Agena Bioscience Announces FDA 510(k) Premarket Clearance of the IMPACT Dx(TM) Factor V Leiden and Factor II Genotyping Test on the IMPACT Dx(TM) System
IMPACT Dx(TM) Combined Function System Will Also Be Available in the European Union
SAN DIEGO, June 16, 2014 /PRNewswire/ — 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(TM) Factor V Leiden and Factor II Genotyping Test and the IMPACT Dx(TM) System. The IMPACT Dx(TM) Factor V Leiden and Factor II Genotyping Test is performed on the IMPACT Dx(TM) 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.
SOURCE Agena Bioscience, Inc.