Sensitive Marker Detects Chronic and Acute Kidney Disease

It is a protein strongly expressed in kidneys to protect against tubular damage caused by stress conditions such as nephrotoxic insults and ischemia.

Laboratory diagnosis of kidney disease depends largely on surrogate markers of kidney function rather than 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 the injury is substantial enough to compromise the renal function.

Urinary albumin is recognized as a marker of kidney damage. However, patients with microalbuminuria can have advanced renal pathology for which therapy is less effective than in earlier stages of the disease. There is a need for earlier detection of kidney injury and for therapeutic interventions at a time when kidney damage is limitable or reversible.

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.

Roche (Basel, Switzerland) and CMIC Co., Ltd. (Tokyo, Japan) announced that the two companies signed 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. "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.

CMIC provides services that contribute to the implementation of clinical trials. CMIC supports pharmaceutical companies in carrying out their core processes of drug development, manufacturing, and marketing. In 2007, the company was presented the 2007 Frost & Sullivan best practice award for competitive strategy leadership award in the Japanese contract research organization market

Roche is a leader in research-focused healthcare with combined strengths in diagnostics and pharmaceutics. The company produces differentiated medicines in oncology, virology, inflammation, metabolism, and the central nervous system (CNS). It is a leader in in-vitro diagnostics, tissue-based cancer diagnostics, and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.

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