Non-invasive Diagnostics for Liver Diseases

The Invention A new serum marker specific for liver disease has been discovered. The marker is the soluble form of the human asialoglycoprotein receptor (ASGPR). An ELISA assay was developed with specific monoclonal antibodies that confirmed the correlation between reduced soluble ASGPR levels and liver fibrosis, cirrhosis and carcinoma. The Need Currently there is no reliable serum marker for liver disease. Liver damage is commonly associated with alcoholism and hepatitis B and C infection, which is rapidly rising worldwide. Liver biopsies are the gold standard method for diagnosis of liver disease; hence the great need for a reliable non-invasive marker. Potential Applications Diagnosis and monitoring of:

· cirrhosis and fibrosis of the liver

· liver cancer

· success in treatment of liver fibrosis

· success in liver transplantations Advantages 1. Non-invasive

2. Reliable

3. Quantitative

4. Easy to perform with standard ELISA

5. May be performed with frozen samples Stage of Development The essential components for a non-invasive diagnostic kit for liver disease are in place. Monoclonal antibodies to soluble ASGPR have enabled development of an ELISA assay to measure serum levels of soluble ASGPR in patients and normal individuals. Recombinant soluble ASGPR was generated to validate the assay and quantitate soluble ASGPR levels in sera. The method has been tested on multiple samples from men and women of varying ages, confirming the constant level of expression of soluble ASGPR in the healthy population. It has also been used to analyze samples from patients with liver fibrosis, cirrhosis, and hepatocarcinoma indicating strong depletion of the marker compared to normal individuals. References Tolchinsky, S., M.H. Yuk, M. Ayalon, H.F. Lodish, and G.Z. Lederkremer, Membrane-bound versus secreted forms of human asialoglycoprotein receptor subunits - Role of a juxtamembrane pentapeptide. J Biol Chem, 1996. 271(24): p. 14496-14503.

Inventor(s): Gerardo Z. Lederkremer,

Type of Offer: Licensing

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