SOURCE: CDx Diagnostics

February 01, 2012 10:15 ET

GI Pathology Signs Exclusive Marketing Agreement for CDx Diagnostics' Computer-Aided Brush Biopsy Test

Studies Show EndoCDx® EGD Enhances Detection of Barrett's Esophagus and Dysplasia by up to 40%

MEMPHIS, TN and SUFFERN, NY--(Marketwire - Feb 1, 2012) - GI Pathology, a dominant player in the gastrointestinal pathology market, and CDx Diagnostics, the leader in deploying computer-aided analysis to detect and prevent cancers of the esophagus, oral cavity, pharynx, and larynx, announced today an exclusive agreement for GI Pathology, a division of Poplar Healthcare, to market EndoCDx® EGD starting February 1, 2012.

In clinical trials, CDx Diagnostics' EndoCDx EGD, a patented computer-aided brush biopsy examination, significantly increased the detection rate of Barrett's esophagus in GERD patients as well as precancerous changes in esophageal tissue (dysplasia) by up to 40%1,2.

"We are excited about our new partnership with CDx Diagnostics which underscores our commitment to providing our customers with quality products and services that improve patient care," said William E. McDowell, CEO of Poplar Healthcare. "EndoCDx EGD represents an important breakthrough in detecting Barrett's esophagus and dysplasia. As the largest and fastest-growing physician-owned GI specialty laboratory in the country, we look forward to providing the gastroenterology community with access to this new cutting-edge advance."

The National Institutes of Health (NIH) suggests screening and biopsy in people diagnosed with Barrett's esophagus may lead to early detection and improved survival. Gastroenterologists use the EndoCDx brush biopsy in conjunction with standard biopsy techniques to collect, through this minimally invasive procedure, a full thickness tissue specimen over a larger surface area. This unique tissue specimen is analyzed by both a state-of-the-art quantitative image analysis system as well as by a certified pathologist for early signs of cancer.

Many cases of esophageal adenocarcinoma (EA) are preceded by chronic heartburn. About 30 million Americans report having heartburn at least twice a week. This condition, also known as Gastro-Esophageal Reflux Disease or GERD, is not only uncomfortable, but potentially dangerous.

"The failure to detect Barrett's esophagus with or without high grade dysplasia due to sampling error is a major concern for endoscopists," said Paul A. Akerman, M.D., Clinical Assistant Professor of Medicine at Brown University. "CDx technology is a major leap forward in detection and gives the endoscopist greater confidence in the pathologic diagnosis. The GI community is excited about this advancement in detection of pre and early cancers of the esophagus."

Mark Rutenberg, Chairman and CEO of CDx Diagnostics, stated, "We are delighted to enter into this agreement with GI Pathology due to their leading position in the GI market as well as their record of providing the highest level of quality care to their physician customers and their patients. We are confident that they will prove to be an excellent partner to help us launch the EndoCDx EGD test in the US market."

About EndoCDx® EGD
The EndoCDx EGD test is an adjunct to standard endoscopic evaluation with multiple random forceps biopsies. The EndoCDx technology employs a patented instrument to obtain a wide area sample of the entire thickness of the esophageal mucosa in a targeted area of the esophagus. This unique tissue sample is then analyzed at the laboratory with the aid of quantitative image analysis to help identify precancerous abnormality in time for effective treatment. The addition of EndoCDx to standard forceps biopsy has been shown to increase the detection of both Barrett's esophagus and esophageal dysplasia, the treatable precursors of esophageal adenocarcinoma, by up to 40%.

About Barrett's Esophagus
About 10% of patients with GERD, or 3 million Americans, will develop small areas of altered cells in their esophagus. This condition, known as Barrett's esophagus, is not harmful in itself. However, each year about 0.5% of people with Barrett's will develop esophageal cancer from the Barrett's area of their esophagus. The number of Americans diagnosed with esophageal adenocarcinoma has increased 600% over the last 25 years. It is now the fastest growing form of cancer in the U.S., and its incidence is rising faster than breast cancer, prostate cancer, or melanoma. Esophageal adenocarcinoma is also one of the most lethal of cancers, with a five year survival rate of less than 20%.

About GI Pathology
GI Pathology is a division of Poplar Healthcare, a leading laboratory services company founded in 1995 and headquartered in Memphis. Through its GI Pathology, D-PATH Dermatopathology and OncoMetrix Oncology brands, Poplar Healthcare provides specialized laboratory testing services to a nationwide client base of gastroenterologists, dermatologists, oncologists and their patients. For more information on Poplar Healthcare, call 901.526.1912 or visit www.poplarhealthcare.com.

About CDx Diagnostics
CDx Diagnostics (www.cdxdiagnostics.com) is the world's leader in the prevention of cancer of the oral cavity, pharynx, larynx and esophagus through early detection of their pre-cancerous precursors. Clinicians use CDx patented brush biopsy instruments to collect, through minimally invasive procedures, 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.

1 Johanson, J. F., J. Frakes, D. Eisen, (2010). Computer-assisted analysis of abrasive transepithelial brush biopsies increases the effectiveness of esophageal screening: a multicenter prospective clinical trial by the endocdx collaborative group. Dig Dis Sci, e-pub

2 Anandasabapathy, Sharmila, Stephen Sontag, David Y. Graham, Stephen Frist, Joan Bratton, Noam Harpaz, Jerome D. Waye. (2010). Computer-assisted brush-biopsy analysis for the detection of dysplasia in a high-risk barrett's esophagus surveillance population. Dig Dis Sci, e-pub

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