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Strengthening its Regulatory Strategy Support, Illumina Buys Myraqa

NEW YORK (GenomeWeb) – Illumina today announced it has acquired regulatory and quality consulting firm Myraqa for an undisclosed amount.

Based in Redwood Shores, Calif., Myraqa was founded in 1998 and specializes in in vitro diagnostics, particularly companion diagnostics, and focuses on regulatory strategy and application support, including premarket approvals, pre-submissions, investigational device exemptions, 510(k)s, de novo 510(k)s, and European Union technical files, Illumina said.

The acquisition comes amid plans by Illumina to push into the clinical space and regulated markets. Earlier this year, the company launched the VeriSeq pre-implantation genetic screening test on the MiSeq platform. While it did not have to go through the US Food and Drug Administration clearance process to launch VeriSeq as a clinical test, because neither the FDA nor the EU regulates the preconception space, Illumina would need to gain regulatory clearance in certain other geographies, including China, to launch the test in those locations.

Also, Illumina has said that it is in the process of developing oncology panels for FDA clearance and that it plans to submit the Verifi non-invasive prenatal test to the FDA for in vitro diagnostic clearance on the HiSeq 2500 by the end of 2014.

The Myraqa acquisition "will bolster Illumina's in-house capabilities for clinical readiness and help prepare [the firm] for its next growth phase in regulated markets," Illumina said in a statement. Myraqa Founder and CEO Mya Thomae will become the vice president of regulatory affairs at Illumina and report to Illumina CMO Rick Klausner, who said that Myraqa will complete its existing programs and continue working with "selected third-parties" on sequencing-based projects.

"With Myraqa, Illumina will continue to pave the way for the use of genomic technology, including next-generation sequencing, in regulated markets while also driving standards for use in the clinic," Klausner said, adding Thomae "will lead Illumina's regulatory strategy and execution, providing us with a world-class regulatory organization … making Illumina a pre-eminent clinical company."

Illumina said that the impact of the deal was included in the 2014 guidance that the company provided in April in its first-quarter financial earnings announcement. At the time, it increased its 2014 guidance and said that revenues for the year were anticipated to grow 21 percent to 23 percent year over year, compared to its previous estimate of 15 percent to 17 percent growth.

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