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FDA Approves First Next-Generation DNA Sequencing Platforms

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.

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...

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