NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today it has validated and launched a laboratory developed Fluorescent in Situ Hybridization ("FISH") assay for the surveillance of patients with Barrett's Esophagus ("BE"). The test is highly sensitive for the detection of the presence of esophageal cancer or high grade dysplasia indicative of precancerous changes.
Approximately 3 million Americans suffer from Barrett's Esophagus in the United States, a condition which can be a precursor to esophageal cancer. Although less than 1% of these patients develop cancer each year, esophageal carcinoma is frequently not detected until later stages, at which point therapy options are limited, extremely invasive, and often ineffective. Therefore, early detection is important and regular surveillance is recommended. Endoscopic examinations with multiple tissue biopsies to look for dysplasia and cancer have long been considered the standard surveillance procedure for BE patients. However, current data suggests that an esophageal "brushing" may be more effective than a traditional tissue biopsy, because it allows for the collection of cells from a larger area of the esophagus for testing, which results in less sampling error. Esophageal brushings are also generally easier and less costly to obtain than tissue biopsies.
NeoGenomics' NeoSITE™ Barrett's Esophagus FISH test was designed specifically to be performed on brushing samples and can be used as an objective and easier means to aid in routine surveillance of BE patients. The Company performed an extensive trial to validate this new test in which the test showed initial sensitivity of 86% and specificity of 67% when the Company's proprietary algorithms were used to assist with interpreting the FISH results. Reported sensitivity and specificity levels were even higher when brushing samples were obtained from nodules rather than pan-brushing.
Douglas VanOort , the company's Chairman and CEO, commented, "This FISH test is specifically designed to help pathologists and clinicians monitor BE patients and make more informed treatment decisions. With our commercial launch of this test, we become the first lab in the U.S to offer this important FISH test on a national basis. This extensive development effort is evidence of our commitment to offer highly innovative molecular and genetic tests to support pathologists and clinicians, and to improve patient care."
Dr. Maher Albitar , the Company's Chief Medical Officer and Director of Research and Development, commented, "Improving surveillance in BE patients results in better and potentially earlier treatment for those patients who are likely to progress to esophageal cancer. Our unique approach of performing FISH testing on brushing samples provides a reliable and an objective means of detecting high grade dysplasia and cancer. We believe it will enable a major step forward in BE surveillance programs as it allows clinicians to more easily and frequently tests their BE patients and track quantitative findings over the monitoring period."