Important Advance in the Prevention of Esophageal Cancer Released at the Annual Scientific Meeting of the American College of Gastroenterology

NATIONAL HARBOR, MD--(Marketwire - Oct 31, 2011) - An important advance in the prevention of esophageal adenocarcinoma, the most rapidly growing cancer in the US, is being released for routine clinical use at the Annual Scientific Meeting of the American College of Gastroenterology taking place in National Harbor, M.D., being held from October 28 - November 2. Known as EndoCDx, this new method of testing the esophagus has been shown to dramatically increase the detection of still-harmless but precancerous cells, thus potentially saving many lives from this highly lethal disease.

Esophageal adenocarcinoma, which is caused by the reflux of excess stomach acid into the esophagus, can theoretically be prevented if patients with heartburn receive an upper endoscopy to check for precancerous cells which can then be removed before the cancer is allowed to develop. While over 8 million Americans with heartburn see a gastroenterologist each year for this routine test, many of them with precancerous cells are currently being missed during their endoscopy. This is because the tissue sampling method used during an upper endoscopy relies on using a tiny forceps to test a large area of the esophagus and thus often fails to detect abnormal tissue that may be present.

The newly released EndoCDx test solves this problem by utilizing a specially designed biopsy brush to test a much larger area of the esophagus than can be sampled by a forceps. This large partially disaggregated tissue sample is then subjected to a powerful three-dimensional computer assisted laboratory search for any precancerous cells. While CDx testing adds less than a minute to the standard upper endoscopy procedure it has been shown in large recently published clinical trials to increase the detection of both Barrett's esophagus and esophageal dysplasia, the precancerous precursors of esophageal cancer, by over 40%, making it potentially one of the most recent significant advances in the prevention of any GI cancer.

"Precancer of the esophagus is often invisible during endoscopy and gastroenterologists have long known that about 30% of patients with an abnormality are not being detected because the small biopsy forceps used to sample the esophagus did not happen to land on the abnormal area," said Seth Gross, MD, Director of Advanced Endoscopy at Norwalk Hospital in Connecticut. He continued, "The over 40% increased pickup of disease provided by EndoCDx is a major advance in our goal of making esophageal cancer as preventable as colon cancer. We are therefore now adopting this technique to supplement all routine esophageal biopsies performed at our large regional esophagoscopy center."

Chronic exposure to stomach acids in patients with gastroesophageal reflux disease, or GERD, can damage the lining of the esophagus, leading to a condition called Barrett's esophagus. In patients with Barrett's esophagus, the normal cells lining the esophagus are replaced with tissue that is similar to the lining of the intestine.¹ It is believed that these cells (intestinal metaplasia) form as the body is trying to repair damage to the esophageal lining as a result of prolonged acid exposure.² Patients with intestinal metaplasia are at an increased risk for developing esophageal cancer. Each year, every one in 200 patients diagnosed with Barrett's esophagus develops esophageal cancer. For advanced esophageal cancers, the current treatment options are limited, and odds of survival remain low.³

About Barrett's Esophagus

Barrett's esophagus is a precancerous condition affecting the lining of the esophagus. Barrett's esophagus develops when the protective cells of the esophagus become damaged due to chronic stomach acid exposure. Patients with gastroesophageal reflux disease are at an increased risk for developing Barrett's esophagus. Barrett's esophagus itself does not cause symptoms. The acid reflux that causes Barrett's esophagus often leads to symptoms of heartburn. However, many patients with this condition do not have symptoms.

About Dysplasia
Dysplasia occurs as a series of cell changes as Barrett's esophagus progresses to Barrett's-associated cancer. Dysplasia is considered a precancerous condition and should be monitored very closely to ensure the cells do not become cancerous. Dysplastic cells are very similar to cancer cells but have not yet acquired the ability to invade into tissue or metastasize. Patients with dysplasia are monitored very closely by their physician to ensure there is no further disease progression.

About Esophageal Cancer
Esophageal cancer is the fastest growing cancer in the United States². Esophageal cancer results when abnormal cells metastasize and penetrate the esophageal tissue. Esophageal cancer is usually not curable and once diagnosed just 16% of patients live for five or more years¹. Advanced screening and monitoring of patients with Barrett's esophagus may lead to early detection and improved survival.

About CDx Diagnostics
CDx Diagnostics (www.cdxdiagnostics.com) is the world's leader in the prevention of cancer of the aerodigestive tract including the oral cavity, pharynx, larynx and esophagus, through early detection of their pre-cancerous precursors. Clinicians use CDx patented brush biopsy instruments to non-invasively collect a wide area, disaggregated tissue specimen of the entire thickness of the suspect epithelium. This unique tissue specimen is then subjected to specialized, computer-assisted laboratory analysis. For further information please call (201) 843-5600.

¹ Medical Position Statement on the Management of Barrett's Esophagus," published by the American Gastroenterological Association (AGA) Institute. Gastroenterology, March 2011.

² What is Barrett's Esophagus? Johns Hopkins University. http://pathology2.jhu.edu/beweb/Definition.cfm

³ Medical Position Statement on the Management of Barrett's Esophagus," published by the American Gastroenterological Association (AGA) Institute. The medical position statement was published in Gastroenterology, the official journal of the AGA Institute.