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Home » Sequenom in Discussions with FDA on Premarket Application for Sequencing-Based Trisomy 21 Test

Sequenom in Discussions with FDA on Premarket Application for Sequencing-Based Trisomy 21 Test

Mar 16, 2011
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By Monica Heger

This story was originally posted March 9.

Sequenom is on track to launch its sequencing-based prenatal diagnostic test for trisomy 21, called SensiGene T21, as a laboratory-developed test by the end of 2011 or early 2012 and plans to file for premarket approval of the test with the US Food and Drug Administration by late 2012 or early 2013.

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