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US regulators approve next-generation sequencer for clinical use

The US Food and Drug Administration (FDA) has issued its first approval of a next-generation sequencing platform to be used for clinical diagnosis, the agency announced on 19 November.

The approval — eagerly awaited by researchers and industry — includes three diagnostic kits to be used with the MiSeqDx sequencer made by San Diego, California-based Illumina. Two of the tests are used to pinpoint genetic mutations in cystic fibrosis patients.  For such patients, the identity of the mutations they carry in a gene called CFTR can sometimes determine which medication is likely to work best.

The third is a ‘universal’ kit intended to allow clinical labs to develop their own tests on the MiSeqDx sequencer.

In a commentary in the New England Journal of Medicine, National Institutes of Health chief Francis Collins and FDA commissioner Margaret Hamburg praised the approval as opening the door to improved cancer diagnoses and pharmacogenomics — a field in which drugs are selected based on a patient’s genetic profile. But they also highlighted the challenges still confronting personalized medicine, including unresolved questions regarding insurance reimbursement, standards development, and physician and patient education.


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