Patent ID: 7833728

Claim:
A method of monitoring the status of a hypoxic condition or cancerous disease associated with hypoxia in a patient, wherein said condition or disease is associated with abnormal expression of CA IX, and/or of monitoring how said condition or disease in a patient is responding to a therapy, comprising immunologically detecting and quantifying serial changes in soluble CA IX levels in samples of a body fluid taken from said patient over time, said method comprising the steps of: (a) contacting a body fluid sample from said patient with at least two antibodies and/or antibody fragments which specifically bind to soluble CA IX, wherein at least one of said antibodies and/or antibody fragments specifically binds a non-immunodominant epitope of CA IX's extracellular domain; (b) detecting and quantifying the level of soluble CA IX in the sample by detecting and quantifying binding of said antibodies and/or said antibody fragments in said sample; and (c) monitoring serial changes in the level of soluble CA IX in additional samples from the said patient taken over time, wherein increasing levels of soluble CA IX in the samples over time indicate the status of the condition or disease is unchanged and/or said condition or disease is not responding to said therapy, and wherein decreasing levels of soluble CA IX in the samples over time indicate condition or disease remission and/or that said condition or disease is responding to said therapy; wherein said soluble CA IX is a protein having an amino acid sequence from or of SEQ ID NO: 5, or a protein having an amino acid sequence from or of CA IX's extracellular domain, wherein CA IX is encoded by a nucleotide sequence selected from: i) SEQ ID NO: 1; ii) nucleotide sequences which hybridize under stringent hybridization conditions of 0.02 M to 0.15 M NaCl at temperatures of 50° C. to 70° C. to the complement of SEQ ID NO: 1; and iii) nucleotide sequences that differ from SEQ ID NO: 1 due to the degeneracy of the genetic code; wherein said soluble CA IX has a molecular weight of from about 15 kilodaltons to about 54 kilodaltons; wherein said soluble CA IX is specifically bound by the V/10 monoclonal antibody that is secreted from the hybridoma V/10-VU, which was deposited under the Budapest Treaty at the International Depository Authority of the Belgian Coordinated Collection of Microorganisms (BCCM) at the Laboratorium voor Moleculaire Biologie-Plasmidencollectie (LMBP) at the Universeit Gent in Gent, Belgium, under Accession No. LMBP 6009CB.