Werfen today announced the expansion of commercialization for the GEM Premier 7000 with iQM3 blood gas testing system, following its success in North America. Building on strong clinical adoption andrecognition in theUSandCanada,thesystemisnowavailable in Europe.
The GEM Premier 7000 is the first and only blood gas testing system to integrate hemolysis detection at the point of care, addressing the most common preanalytical error in blood gas testing, accounting for up to 70% of all such errors.1 With results in just 45 seconds, the system empowers clinicians to make faster, more informed decisions.
“As a breakthrough in blood gas testing, the GEM Premier 7000 with iQM3 has seentremendoussuccess inNorthAmerica, whereithasbeenembraced by cliniciansandhonored with several prestigious awards,” said Remo Tazzi, VicePresidentofWorldwideMarketingandService atWerfen.”Byexpanding commercialization across Europe, this transformative solution will shine a light on the hidden problem of hemolysis, and advance care for many more patients.”
In just 45 seconds, the GEM Premier 7000 detects hemolysis, while deliveringacomplete menuofresults,including:pH,pCO2,pO2,sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2).
Despiteitsprevalencethroughoutdifferent areasof thehospital, hemolysisis not visible in whole blood and can go unrecognized. Hemolysis occurs when red blood cell membranes rupture, causing cellular contents to leak into the surrounding fluid, which can elevate potassium results up to 152%.2In samplesimpactedby hemolysis,low potassiumlevelscanappearnormaland normal levels can appear high. Consequences of in vitro hemolysis can include inappropriate patient management, longer length of stay, and increased costs, among others.3-7
Recognized for Excellence in InnovationTheGEMPremier7000withiQM3hasreceived sixmajorawards, underscoring its impact on diagnostic medicine:
— 2025 Edison Award-Silver Winner in Emergency and On-Site Health Solutions
— The Edison Awards honor excellence in innovation, recognizing the GEM Premier7000foritspioneeringintegrationofhemolysisdetection and its potential to transform point-of-care diagnostics.
— 2024 Medical Device Network Excellence Awards (3):
— Innovation Award-Forbeingthefirstsystem tointegrate hemolysis detection, improving diagnostic accuracy.
— Research & Development Award-Honoringitsadvanced features, including the all-in-one GEM PAK™ cartridge and continuous quality management.
— Product Launch Award-CelebratingitssuccessfulUSmarket introduction and its impact on efficiency and patient care.
— 2024 R&D 100 AwardThis award recognizes the GEM Premier 7000 as one of the 100 most technologically significant new products and technologies introduced in 2024. Highlighting groundbreaking advancements across various fields, this award is a mark of excellence in the scientific and technological community.
— 2025 Premier Inc. Supplier Innovation Celebration AwardPresented by one of North America's largest integrated delivery networks, this award recognizes the GEM Premier 7000 for its lab- qualityhemolysisdetectionatthepointof careanditscontributionto supporting accurate results and streamlined workflows.
These accolades demonstrate Werfen'scommitmenttoadvancingSpecialized Diagnostics through innovation, and delivering technologies designed to help enhance clinical workflows and power patient care.
Press Conference
A press conference will be held during the Association for Diagnostics & LaboratoryMedicine(ADLM)Annual Meetingtoshare moreinformationabout the GEM Premier 7000 with iQM3 and its commercialization. Time/Place: Wednesday, July 30, 2025, at 12 noon CT, Press Conference #2 Room s102d, McCormick Place Convention Center, Chicago, IL.
AboutWerfen'sAcuteCareDiagnosticsPortfolio
The GEM Premier 7000 with iQM3 system is part of Werfen's integrated and comprehensive ACD product portfolio-helping clinicians and laboratorians achieve better patient outcomes, lower total cost of care, assure accreditation compliance and improve operational efficiency in hospital acute care settings. For Whole Blood Hemostasis testing, ROTEM viscoelastic testing systems, the GEM Hemochron™ 100 system, and the VerifyNow™ platelet-reactivity testing system inform key clinical decisions regarding transfusion, bleeding risk and heparin dose adjustment during surgical and interventional procedures along with a clinical assessment of the patient's condition and other laboratory tests. For Blood Gas testing, the GEM Premier systems, including GEM Premier 7000, 5000 and 3500 systems, and the Avoximeter™1000 portableCO-Oximeter,simplifyPOCoperationsbyautomatingkeylabor- and skill-intensive tasks, including quality management and system maintenance. From Cardiovascular Operating Rooms and Catheterization Labs, to Intensive Care Units and Emergency Departments, whole-blood, cartridge-based systems with Werfen's integrated data management solutions, help hospitals improve efficiency and enhance patient care.
