IVD manufacturers often introduce their newest technologies in Europe before the United States

DATELINE: BERLIN, GERMANY: With so many changes happening to clinical pathology laboratory testing in developed nations around the world, there is keen interest in evolving technologies, along with new medical laboratory instruments and automation products that clinical biochemists and pathologists will use, in the near future, to improve the quality of the clinical laboratory testing services they provide to physicians.

Here at the IFCC-WorldLab Berlin 2011 conference, pathologists and clinical chemists from the United States got an early peek at some of the latest and newest solutions developed by the world’s largest in vitro diagnostics (IVD) manufacturers. Many products on display at the IFCC WorldLab Exhibition have only been cleared for sale by the European Union. These products do not have clearance by the U.S. Food and Drug Administration (FDA) in the United States for sale and use in this country.

New Technologies for Medical Laboratories

It means these “latest generation” medical laboratory analyzers, automated systems, and diagnostic test kits being shown at the IFCC-WorldLab exhibition are not available for purchase and use by clinical laboratories and pathology groups in the United States. This situation has existed for almost two decades. It happens because IVD manufacturers find it easier, faster, and less expensive to gain market clearance for their latest-generation products in the European Union. Thus, medical laboratories in Europe generally can purchase these advanced lab testing solutions months and years before the same products become available in the United States.

One example of a “next generation” automated medical laboratory testing system that was introduced this week at the IFCC-WorldLab Berlin 2011 conference is a new hematology testing system manufactured by Sysmex Corporation.

It is called the “XN Series” and is distributed by Sysmex Europe. Your Dark Daily Editor was in Berlin to provide the keynote address to a gathering of hundreds of Sysmex medical laboratory clients. During these evening sessions, Sysmex unveiled this “next generation” automated hematology testing system. That gave your Editor the opportunity to interview several of the Sysmex Europe executives about the specific advances and improvements that were engineered into this new product line.

During these interviews, Matthias Völkel, Managing Director of Sysmex Europe Gmbh, called attention to three specific features. “Each year, medical laboratories demand improved performance from the analyzers and automated systems they acquire and use,” stated Völkel. “Streamlined workflow is one example. Another is improved accuracy and analytical precision for the assays performed on these analyzers. Thus, my answer to your question would emphasize three characteristics that we have engineered into this new XN-series.

  • “First, even our standard system is designed to be modular,” he noted. “This gives labs the flexibility to match specific needs for test menu and volume in a very precise way. Then, as the needs of that medical laboratory change, this standard system can be easily reconfigured to expand both the number of tests and the volume capacity.
  • “Second, with more clinical laboratories adopting process improvement and work flow redesign methods, our XN-series has been engineered to support streamlined workflow,” continued Völkel. “This new system is scalable to accommodate the customized needs of each laboratory. Work load can be easily balanced and we have integrated the capabilities of this system within a compact footprint, since space in the laboratory is now at a premium.
  • “Third, ever-increasing demand in legal and workflow requirements for laboratories are the reasons why this hematology system has on-board solutions that standardize sample and data flow management and documentation,” concluded Völkel.

IVD Firms under Pressure to Deliver Better Solutions to Medical Labs

Dark Daily observes that the three performance characteristics that Völkel chose to highlight reflect the new reality in the clinical laboratory testing marketplace. Customers of Sysmex and the biggest IVD manufacturers, including Roche Diagnostics, Siemens Diagnostics, Abbott Laboratories, and Beckman Coulter, to name a few, want more performance for a reduced price.

At the International Federation of Clinical Chemistry and Laboratory Medicine meeting in Berlin, Germany, yesterday: Matthias Völkel, Managing Director of Sysmex Europe Gmbh (on the right) shows Dark Daily Editor Robert L. Michel the newest generation product line that Sysmex unveiled at IFCC. It is the XN series of hematology analyzers, which is cleared for sale in Europe, but which will not be available in the United States until FDA clearance is issued. That is expected within the next six to 12 months. (Photo by Dark Daily.)

It means the medical laboratories are tougher buyers today than they were just a few years ago. With budgets shrinking year after year—even as the volume of specimens to be tested increases—clinical laboratories must get more value for their money when they buy new analyzers and total laboratory automation solutions (TLA).

Another capability that IVD manufactures will need to engineer into their products is the ability to support laboratory workflow that incorporates Lean and rapid process improvement. Along with this function, new clinical laboratory systems will need to support improved documentation requirements and give medical laboratory managers real time dashboards that help them manage all aspects of workflow in the laboratory.

These are significant market trends. Pathologists and clinical laboratory managers in the United States and other developed countries should expect to see all first-rank IVD manufacturers incorporate similar functions and capabilities in their products going forward. It may be that, in coming years, medical laboratories may be able to get more for their money when they acquire and use new analyzers and automated systems.

In an upcoming Dark Daily e-briefing, your Editor will share other impressions and insights gained from his attendance at IFCC-WorldLab 2011, which is produced by the International Federation of Clinical Chemistry and Laboratory Medicine.

Your Dark Daily Editor,

Robert L. Michel
e-mail: rmichel@darkreport.com with your comments.

Related Information:

Word from the IFCC President Graham Beastall

Sysmex Launches the XN Series of Flagship Models in the Hematology Field

For a peek at the Sysmex XN-Series product line, which is not currently available for sale and use in the United States