Agena Bioscience

Formerly Sequenom Bioscience

 

Agena Bioscience(原Sequenom Bioscience)公司MassARRAY 核酸质谱技术平台的临床应用版“IMPACT Dx™系统”于2014年6月16日获得美国FDA认证，可用于临床分子诊断应用，从而成为世界上第一台，也是唯一一台获得FDA临床认证的核酸质谱平台。Agena Bioscience公司，于2014年5月30日收购了Sequenom公司的生命科学部。

莱顿第五凝血因子突变检测试剂盒Factor V Leiden Assay;

第二凝血因子基因分型检测试剂盒Factor II Genotyping Assay;

基于MassARRAY® 核酸质谱技术的IMPACT Dx™系统获得FDA认证是核酸质谱技术由科研转向临床检测的重大里程碑，预期其近期亦将获得欧洲CE-IVD认证。IMPACT Dx™系统所具有的超高灵敏度、精确度、准确性、稳定性、性价比的独特优势，将帮助医生造福更多患者。

 

San Diego, Calif., June 16, 2014 -- 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.

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.

Note:  The MassARRAY System, MassARRAY Analyzer 4, iPLEX Gold, iSEQ, QGE, EpiTYPER, TYPER software, MelaCarta Panel, OncoCarta Panel, LungCarta 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.