AWARD-WINNING GEM® PREMIER™ 7000 with iQM®3 EXPANDS COMMERCIALIZATION TO EUROPE

BEDFORD, Mass., July 29, 2025 /PRNewswire/ -- 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 and recognition in the US and Canada, the system is now available 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 seen tremendous success in North America, where it has been embraced by clinicians and honored with several prestigious awards," said Remo Tazzi, Vice President of Worldwide Marketing and Service at Werfen. "By expanding 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 delivering a complete menu of results, including: pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2).

Despite its prevalence throughout different areas of the hospital, hemolysis is 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%.2 In samples impacted by hemolysis, low potassium levels can appear normal and 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 Innovation
The GEM Premier 7000 with iQM3 has received six major awards, 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 Premier 7000 for its pioneering integration of hemolysis detection and its potential to transform point-of-care diagnostics.
  
  
• 2024 Medical Device Network Excellence Awards (3):
  • Innovation Award—For being the first system to integrate hemolysis detection, improving diagnostic accuracy.
  • Research & Development Award—Honoring its advanced features, including the all-in-one GEM PAK™ cartridge and continuous quality management.
  • Product Launch Award—Celebrating its successful US market introduction and its impact on efficiency and patient care.
    
    
• 2024 R&D 100 Award
  This 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 Award
  Presented by one of North America's largest integrated delivery networks, this award recognizes the GEM Premier 7000 for its lab- quality hemolysis detection at the point of care and its contribution to supporting accurate results and streamlined workflows.

These accolades demonstrate Werfen's commitment to advancing Specialized 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 & Laboratory Medicine (ADLM) Annual Meeting to share more information about 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.

About Werfen's Acute Care Diagnostics Portfolio

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 portable CO-Oximeter, simplify POC operations by automating key labor- 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

1. Lippi G, Salvagno GL, Favaloro EJ, Guidi GC. Survey on the prevalence of hemolytic specimens in an academic hospital according to collection facility: opportunities for quality improvement. Clin Chem Lab Med. 2009;47(5):616–618. doi:10.1515/CCLM.2009.132.
2. Lippi G, Plebani M, Di Somma S, Cervellin G. Hemolyzed specimens: a major challenge for emergency departments and clinical laboratories. Crit Rev Clin Lab Sci. 2011;48(3):143–153. doi:10.3109/10408363.2011.600228.
3. O'Hara M, Wheatley EG, Kazmierczak SC. The impact of undetected in vitro hemolysis or sample contamination 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.
4. Phelan MP, Ramos C, Walker LE, et al. The hidden cost of hemolyzed blood samples in the emergency department. J Appl Lab Med. 2021;6(6):1607–1610. doi:10.1093/jalm/jfab035.
5. Phelan MP, Hustey FM, Good DM, Reineks EZ. Seeing red: blood sample hemolysis is associated with prolonged emergency department throughput. J Appl Lab Med. 2020;5(4):732–737. doi:10.1093/jalm/jfaa073.
6. Wilson M, Adelman S, Maitre JB, et al. Accuracy of hemolyzed potassium levels in the emergency department. West J Emerg Med. 2020;21(6):272– 275. doi:10.5811/westjem.2020.8.46812.
7. Milutinović D, Andrijević I, Ličina M, Andrijević L. Confidence level in venipuncture and knowledge on causes of 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, and data management solutions for use primarily in 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.
The Hemostasis portfolio includes ACL TOP^® Family 50 Series and ACL TOP Family Hemostasis Testing Systems, ACL AcuStar^® system, ACL Elite^® systems, HemoCell™ Specialized Lab Automation, HemoHub™ Intelligent Data 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 Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.

SOURCE Werfen