FDA Approves NGS Tests

The agency has cleared marketing of four next-generation sequencing devices from Illumina.

By | November 21, 2013

WIKIMEDIA, WEBRIDGEThe US Food and Drug Administration (FDA) yesterday (November 20) granted market approval for four diagnostic devices from Illumina based on next-generation sequencing (NGS). According to the agency, the San Diego-based firm is now free to market its MiSeqDx Cystic Fibrosis 139-Variant Assay and MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, both of which can detect aberrations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, for clinical use.

“NGS is changing the way we look at genomics,” Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, said in a statement. “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.”

In a New England Journal of Medicine commentary, FDA Commissioner Margaret Hamburg and National Institutes of Health Director Francis Collins noted the significance of these federal approvals for NGS. “The marketing authorization of a sequencing platform for clinical use will probably expand the incorporation of genetic information into health care,” they wrote.


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