When Illumina Inc. acquired the regulatory consulting firm Myraqa, a specialist in in vitro diagnostics, in July, the press release announcement characterized the deal as one that would bolster Illumina’s in-house capabilities for clinical readiness and help prepare for its next growth phase in regulated markets. That’s not surprising given the US Food and Drug Administration’s approval a year and a half ago of its MiSeq next-generation sequencer for clinical use. But the deal could also suggest Illumina is beginning to move along the path toward taking on clinical risk – that is, eventually advising physicians and patients, which would mean facing regulators directly.
Such a move – by Illumina, another life sciences tools firm, or an information specialist from the high-tech universe –...
