CDx Diagnostics

About CDx Diagnostics

CDx Diagnostics, founded in 1997 by Mark Rutenberg, is a specialized anatomic pathology laboratory focused on the early detection of precancerous cells to prevent cancers of the esophagus, oral cavity, and pharynx. Rutenberg, an Ernst & Young Entrepreneur of the Year award recipient in Life Sciences, has a background in applying advanced digital image processing from missile defense programs to medical diagnostics. The company emerged from the 2013 merger of CDx Laboratories and Oral Cancer Prevention International, a move facilitated by an investment from Waterbridge Capital. In 2017, the company underwent a majority recapitalization by Galen Partners, a healthcare-focused growth equity firm.

The company's core business revolves around its proprietary WATS3D (Wide Area Transepithelial Sampling with 3D Tissue Analysis) diagnostic platform. This platform serves clinicians by offering a cost-effective and widely reimbursed tool for identifying precancerous cellular changes. The business model is based on providing these advanced diagnostic tests, which are covered by Medicare and most major insurance plans, directly to gastroenterologists and other physicians. The process involves a physician using a patented brush biopsy instrument to collect a wide-area tissue sample, which is then sent to a CDx laboratory for computer-assisted analysis.

The WATS3D system is a 'first-of-a-kind' AI-powered digital pathology system that recently received FDA Breakthrough Device Designation. Its key feature is the combination of a specialized brush for collecting a wide-area, full-thickness tissue sample with a sophisticated 3D computer imaging system. This system employs an AI neural network, originally developed from U.S. Strategic Defense Initiative technology, to analyze over 100 optical slices of the tissue, creating a composite 3D image. This method allows for a more comprehensive analysis than standard random forceps biopsies, significantly increasing the detection rate of Barrett’s esophagus and dysplasia. Clinical trials have shown that adjunctive use of WATS3D can increase the detection of these conditions by over 150%. The company is also developing applications of its platform for cancers of the bile duct, stomach, and colon.