Dental industry news: Companies merge to form CDx Diagnostics

Oral Cancer Prevention International, Inc., and CDx Laboratories, Inc., are joining to form a new entity known as CDx Diagnostics.

Jan 8th, 2013

Two companies offering advanced, clinically-proven diagnostic systems that can help prevent cancer by detecting pre-cancerous cells have announced their merger. 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.

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“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, chief executive officer 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 chief executive officer of CDx Diagnostics. “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 1950’s 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. OralCDx 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,” Schreiber added.

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