and MiSeqDx Universal Kit 1.0 allow clinicians to “develop and validate sequencing of any part of a patient’s genome,” FDA said in announcing the precedent-setting decision. The kit reagents isolate and create replicas of the genes obtained via blood samples, and the MiSeqDx instrument analyzes the genes.

“This MiSeqDx system is designed to deliver qualitative (i.e. genotype) results,” says FDA’s decision summary for the kit.

The de novo orders classified the kit into class I and the instrument into class II. Both orders stated that Illumina was free to immediately market the products, subject to special controls outlined in the orders.

In addition, FDA granted 510(k) clearance to the MiSeqDx Cystic Fibrosis 139-Variant Assay and MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, which analyze the cystic fibrosis transmembrane conductance regulator gene.

“With the FDA clearance of the MiSeqDx, Illumina is providing clinicians and clinical laboratories with the tools needed to obtain comprehensive and reliable results from a DNA sequencing analyzer and enabling them to create and deploy NGS-based molecular diagnostic tests for cystic fibrosis and a wide range of other applications,” Greg Heath, senior general manager of Illumina’s diagnostics business, said in a Nov. 19 statement.

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