Neogenix Oncology, Inc.

A review.The use of biomarkers for the diagnosis, prognosis, and monitoring of disease; as well as to guide the choice of therapeutic regimens is predicted to be one of the leading priorities in clin. practice.The sheer complexity of the human cell, including its growth and signaling pathways, has made one of the biggest challenges in the cancer field the identification and characterization of such biomarkers and their translation into informative and reproducible diagnostic/prognostic tests.The increasing amounts of data, generated by exptl. methods, challenges researchers to extract biol. applicable information.The authors, who represent academia, industry, and governmental organizations, discuss the current potential of translating cancer biomarker discoveries into suitable clin. tests.This review includes current information based on the latest patents in the cancer biomarker field relating to the different types of biomarkers (genomic, proteomics, epigenetics and microRNAs).It also describes the importance of strong intellectual property protection, current trends in patenting biomarkers, and future intellectual property strategies in the biomarker-related field.Finally, a summary of the recent relevant patents and primary barriers to the translation of new biomarkers into viable clin. diagnostic tests is presented.

A serum ELISA using a monoclonal antibody that detects a MUC5AC‐related antigen (NPC‐1C antigen) expressed by pancreatic and colorectal cancer was developed. The NPC‐1C antibody reacts with specific epitopes expressed by tumor‐associated MUC5AC that does not appear on MUC5AC from normal tissues. Based on observations of a highly specific antibody, we tested the ELISA to differentiate serum from healthy blood donors compared to serum from patients with colorectal or pancreatic cancer. Additionally, patient tumor tissue was stained to examine the expression pattern of MUC5AC‐related antigen in pancreatic and colorectal cancers. The results indicate the NPC‐1C antibody ELISA distinguished serum of cancer patients from normal donors with very good sensitivity and specificity. Most patient′s tumor biopsy exhibited NPC‐1C antibody reactivity, indicating that tumor‐associated MUC5AC antigen from tumor is shed into blood, where it can be detected by the NPC‐1C antibody ELISA. This serum test provides a new tool to aid in the diagnosis of these cancers and immune monitoring of cancer treatment regimens.