Novel FISH probes for the prognosis of malignant transformation in Barrett’s epithelium

Left: Translocations as visualized by FISH assay during metaphase.  Right: Fusion as visualized in human esophageal adenocarcinoma tissue section


Invention Summary:

Barrett’s epithelium (BE) is a premalignant tissue that can progress into esophageal adenocarcinoma (EA) following the metaplasia→low grade dysplasia→ high grade dysplasia→cancer sequence. Although patients with BE have a 120-fold higher risk of developing EA, only 30% of the patients with high grade dysplasia actually develop cancer. The current standard of care is to identify the BE tissue during endoscopy, obtain biopsies and determine the stage of disease by histopathology i.e., appearance of cells. These methods often remain indeterminate in defining type of dysplasia and hence the risk for cancer development. Hence all patients with dysplasia undergo surgery for removal of the diseased tissue to prevent cancer, that may not develop in majority of the patients. This increases the cost of medical care, post-surgical complications and severely compromises the quality of life of the BE patients who are not at risk for EA.

Our team of scientists has discovered chromosomal abnormalities that appear before the BE cells become malignant in a human disease model. In pilot studies, using customized DNA probes, and fluorescence in-situ hybridization (FISH) assay, these abnormal chromosomal events were detected in human EA and not in the benign BE biopsy tissues.


Market Applications:

First of its kind genetic test to provide an objective cancer screening tool in patients with diagnosis of BE metaplasia, low grade and indeterminate type dysplasia.

Advantages:

  • Early prediction of malignancy
  • Objective confirmatory test
  • Can be combined with traditional pathology procedures

Next R&D Steps:

  • Further clinical validation on human tissue samples
  • Development of a kit and pathology workflow

Intellectual Property & Development Status:

Issued Patent US 11,22,711 B2. Available for licensing and/or research collaboration. For any business development and other collaborative partnerships, contact:  marketingbd@research.rutgers.edu

Patent Information: