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T2 Biosystems

The CMS ruling follows the release of data showing strong performance of the test, including its ability to detect bloodstream pathogens missed by blood culture.

John McDonough announced he is moving into an executive chairman role and will step down as CEO. The firm has begun searching for a new CEO.

The firm said it has entered exclusive agreements for distribution of its products in Estonia, Greece, Ireland, Saudi Arabia, and South Africa.

The firm noted that its study showed strong performance data, including high sensitivity and high specificity, in providing results direct from blood.

Its product revenues were up 30 percent year over year, but research revenues decreased 89 percent. The firm posted $329,000 in grant contribution revenues.

The agreement covers the manufacture and supply of superparamagnetic particles. T2 Bio will be a non-exclusive reseller of the particles as part of its products.

The firm said it secured a record 14 new contracts of T2Dx instruments in the fourth quarter, which was at the high end of its guidance for the second half of 2018.

The firm said that the panel is expected to receive CE marking for commercial availability in Europe later this year.

A lack of attractive targets, high valuations, and a more attractive IPO market contributed to a 45 percent year-over-year decline in M&A.

During the year, the growing threat of antimicrobial resistance drove development and adoption of advanced diagnostic tests, including molecular testing.

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