Oral Cancer Prevention International and CDx Laboratories Merge to Form CDx Diagnostics


SUFFERN, NY--(Marketwire - Jan 8, 2013) - Two companies which offer physicians advanced, clinically-proven diagnostic systems that can help prevent cancer by detecting pre-cancerous cells announced their merger today. Oral Cancer Prevention International, Inc. and CDx Laboratories, Inc. are joining to form a new entity known as CDx Diagnostics. The merger was facilitated by a new investment in CDx Diagnostics made by Waterbridge Capital, a New York City-based investment firm, which targets opportunistic equity investments in a number of areas, including promising companies focused on breakthrough diagnostic health technologies.

"Our goal in making this investment is to ensure that the newly merged company has access to the financial and human resources that it requires for rapid growth. It is very unusual for any medical device or diagnostic company to have successfully commercialized even one patented, clinically proven, FDA cleared, and reimbursed product independently, without the resources of a larger company," said Joel Schreiber, CEO of Waterbridge Capital.

"We are pleased to be able to consolidate our oral, esophageal, and laryngeal cancer diagnostic assets into one company that can better leverage our investment in the proprietary computer algorithms and systems that we have developed to improve the detection of pre-cancerous cells. We welcome Waterbridge Capital as a board member and look forward to a mutually beneficial relationship," said Mark Rutenberg, Chairman and CEO of CDx Diagnostics.

He continued, "This merger streamlines our capital structure and allows us to accelerate our strong pipeline of additional tests for liver, pancreatic, and Inflammatory Bowel Disease caused colon cancer. CDx Diagnostics will now fortify its leadership in developing advanced tools that deliver unparalleled information to doctors so they can rule out or confirm precancer while it is still easily treatable."

CDx Diagnostics' business model is based upon the recognition that detecting easily treatable pre-cancerous cells known as "dysplasia" can be the most effective method to prevent cancer. The Pap smear, which reduced cervical cancer from the most frequent cause of U.S. female cancer death in the 1950s to the 14th largest by 1990, is an example of how availability of the right tool to detect dysplasia can stop cancer before it can actually start. While pre-cancerous cell detection has made cervical, skin and most colon cancer now largely preventable diseases, the detection of dysplasia in other body sites has been more elusive. CDx Laboratories was founded in 1997 to develop tools to detect dysplasia in tissues for which no practical and accurate tests were available. Its proprietary diagnostic platform consists of a patented minimally invasive brush biopsy method combined with a powerful computer-assisted laboratory analysis of the cells and tissue fragments obtained by the biopsy brush. Its tests are relatively quick and are covered by insurance.

In 2007, Oral  Cancer Prevention International was founded to utilize the CDx technology platform to detect pre-cancerous cells in the mouth. Its OralCDx test is currently utilized by thousands of U.S. physicians and dentists to rule out the chance that a small common-appearing oral spot may contain pre-cancerous cells. For the last 20 years oral  cancer has been rapidly rising in women, young people and non-smokers. Oral CDx has already prevented over 10,000 U.S. oral  cancers by detecting advanced precancerous cells in hundreds of thousands of patients with harmless appearing small oral spots.

Esophageal adenocarcinoma, the result of chronic heartburn, is the most rapidly growing U.S. cancer, quadrupling in white American men over 40 in the last 20 years. In 2011, two large clinical studies were published demonstrating that by using the EndoCDx WATS3D biopsy (Wide Area Transepithelial Sample with 3 Dimensional Analysis), provided by CDx Laboratories, during the routine upper endoscopy performed on millions of Americans with heartburn each year, gastroenterologists can quickly and easily increase their detection of its treatable pre-cancerous precursors -- Barrett's esophagus and esophageal dysplasia -- by up to 40%. These studies show that WATS3D can detect cases of esophageal precancer that were missed by the standard random biopsy technique performed during upper endoscopy.

These results have been replicated in other studies of the WATS3D biopsy released during 2012. While expanded clinical trials continue since the WATS3D method became commercially available in early 2012, it has already become a part of routine clinical practice in many of the largest academic and community gastroenterology centers in the United States.

"Based on almost six months of diligence, we have confirmed a remarkable level of enthusiasm among physicians for CDx's computer-assisted biopsy approach for detecting still-harmless, but pre-cancerous cells. We believe that even fractional penetration for its two currently available tests in the U.S. market alone can prevent thousands of oral and esophageal cancers," added Joel Schreiber.

About CDx Diagnostics and WATS3D biopsy
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 easily treatable, pre-cancerous precursors. Clinicians use CDx patented WATS3D 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. In clinical trials, CDx Diagnostics' WATS3D biopsy 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. The high sensitivity of WATS3D is due to the large tissue area sampled, and the proprietary 3-Dimensionial computer imaging system that is based on an algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program.

About Barrett's Esophagus and Esophageal Cancer
Many cases of esophageal adenocarcinoma (EA) are preceded by chronic heartburn. Some heartburn patients develop altered cell patches in their esophagus. A condition known as dysplasia occurs 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. Esophageal cancer is now the fastest growing form of cancer in the United States.3

About Oral Precancer and Oral Cancer
Oral cancer kills about as many Americans as melanoma, twice as many as cervical cancer, and is now rapidly increasing in the formerly low risk groups of women, young people, and non-smokers. Oral cancer can be prevented if it is detected in its precancerous (dysplastic) stage. Oral precancer typically appears as a visible, small, innocuous appearing white or red tissue spot. While the vast majority of these routine oral spots are harmless, the only two ways to rule out the presence of precancerous cells are a scalpel biopsy, or a painless, computer-assisted, transepithelial brush biopsy (OralCDx) of the oral spot.

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 Endo CDx 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

3 http://emedicine.medscape.com/article/277930-overview#a0199


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