A single-tube detection assay to screen for early stages of pancreatic cancer via two newly identified DNA methylation biomarkers in the form of a blood test.
DNA promoter methylation is a signature for silencing of tumor suppressor genes in most cancers. Two new genes with specific DNA promoter methylation alterations have been identified as promising biomarkers in early detection of pancreatic cancer. Most widely used methods to detect DNA methylation involve three separate and independent processes: DNA extraction, bisulfite conversion, and methylation detection via PCR method. This method is very time consuming and often involves losses of material, potentially reducing the analytical sensitivity required for analysis of challenging clinical samples. This invention is a new nanoparticle-based technology that combines three processes into a single-tube for quick and simple detection of the DNA methylation biomarkers directly from blood samples for early pancreatic cancer detection. Additional advantages include:
• ~80% accurate for early diagnosis w/out false positives in normal patient samples
• Assay can use patient sputum, serum and blood as specimen
• High sensitivity and specificity
• Suitable for small sample
• Minimal loss of patient sample
• Quick and automated
• Early detection of cancer can improve mortality and morbidity
Johns Hopkins researchers have identified two novel biomarkers and additionally a companion nanotechnology based method for early pancreatic cancer detection. A genome-wide pharmacologic transcriptome approach was used to identify DNA methylated promoters of BNC1 and ADAMTS1 genes as novel biomarkers in pancreatic cancer cell lines. The biomarkers were then detected using a single-tube diagnostic assay based on Methylation-On-Beads (MOB) technology directly from blood samples. MOB is a rapid and highly efficient method for DNA extraction, bisulfite treatment and detection of DNA methylation using silica superparamagnetic particles (SSP). SSP first captures genomic DNA from raw tissue samples and then sodium bisulfite treatment is carried out in the presence of SSP without tube transfers. Finally, the bisulfite treated DNA is analyzed to determine the methylation status. All steps are implemented without centrifugation or air drying in a single tube that provides superior yields relative to conventional methods for DNA extraction and bisulfite conversion. This detection method showed an overall sensitivity of 83.7% and a specificity of 84.6%.
Looking for Partners
To develop and commercialize the technology as an early cancer diagnostic kit, DNA methylation detection kit and DNA extraction and analysis system.
Stage of Development
Under CDA /NDA
Nita Ahuja, Vasudev Bailey, Stephen B. Baylin, James G. Herman, Jeff Tza-Huei Wang, JooMi Yi
U.S. Published Patent Application No. 2013-0288241 A1
Clin Chim Acta. 2013 Oct 21;425:169-75;
Clin Cancer Res. 2013 Dec 1;19(23):6544-55
Associated Case: C10249
Biomarker, Nanotecnology, Cancer, Early-stage cancer, Detection Assay, DNA extraction, DNA methylation