Healthcare Industry News:  liver fibrosis 

Diagnostics Regulatory

 News Release - July 18, 2007

Siemens Medical Solutions Diagnostics Announces Enhanced Liver Fibrosis Test for Europe

The First CE Marked, Non Invasive Blood Test for liver fibrosis is Available Through iQur, Ltd

TARRYTOWN, N.Y. & SOUTHAMPTON, England--(HSMN NewsFeed)--Siemens Medical Solutions Diagnostics (www.usa.siemens.com/medical) today announced the availability of its Enhanced liver fibrosis (ELF)(TM) test, the first CE-marked, standardized non-invasive blood test for assessing the status of liver fibrosis*. The Siemens ELF test was first validated in an international multicenter cohort study and is now available through iQur, Ltd., Southampton, UK, as a testing service for patient management.

Chronic liver disease, resulting from alcoholic liver disease, fatty liver, or viral hepatitis, is increasingly recognized as a major cause of morbidity and mortality. Standard liver function tests do not accurately reflect the true extent of fibrotic damage or, in many cases, may detect it too late.

Fibrosis is a common outcome in chronic liver disease, with progression to cirrhosis accounting for thousands of deaths each year. Liver biopsies are routinely performed to assess liver damage (fibrosis) and to try to monitor the effectiveness of pharmaceutical drugs in tackling the disease. Performing a liver biopsy is a hazardous, expensive and painful experience for the patient and does not always provide accurate results because of difficulties in sampling and interpretation. Fibrosis is not evenly distributed throughout the liver and because such a small amount of biological material is sampled, 55 percent of 15mm biopsies may be misclassified. Larger biopsies can be performed but even with 25mm sections, 45 percent will be erroneous.

Because ELF uses a blood sample rather than a biopsy, it can be used routinely for the same patient and helps monitor progression of fibrosis in the patient's liver.

"The benefit of the Siemens ELF test is that it can be used repeatedly, with minimal patient discomfort, to monitor disease progression and response to therapy," said David Okrongly, senior vice president, Molecular Business Unit, Siemens Medical Solutions Diagnostics. "It's the first standardized laboratory method for assessment of liver fibrosis which requires only a simple sample of blood. We are delighted that iQur now offers this ELF test as an incremental service for physicians managing patients with chronic liver disease."

The ELF test combines three serum biomarkers which have been shown to correlate to the level of liver fibrosis assessed by liver biopsy. These biomarkers include:

  • Hyaluronic acid (HA)
  • Procollagen III amino terminal peptide (PIIINP)
  • Tissue inhibitor of metalloproteinase 1 (TIMP-1)

The algorithm measures each of these markers by immunoassay, to create an ELF score. Sampling for the ELF test can be performed in a physician's office or health center, avoiding the need for a patient to travel to a hospital.

About iQur

iQur® is a specialty pharmaceutical company at the forefront of international breakthroughs in the detection, treatment and monitoring of Hepatitis C and other liver diseases. Founded in 2003 by liver disease specialist Professor William Rosenberg, iQur is based in Southampton General Hospital, Southampton, UK and has a second therapeutics research office at the University of Leeds, UK. To discuss using the ELF Test in your healthcare center, contact Tanya Dominey, Diagnostics Operations - tanya.dominey@iqur.com. Further information about iQur can be found at www.iqur.com.

About Siemens Medical Solutions Diagnostics

Siemens Medical Solutions Diagnostics offers a broad portfolio of performance-driven diagnostic solutions that assist in the diagnosis, monitoring and management of disease. Products and services bring together the right balance of science, technology, and practicality across the healthcare continuum to empower medical professionals with the vital information they need to deliver better, more personalized healthcare to patients around the globe. Visit us at www.siemens.com/diagnostics.

About Siemens Medical Solutions

Siemens Medical Solutions of Siemens AG (NYSE:SI ) is one of the world's largest suppliers to the healthcare industry. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. Recent acquisitions in the area of in-vitro diagnostics - such as Diagnostic Products Corporation and Bayer Diagnostics - mark a significant milestone for Siemens as it becomes the first full service diagnostics company. Employing more than 41,000 people worldwide and operating in over 130 countries, Siemens Medical Solutions reported sales of 8.23 billion EUR, orders of 9.33 billion EUR and group profit of 1.06 billion EUR for fiscal 2006 (Sept. 30). Further information can be found by visiting www.usa.siemens.com/medical-pressroom.

* Not commercially available in the US


Source: Siemens Medical Solutions

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