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Navigenics Inc.

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Latest From Navigenics Inc.

FDA, 23andMe Open Up Market Pathway For DTC Genetics

The Google-backed firm's carrier screening assay for a rare disease called Bloom syndrome is the first DTC genetic test to achieve sign off from FDA. More importantly, the marketing authority was awarded in a manner that could significantly streamline the path to market for future DTC carrier-screening assays.

Medical Device Regulation

FDA, 23andMe Open Up Market Pathway For DTC Genetics

The Google-backed firm's carrier screening assay for a rare disease called Bloom syndrome is the first DTC genetic test to achieve sign off from FDA. More importantly, the marketing authority was awarded in a manner that could significantly streamline the path to market for future DTC carrier-screening assays.

Medical Device Regulation

Trends In Diagnostics – 2012

Diagnostics industry trends include the increasing adoption of genomics in clinical testing and with it a focus on services and workflow more so than differentiated technology; a slowdown in M&A activity, partly to allow the digestion of assets acquired in 2010-11; and the ongoing uncertainties of regulation and reimbursement of high-value molecular tests.

Medical Device Regulation

Molecular Diagnostics M&A: Dormant But Not Done

The current crop of molecular diagnostics acquisitions – espcially those made by nontraditional buyers – must mature prior to the commencement of additional M&A activity. Historical data suggest this could occur starting in the 2014-2015 timeframe.

Medical Device Business Strategies
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