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Agena Bioscience, Inc.. (6/16/14). "Press Release: Agena Bioscience Announces FDA 510(k) Premarket Clearance of the IMPACT Dx Factor V Leiden and Factor II Genotyping Test on the IMPACT Dx System". San Diego, CA.

Region Region United States (USA)
Organisations Organisation Agena Bioscience Inc.
  Group Agena Bioscience (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product ImpactDx™ Factor V Leiden and Factor II Genotyping Test
  Product 2 ImpactDx™ system
Person Person Lillig, John (IRORI Technologies 201311– CEO before Brooks Life Science Systems + Nexus Biosystems)
     


IMPACT Dx™ Combined Function System Will Also Be Available in the European Union


Agena Bioscience, Inc., which recently acquired the Bioscience business of Sequenom, Inc., was notified today by Sequenom, Inc. that it received premarket clearance from the U.S. 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.

The Factor V Leiden mutation increases risk of venous thromboembolism seven-fold (when heterozygous) to 80-fold (when homozygous). Individuals heterozygous for the Factor II prothrombin mutation have 25% higher plasma prothrombin levels than individuals with wild type genotype, and a 2.8-fold increased risk of venous thromboembolism.

“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 our proven research-use-only MassARRAY® System into the clinical diagnostics arena,” said John Lillig, Chairman and interim CEO of Agena Bioscience. “We are also looking forward to CE marking the IMPACT Dx Combined Function System in the European Union.”

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.

For more information on the IMPACT Dx Factor V Leiden and Factor II Genotyping Test on the IMPACT Dx System, visit www.agenabioscience.com/clinical-diagnostics.


About Agena Bioscience

Agena Bioscience is a San Diego, CA based life sciences and clinical diagnostics company that recently acquired the Bioscience business of Sequenom, Inc. and is now offering the MassARRAY® System. The system is a highly sensitive, quantitative method for nucleic acid detection via MALDI-TOF mass spectrometry for high-throughput genotyping and mutation profiling for cancer and other disease research, companion diagnostics, pharmacogenomics, epigenetics, clinical genetics, ag-bio genetics, and biobanking molecular sample identification.

www.agenabioscience.com

Note: The MassARRAY System, MassARRAY Analyzer 4, Hemo ID Blood Group Genotyping Panel, iPLEX Gold, iSEQ, QGE, EpiTYPER, TYPER software, MelaCarta Panel, OncoCarta Panel, LungCarta Panel, LungFUSION Assays by Agena (AbA) Panel, iPLEX ADME PGx Pro Panel, Assays by Agena Bioscience Oligo Sets, UltraSEEK Oncogene Panel, OncoFOCUS Panel, SpectroCHIP Array, iPLEX Pro Sample ID Panel, Assay Design Suite Software and Assay Explorer are for Research Use Only. Not for use in diagnostic procedures.

   
Record changed: 2016-01-10

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