Agena Bioscience Announces FDA 510(k) Premarket Clearance of the IMPACT Dx™ Factor V Leiden and Factor II Genotyping Test on

 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

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

PR Newswire

SAN DIEGO, June 16, 2014

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™ 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 is a San Diego, CA based life sciences and clinical
diagnostics company that offers 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.

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

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SOURCE Agena Bioscience, Inc.

Website: http://www.agenabioscience.com
Contact: Fritz Eibel, Head of Commercial Operations, Agena Biosciences, Office
858.242.1720, Cell Phone 858.353.7567, Fritz.Eibel@AgenaBio.com
 
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