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Agena Bioscience announces FDA clearance of IMPACT Dx Factor V Leiden and Factor II genotyping test

Agena Bioscience, which recently acquired the Bioscience business of Sequenom, was notified by Sequenom that it received premarket clearance from the US Food and Drug Administration (FDA) for the 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. The test is intended for in vitro diagnostic use in a clinical laboratory setting.

Agena Bioscience chairman and interim CEO John Lillig said that the clearance of our IMPACT Dx Factor V Leiden and Factor II Genotyping Test on the IMPACT Dx system is a tremendous achievement that we believe contributes significant value to our business and represents the transition of the company’s proven research-use-only MassARRAY® System into the clinical diagnostics arena.

"We are also looking forward to CE marking the IMPACT Dx Combined Function System in the European Unionm," Lillig added.

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is performed using the IMPACT Dx system, which uses matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry to interrogate nucleic acids. The IMPACT Dx system is designed for use with FDA-cleared or approved tests citing its use. Additional tests will be added to the menu over time.