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More Surely on the Way

The US Food and Drug Administration has cleared sequencing-based cystic fibrosis assays, the Wall Street Journal reports.

The tests, from Illumina, include the company's MiSeqDx Cystic Fibrosis 139-Variant Assay, which examines specific spots of the CFTR gene, and its Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, which sequences the CFTR gene and compares it to a reference, according to an FDA press release

"Before [next-generation sequencing], sequencing genes associated with a particular disease was a long and costly process," Alberto Gutierrez, the director of the Office of In Vitro Diagnostics and Radiological Health in FDA's Center for Devices and Radiological Health, says in a statement. "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."

Francis Collins, the director of the National Institutes of Health and a cystic fibrosis researcher, in a statement calls the approval of these tests "exciting," though he notes that there is still much work to be done.

He and Margaret Hamburg, the FDA commissioner, write in the New England Journal of Medicine that the clearance of a sequencing platform for use in the clinic will pave the way for genetic information to be more widely adopted by physicians in their care of patients.

However, they note that while some progress has been made, there remain policy, legal, and regulatory issues that need to be sorted out, and new findings must be validated. In addition, Collins and Hamburg write that doctors, healthcare workers, and patients will need support and help in understanding genomic data.

"The arrival of next-generation sequencing at this regulatory landmark is only the beginning," they add. "We need to work together to ensure that research progresses, that regulatory policies are developed, that patients' rights and needs are addressed, and that clinical use of genomic information is based on rigorous evidence."

GenomeWeb Daily News has more on the premarket clearance of the assays here.

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