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Roche. (1/12/10). "Press Release: Roche Announces Agreement with CMIC Co., Ltd. for Liver-type Fatty Acid Binding Protein (L-FAB) Diagnostic Test". Rotkreuz.

Region Region ALL
Organisations Organisation Roche Diagnostics (Group Division)
  Group Roche (Group)
  Organisation 2 CMIC Ltd.
  Group CMIC (Group)
Products Product diagnostic test, indication
  Product 2 biomarker
Index terms Index term license
  Index term 2 kidney
Persons Person Creeden, James (Roche 200901 Medical Director Roche Professional Diagnostics)
  Person 2 Ehlers, Dirk Horst (Roche 200812 Head of Roche Professional Diagnostics before Evotec OAI)
     
Roche and CMIC Co., Ltd. (Japan) today announced the signing of a license agreement which provides Roche with worldwide rights for patents related to the use of Liver-Type Fatty Acid Binding Protein (L-FABP) to detect kidney injury and disease.

Kidney disease constitutes a large and growing problem with increasing incidence in the ageing population. Chronic kidney disease often coexists with hypertension and diabetes and is recognized as a risk factor for cardiovascular disease. Acute kidney injury is a serious complication in hospitalized patients particularly in the critically ill. Laboratory diagnosis of kidney disease depends largely on surrogate markers of kidney function, not injury, such as serum Creatinine or Cystatin C. These markers reflect renal filtering capacity which is not sensitive to acute or chronic kidney injury unless injury is substantial enough to compromise the renal function. Urinary albumin is recognized as a marker of kidney damage. However, patients with microalbuminuria may have quite advanced renal pathology for which therapy is less effective than in earlier stages of the disease. There is a clear need for earlier detection of kidney injury and for therapeutic interventions at a time when kidney damage may be limitable or reversible.

Liver-type fatty acid binding protein (L-FABP), initially identified in hepatocytes, is a protein that is strongly expressed in kidneys to protect against tubular damage provoked in various stress conditions such as ischemia and nephrotoxic insults. Clinical studies have established L-FABP as a sensitive marker in both chronic and acute kidney disease. Urinary L-FABP increases within a few hours in patients with acute kidney injury and thereby earlier than conventional kidney function marker. Higher levels are found in patients with poor outcome and predict the need for renal replacement therapy. Furthermore elevated levels of L-FABP reflect the progression of chronic kidney disease such as diabetic nephropathy. Clinical studies indicate that L-FABP complements current kidney function tests and provides additional diagnostic information with regard to the localization and timing of kidney injury.

"We are convinced that L-FABP offers new opportunities to the early and accurate diagnosis of kidney damage and will contribute to informative diagnostic classification," said James Creeden, Head of Medical Affairs.

"Roche is committed to improve the diagnosis and treatment of kidney diseases. The development of this innovative marker will not only help in the clinical management of patients but will also support new research into therapies for kidney disease," said Dirk Ehlers, Head of Roche Professional Diagnostics.

About CMIC Co., Ltd.

As Japan's first contract research organization (CRO), CMIC provides services that contribute to the efficient, expeditious implementation of clinical trials. Utilizing its abundant experience, CMIC comprehensively supports pharmaceutical companies in carrying out their core processes of drug development, manufacturing and marketing. Contributing to the maximization of pharmaceutical company value, CMIC offers a broad lineup of services. For further details, please visit the CMIC website at http://www.cmic.co.jp/e/

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

   
Record changed: 2010-07-21

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