Abstract: The methods provided herein relate to the identification of novel DNA biomarkers and the use of the aberrant methylation patterns of the DNA biomarkers to diagnose small cell lung cancer (SCLC). Such methods may include diagnosing SCLC when there is an increase in methylation of one or more DNA biomarkers in a test sample compared with that in a normal sample. DNA methylation patterns of DNA biomarkers on a genome-wide scale may be determined using a variety of methods including the methylated-CpG island recovery assay (MIRA). In some embodiments, methods of treating a subject for SCLC or monitoring the treatment are also provided. Methods may include measuring the methylation levels of one or a combination of DNA biomarkers and administering chemotherapy to a subject when there is an increase in the methylation levels of the test sample in relation to that of the normal sample or standard sample.

Abstract: The present invention relates to the identification of novel DNA biomarkers and the use of the aberrant methylation patterns of the biomarkers to diagnose a disease or a condition (e.g., a cancer) associated therewith. In particular, the present invention relates to the use of the novel DNA biomarkers to diagnose lung cancers, e.g., squamous cell carcinomas and adenocarcinomas.

Abstract: One aspect of the present disclosure relates to a composition comprising a DNA hypermethylation brain cancer marker on acellular DNA of a human subject. DNA hypermethylation brain cancer markers (or DNA hypermethylation markers) are frequently methylated in the DNA of brain cells and acellular DNA of individuals suffering from brain cancer. These DNA hypermethylation markers are not frequently methylated in the DNA of brain cells and acellular DNA of individuals who do not suffer from brain cancer. Another aspect of the present disclosure relates to a method of diagnosing brain cancer in a human subject comprising providing a sample containing acellular DNA from the human subject, determining whether one or more DNA hypermethylation markers on the acellular DNA are hypermethylated, and diagnosing brain cancer when the DNA hypermethylation markers are hypermethylated.

Abstract: The present invention relates to the identification of novel DNA biomarkers and the use of the aberrant methylation patterns of the biomarkers to diagnose a disease or a condition (e.g., a cancer) associated therewith. In particular, the present invention relates to the use of the novel DNA biomarkers to diagnose lung cancers, e.g., squamous cell carcinomas and adenocarcinomas.

Abstract: The present invention provides new and improved assay for detection of genomic methylated CpG islands. This new method is termed the methylated-CpG island recovery assay (MIRA). In accordance with one embodiment, MIRA comprises the steps of: (a) incubating genomic DNA fragments with a methylated CpG island binding protein in the presence of a binding partner for the binding protein to produce bound DNA containing methylated CpG islands, (b) isolating the bound DNA, and (c) detecting CpG island methylation by gene-specific amplification reactions. In accordance with a preferred embodiment, MIRA comprises the steps of: (a) incubating sonicated genomic DNA with a matrix containing a fusion protein of glutathione S-transferase (GST) and MBD2b (GST-MBD2b) in the presence of MBD3L1 to produce bound DNA containing methylated CpG islands, (b) eluting bound DNA from the matrix, and (c) detecting CpG island methylation by gene-specific amplification reactions.

Abstract: The present invention relates generally to the field of human genetics. Specifically, the present invention relates to methods and materials used to isolate and detect a human tumor suppressor gene, termed RASSF1 herein. More specifically, the invention relates to the analysis of the RASSF1 gene and its use in the diagnosis of predisposition to cancer. The invention also relates to the prophylaxis and/or therapy of cancer associated with the RASSF1 gene. The invention further relates to the screening of drugs for cancer therapy. Finally, the invention relates to the screening of the RASSF1 gene for methylation, loss of heterozygosity or mutations, which are useful for diagnosing the predisposition to cancer.

Abstract: The present invention relates generally to the field of human genetics. Specifically, the present invention relates to methods and materials used to isolate and detect a human tumor suppressor gene, termed RASSF1 herein. More specifically, the invention relates to the analysis of the RASSF1 gene and its use in the diagnosis of predisposition to cancer. The invention also relates to the prophylaxis and/or therapy of cancer associated with the RASSF1 gene. The invention further relates to the screening of drugs for cancer therapy. Finally, the invention relates to the screening of the RASSF1 gene for methylation, loss of heterozygosity or mutations, which are useful for diagnosing the predisposition to cancer.