Agena Bioscience

Formerly Sequenom Bioscience

 

Agena Bioscience(原Sequenom Bioscience)公司MassARRAY 核酸質(zhì)譜技術(shù)平臺的臨床應(yīng)用版“IMPACT Dx™系統(tǒng)”于2014年6月16日獲得美國FDA認(rèn)證，可用于臨床分子診斷應(yīng)用，從而成為世界上第一臺，也是唯一一臺獲得FDA臨床認(rèn)證的核酸質(zhì)譜平臺。Agena Bioscience公司，于2014年5月30日收購了Sequenom公司的生命科學(xué)部。

萊頓第五凝血因子突變檢測試劑盒Factor V Leiden Assay;

第二凝血因子基因分型檢測試劑盒Factor II Genotyping Assay;

基于MassARRAY® 核酸質(zhì)譜技術(shù)的IMPACT Dx™系統(tǒng)獲得FDA認(rèn)證是核酸質(zhì)譜技術(shù)由科研轉(zhuǎn)向臨床檢測的重大里程碑，預(yù)期其近期亦將獲得歐洲CE-IVD認(rèn)證。IMPACT Dx™系統(tǒng)所具有的超高靈敏度、精確度、準(zhǔn)確性、穩(wěn)定性、性價比的獨特優(yōu)勢，將幫助醫(yī)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.