The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA Clears Illumina’s ‘Next-Gen Sequencing,’ Cystic Fibrosis Dx

Nov. 29, 2013

San Diego-based Illumina will begin filling orders for its high-throughput gene sequencing tests and two other diagnostics by the end of the year, following FDA 510(k) clearance of all four devices.

The agency called the clearances a major advance for personalized medicine. Used together, the Illumina MiSeqDx instrument platform and Illumina Universal Kit reagents will allow laboratories to sequence and validate any part of a patient’s DNA to look for abnormalities. They were cleared through the de novo process for novel devices that do not pose a high risk to patients, based on safety and efficacy performance “across numerous genomic segments spanning 19 human chromosomes,” the agency said.

CDRH Director Jeffrey Shuren called the clearance a win for personalized medicine and regulatory science. “Knowing the potential of next-generation sequencing to advance personalized medicine, FDA researched next-generation sequencers to understand how they work and their likely limitations,” he said. “By the time Illumina … walked in the door, FDA had the expertise and tools needed to timely review the submissions for the next-generation sequencers.”

The company’s two cystic fibrosis detection tools also garnered 510(k) clearance. The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay checks a patient’s gene sequence to determine what variant of cystic fibrosis he or she may have, while the Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay examines a large chunk of the patient’s cystic fibrosis gene to understand how it differs from a reference gene. To obtain clearance, Illumina submitted data on both diagnostics compared with human reference genomes.

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