Illumina Inc has acquired Myraqa, a regulatory and quality consulting firm specializing in in vitro diagnostics, with emphasis on companion diagnostics.
Led by founder and CEO Mya Thomae, Myraqa focuses on regulatory strategy and application support, including presubmission filings, investigational device exemptions (IDEs), premarket notifications (510(k)s), de novo 510(k)s, premarket approvals (PMAs), and EU technical files. The acquisition will bolster Illumina’s in-house capabilities for clinical readiness and help prepare for its next growth phase in regulated markets.
“Under Mya Thomae, Myraqa is recognized as the leader in regulatory and quality matters in molecular diagnostics,” said Rick Klausner, MD, chief medical officer at Illumina. “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. Mya will lead Illumina’s regulatory strategy and execution, providing us with a world-class regulatory organization, and is part of our commitment to making Illumina a preeminent clinical company.”
“Illumina is at the forefront of driving next-generation sequencing to the clinic, and I look forward to being a key part of this market transformation,” said Thomae. “Illumina exemplifies many of the values that have successfully guided Myraqa, and I’m excited for our team to share in this opportunity to shape the future of medicine.”
As part of Illumina, Myraqa’s team will continue to report to Thomae. Thomae will report to Illumina’s Klausner as the vice president of regulatory affairs. “We expect Mya and her team to complete existing programs and to continue to work with selected third parties on sequencing-based projects,” added Klausner.
Myraqa is based in Redwood Shores, Calif, and was founded in 1998. It comprises leading experts in regulatory, quality, clinical, biostatistics, and development.
The financial impact of the transaction was contemplated in Illumina’s 2014 financial guidance, released on April 22, 2014.
For further information, visit Illumina.