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FDA nods seen as big boost for next-gen sequencing

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Nov. 27, 2013—The Food and Drug Administration’s recent move to allow marketing of Illumina‘s MiSeqDx system, the agency’s first ever approval of a high-throughput sequencing platform, should send a strong signal to clinical laboratories that the technology is ready for prime time, says an executive at the San Diego-based company.

“It is significant for the field,” says Greg Heath, senior vice president and general manager of Illumina’s diagnostics business. “By clearing it, it gives the community the confidence to use this platform in an improved way, so they can have more confidence in assays they’re developing as laboratory-developed tests.”

The FDA also cleared for marketing Illumina’s universal kit for use on the MiSeqDx. The kit includes library preparation reagents, sample index primers, and sequencing consumables that labs need to develop amplicon assays on the in vitro diagnostic platform. The agency based its decision to approve the Illumina platform and reagents on their accuracy across numerous genomic segments spanning 19 human chromosomes, as well as demonstrated precision and reproducibility across instruments, users, days, and reagent lots.

National Institutes of Health director Francis S. Collins, MD, PhD, and FDA commissioner Margaret A. Hamburg, MD, touted the news in a Nov. 19 perspective piece in The New England Journal of Medicine. With the next-gen platform, “clinicians can selectively look for an almost unlimited number of genetic changes that may be of medical significance,” they wrote. “Access to these data opens the door for the transformation of research, clinical care, and patient engagement.”

They cited improvements in cancer care and pharmacogenomics as two areas where such technology could make a major impact. The cost to sequence a genome has fallen from about $10 million in 2008 to about $10,000 today, according to the National Human Genome Research Institute.

The FDA also granted marketing authorization to Illumina’s MiSeqDx Cystic Fibrosis 139-Variant Assay, along with its MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. The approval process took about a year from start to finish, according to Illumina’s Heath. He would not disclose pricing information on the MiSeqDx system, but says that it will be sold at a “slight premium” to the research-use-only MiSeq platform.

Heath cites four areas as “low-hanging fruit” for the use of next-gen sequencing: reproductive genetics, cancer, tissue-typing for bone marrow and organ transplantation, and infectious disease.

“These are probably the four areas where we’ll see applications—depending on what the labs are doing—and will justify the instrumentation,” Heath adds.

“We’re getting the endorsement of the entire community to move forward with this technology,” he says. “This is a very versatile tool that all labs will use in the not too distant future.”

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