CDx Diagnostics | Top Endoscopy Solution Company 2018

MedTech Outlook Magazine

CDx Diagnostics
Cancer Prevention through Enhanced Precancerous Cell Detection and Removal

CIO VendorMark Rutenberg, Founder & CEO
According to one study, one of every three people in the U.S. will develop some form of malignancy during their lifetime. One such aggressive form of cancer—Esophageal Cancer—can be prevented before developing, believes Mark Rutenberg, Founder and CEO of CDx Diagnostics. “We embarked on a mission to pre-empt the occurrence of cancer in a world that considers that its early detection is the best possible outcome of modern medicine,” says Rutenberg. With its blue-sky thinking, CDx Diagnostics has enhanced the detection of precancerous cells to prevent Esophageal Adenocarcinoma, which is also one of the most rapidly growing cancers in the U.S. This disease involving the distal esophagus is usually diagnosed at an advanced stage and is relatively unresponsive to radiation therapy or chemotherapy. Physicians are using the WATS3D tissue sampling kit to help them detect pre-cancerous cells so they can then apply endoscopic therapy to destroy the cells before they can progress to adenocarcinoma.

Physiciansuse several diagnostic and therapeutic tools to manage esophageal diseases, like narrow band imaging, tissue sampling, and ablation. However, WATS3D has been a game changer in this area. It empowers gastroenterologists, GI surgeons,and pathologists to find precancerous cells missed by standard sampling techniques before it’s too late. It starts with an esophageal tissue sample taken by a gastroenterologist or GI surgeon with an histocytology brush that allows physicians to get a Wide- Area Transepithelial Sample (WATS). Because this unique tissue sample is up to 150 microns thick and a standard microscope can only evaluate a 3 micron think specimen the tissue sample is sent to CDx’s lab for processing, using an advanced computer image analysis system that incorporates a neural network with molecular biology and 3D cytopathology.

A proprietary imaging and computer network that creates a three-dimensional view is used to scan several thousand cell images.

We embarked on a mission to pre-empt the occurrence of cancer


CDx’s proprietary neural network uses artificial intelligence to aid in the complex process of scanning and sortingover a hundred thousand computer images to identify the 100 images most likely to have unhealthy or precancerous cells. The 3D images produced by the network play a unique and vital role in helping pathologists to make a definitive diagnosis. This process appeals to CIOs who are looking to leverage technology for real-world outcomes.Suspicious cells are rescanned at higher resolution, and the most suspicious of these are flagged as a starting point for the expert pathologist’s analysis. The pathologist renders the tissue diagnosis after reviewing the images flagged by the computer.

“Our neural network builds on software developed in the Department of Defense to distinguish between missiles and drones—and now we apply this technology to finding cells that could potentially threaten the patient’s life,” explains Rutenberg. The high sensitivity of WATS3D is largely due to its neural network and clinical analysis that performs sophisticated tests on every cell on the slide to catch any sign of potential abnormality early and has only become more accurate with constant use over the last ten years.

“We have generated a growing body of peer-reviewed clinical evidence that shows the potential WATS3D exhibits in aiding physicians in the process of finding more precancerous cells in the esophagus than with random forceps biopsy,” states Rutenberg. Most recently, physicians who used WATS3D shared data that showed WATS3D tissue samples progress to adenocarcinoma at a rate similar to or faster than forceps biopsy.

CDx’s clinical success has led to the rapid expansion of all functions within the company and partnerships with external pathologists trained by CDx in reading the company’s 3D computer images. A clinical study has begun in Europe, which aims to expand the use of the WATS3D test to other countries in near future. “We are also carrying out studies to determine the possibility of applying our technology to other parts of the body,” concludes Rutenberg.

Top 10 Endoscopy Solution Companies - 2018

Company
CDx Diagnostics

Management
Mark Rutenberg, Founder & CEO

Description
Aids in the detection and prevention of cancers of the esophagus, oral cavity, pharynx, and larynx

CDx Diagnostics News

From Paper To Digital Study Management In Large Patient Registries For CDx Diagnostics

CDx Diagnostics, a medical device diagnostics company, sought an electronic data capture (EDC) platform for their registry studies. Specifically, they required a system that could be managed internally and offered user-friendly features, payment tracking capabilities, and robust customer support. After careful consideration, CDx Diagnostics selected TrialKit as their EDC platform, which not only met but exceeded their expectations.
One of the standout features of TrialKit was its mobile app, which allowed the research coordinator to conveniently access and manage data on the go. Additionally, TrialKit offered role-based permissions, enabling the coordinator to build their own forms and make necessary changes effortlessly. This flexibility greatly improved the efficiency and accuracy of data collection.
Get all the details by accessing the case study below to see why CDx Diagnostics found TrialKit to be the ideal EDC platform for their registry studies.

WATS3D® Significantly Boosts Barrett's Esophagus and Dysplasia Detection Rates in Landmark Clinical Study

Pivotal Multi-Center Study Highlights AI Platform's Powerful Diagnostic Impact and Ability to Enhance Patient Outcomes
SUFFERN, N.Y., -- CDx Diagnostics, Inc., developer of the WATS3D AI Platform for the detection and surveillance of Barrett's esophagus (BE) and dysplasia, today announced the publication of a new study, Adjunctive Use of WATS-3D In Symptomatic GERD Patients Increases Detection of Barrett's Esophagus and Dysplasia, in The American Journal of Gastroenterology. The pivotal study highlighted WATS3D's significant impact on improving precancer detection during GERD screenings. Adding WATS3D to these screenings resulted in the identification of 20% more Barrett's cases and doubled dysplasia diagnoses vs. biopsy alone. The WATS3D diagnosis influenced the clinical management of over 90% of patients based on findings missed by forceps. Strikingly, 1 in 5 patients would have been unaware of their precancerous Barrett's esophagus condition without WATS3D.
The study, led by Nicholas J Shaheen, MD et al., evaluated 23,933 patients, where WATS3D identified intestinal metaplasia in 19.3% and, of 240 patients with dysplasia, 107 (45%) that were missed by forceps biopsy. WATS3D demonstrated 77% adjunctive and 18% absolute yield in the detection of IM in patients with endoscopic BE criteria. This resulted in care plans changing in 91% of WATS3D positive but biopsy negative cases.
"Compared to forceps biopsy alone, WATS3D identified around 20% more Barrett's cases that would've been missed. We also observed nearly double the dysplasia diagnoses," said lead author, Dr. Shaheen, Chief, Division of Gastroenterology & Hepatology, University of North Carolina School of Medicine at Chapel Hill.
"This represents our largest clinical study of WATS3D to date and one of the most impactful," said Duane Dorn, CDx COO. "The landmark findings highlight how our AI imaging technology can effectively transform early detection rates and empower physicians to intervene before progression to esophageal cancer. Improving patient lives through earlier detection is the driving force behind our innovations."
Patients with GERD frequently show columnar-lined epithelium, but forceps biopsies often fail to confirm intestinal metaplasia. WATS3D leverages AI and 3D imaging to reliably identify precancerous cells, providing actionable insights to guide BE management.
Visit us at the Digestive Disease Week (DDW) 2024 Annual Meeting, being held May 18-21, in Washington DC, Booth #3807, or online at WATS3D.com to learn more.