On Heels of Successful MiSeqDx Launch, Illumina Plans to Submit HiSeq 2500, NIPT Assay to FDA | GenomeWeb

Illumina said this week that it plans this year to submit for US Food and Drug Administration clearance its HiSeq 2500 platform coupled with Verinata Health's Verifi test for noninvasive prenatal fetal aneuploidy screening.

In a presentation at the JP Morgan Healthcare conference in San Francisco, President and CEO Jay Flatley said the company plans to file the instrument for clearance in 2014 and that the Verifi test would be the first assay. Clearance of the HiSeq 2500 would enable other third parties to submit their test on the system, he said.

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