The Food and Drug Administration has allowed marketing efforts to begin for four diagnostic devices that can be used for throughput, or "next generation," gene sequencing.
The new technology allows labs to sequence a patient's DNA and gives physicians the ability to analyze their patients' genetic makeup, potentially aiding in diagnosing disease or identifying root causes of symptoms.
"NGS is changing the way we look at genomics," said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, in a news release. "Before NGS, sequencing genes associated with a particular disease was a long and costly process. Today, we have the capability to read and interpret large segments of DNA very quickly in a single test, and this information-rich technology is becoming more accessible for use by physicians in the care of their patients."
Cleared technology includes the Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay, the Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, the Illumina MiSeqDx instrument platform and the Illumina Universal Kit.
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