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Sequenom's Failure Highlights an Underappreciated Risk of Biotech Investing

Executive Summary

Sequenom's late April announcement that the R&D data associated with its soon-to-be-launched test for Down syndrome "was mishandled by individuals in our company" sent a cold shiver throughout the biotech investment community. As if the biotech investment model wasn't risky enough, the firm had to go and introduce a new one.

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Top Device Stories of 2009: A Year of Economic Revival and Regulatory Risk

2009 was the most difficult year the device industry faced in a long time, particularly given the boom years that preceded it. Public and private investors grew nervous and sat on the sidelines, as did most corporate acquirers. As a result, most start-ups found it difficult to raise money and VCs were frustrated by the poor returns being generated, especially compared with the previously frothy climate. The silver lining may be that there are signs that the economic environment may be improving and that corporate acquirers will continue to pay a premium for the right deal. Overhanging all of this, however, is the specter of health care reform and its impact on the device industry, whether through a device tax, comparative effectiveness or some unanticipated other result, meaning the industry is far from out of the woods.

Top Device Stories of 2009: A Year of Economic Revival and Regulatory Risk

2009 was the most difficult year the device industry faced in a long time, particularly given the boom years that preceded it. Public and private investors grew nervous and sat on the sidelines, as did most corporate acquirers. As a result, most start-ups found it difficult to raise money and VCs were frustrated by the poor returns being generated, especially compared with the previously frothy climate. The silver lining may be that there are signs that the economic environment may be improving and that corporate acquirers will continue to pay a premium for the right deal. Overhanging all of this, however, is the specter of health care reform and its impact on the device industry, whether through a device tax, comparative effectiveness or some unanticipated other result, meaning the industry is far from out of the woods.

Noninvasive Prenatal Diagnostics: How Much Closer to Reality?

Whether the astonishing missteps by Sequenom, which earlier this year disclosed it could not support its data for a non-invasive Down Syndrome test, were merely poor management or a reality check for the field of non-invasive prenatal disgnostics, the NIPD opportunity is compelling. But the profession also understandably balks at obtaining information that is not then clinically actionable -- an issue that could further amplify in importance as technologies like microarrays and direct DNA sequencing increase become more prevalent.

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