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Companies That Entered The Biomarker-Based IVD Market For The First Time During 2013

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Six companies had their first biomarker-based tests cleared by FDA in 2013, and while they (and the tests they released) were quite diverse in many respects, company size is not one of them. Philips Healthcare is the one large company represented, and the remaining five have less than 300 employees on LinkedIn (and three have 50 employees or less on LinkedIn).

It makes sense that new market entrants would tend to be smaller, but these small players are also key sources of innovation. NanoString brought one of the first multiplex panels to the IVD market in 2013, and introduced 45 new biomarker targets to the market in the process.

Rapid Pathogen Screening brought another novel biomarker target to the IVD market with MMP-9, and the only other novel target to come to market in 2013 was EGR1, released in a test by Abbott.

This table lists all of the companies that had biomarker-based tests cleared by FDA during 2013, along with the test details and country of origin.
This table lists all of the companies that had their first biomarker-based tests cleared by FDA during 2013, along with the test details and country of origin.

Companies from five different countries on three continents had biomarker tests cleared during 2013. Fifty-four different biomarker targets are used in all in these tests, and tests for diagnostic, prognostic, and companion diagnostic indications were all released.

It is encouraging to see Philips making its first foray into biomarker-based tests, and it will be interesting to see if more will follow.