References
— LippiG,SalvagnoGL,FavaloroEJ,GuidiGC.Surveyontheprevalenceofhemolyticspecimens inanacademic hospital according to collection facility: opportunities for quality improvement. Clin Chem Lab Med. 2009;47(5):616-618. doi:10.1515/CCLM.2009.132.
— LippiG,PlebaniM,DiSommaS,Cervellin G.Hemolyzedspecimens:amajorchallenge foremergency departments and clinical laboratories. Crit Rev Clin Lab Sci. 2011;48(3):143-153. doi:10.3109/10408363.2011.600228.
— O'Hara M,WheatleyEG,KazmierczakSC.Theimpactofundetectedinvitrohemolysis orsamplecontamination on patient care and outcomes in point-of-care testing: a retrospective study. J Appl Lab Med. 2020;5(2):332-341.doi:10.1093/jalm/jfz020.
— PhelanMP,RamosC,WalkerLE,etal.Thehidden costofhemolyzed bloodsamplesintheemergency department. J Appl Lab Med. 2021;6(6):1607-1610. doi:10.1093/jalm/jfab035.
— PhelanMP,HusteyFM,GoodDM,ReineksEZ.Seeingred:bloodsamplehemolysisisassociatedwithprolonged emergency department throughput. J Appl Lab Med. 2020;5(4):732-737. doi:10.1093/jalm/jfaa073.
— Wilson M,AdelmanS,MaitreJB,etal.Accuracyofhemolyzed potassium levelsintheemergencydepartment.WestJEmerg Med.2020;21(6):272- 275. doi:10.5811/westjem.2020.8.46812.
— Milutinovic D,AndrijevicI,LicinaM,AndrijevicL.Confidence levelinvenipunctureandknowledge oncausesof in vitro hemolysis among healthcare professionals. Biochem Med. 2015;25(3):401-409. doi:10.11613/BM.2015.040.
Werfen (www.werfen.com), founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells,anddatamanagementsolutionsforuseprimarilyin hospitals and independent clinical laboratories. The Company's clinical areas of focus include Hemostasis, Acute Care, Transfusion, Autoimmunity, and Transplant. Werfen's Acute Care portfolio includes the new GEM Premier 7000 with iQM3, the GEM® Premier™ 5000 with iQM®2, GEM Premier 3500 system with iQM, GEM Premier ChemSTAT™ system, ROTEM®viscoelastic testing systems, Hemochron™ systems, VerifyNow™ platelet function testing system, and Avoximeter™1000 CO-Oximeter, GEMweb® Plus 500 Custom Connectivity and GEMweb Live.TheHemostasisportfolioincludesACLTOP®Family 50SeriesandACLTOPFamilyHemostasisTestingSystems, ACLAcuStar®system, ACLElite®systems, HemoCell™Specialized Lab Automation,HemoHub™IntelligentData Manager, along with the comprehensive line of HemosIL® assays.
The Werfen logo is a trademark of Werfen. GEM, Premier, GEM Premier ChemSTAT, GEMweb, iQM, ChemSTAT, HemosIL, ACL, ACL TOP, ACL Elite, ACL AcuStar, ReadiPlasTin, RecombiPlasTin, SynthASil, SynthAFax, ROTEM, Hemochron, VerifyNow and Avoximeter are trademarks of Instrumentation Laboratory Company, d.b.a Werfen, and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and TrademarkOfficeandinother jurisdictions.Allother product names,companynames, marks,logos,andsymbols are trademarks of their respective owners.
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