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June 16, 2014
08:05 EDTSQNMSequenom receives FDA premarket clearance
Sequenom announced that it has received premarket 510k clearance from the FDA to market its IMPACT Dx Factor V Leiden and Factor II Genotyping Test and the IMPACT Dx System. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is performed on the IMPACT Dx System, and is indicated for use as an aid in the diagnosis of patients with suspected thrombophilia. As previously announced, Sequenom completed the sale of its Bioscience business segment to Agena Bioscience. As part of this sale, the Premarket 510k Notification will transfer to Agena Bioscience and Sequenom will receive $2M upon the achievement of this regulatory milestone.
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