- Newly issued coverage statement on diagnostic platform for screening and surveillance of Barrett’s esophagus -
SUFFERN, N.Y., April 02, 2020 (GLOBE NEWSWIRE) -- Effective Jan. 21, 2020 – CDx Diagnostics, Inc. is pleased to announce that we are now contracted with Blue Cross Blue Shield (BCBS) of Massachusetts for all products. CDx Diagnostics, Inc. is excited to service BCBS of Massachusetts patients as an in-network provider.
Barrett’s Esophagus (BE), often diagnosed in people with gastroesophageal reflux disease (GERD), is a condition where the lining of the esophagus connecting the mouth and stomach, changes to tissue similar to the smaller intestine. BE affects about two million people and is associated with an increased risk of developing esophageal cancer (EC), one of the leading causes of cancer deaths worldwide.
The effectiveness of upper endoscopy is widely recognized to be limited by the high rate of false-negative sampling error associated with standard 4-quadrant random biopsy, due to esophageal dysplasia (ED) being both highly focal and typically invisible. WATS3D, or Wide Area Transepithelial Sampling with 3D Tissue Analysis, when used adjunctively with standard 4-quadrant random biopsies, addresses this limitation by using an abrasive sampling brush to create a wide area tissue sample that, unlike standard cytology instruments, also captures the full thickness of the epithelium by penetrating the submucosa. The combined medical advances of superior sampling and advanced 3D imaging means WATS3D has far-reaching implications for protecting patient health.
“CDx Diagnostics, Inc. is proud to service BCBS of Massachusetts patients, with nearly 3 million members statewide, as an in-network provider,” said Bill Huffnagle, CEO of CDx Diagnostics. “WATS3D will now help cover many more patients with known or suspected BE and hopefully aid patients in receiving necessary and timely treatment to prevent esophageal cancer.”
This announcement follows the 2019 American Society for Gastrointestinal Endoscopy (ASGE) update, which included WATS3D in its Standards of Practice Committee’s guideline for the screening and surveillance of BE. A copy of the Standards of Practice Committee’s guideline can be found here.
About Esophageal Cancer & WATS3D
Esophageal adenocarcinoma (EAC) is one of the fastest growing and most fatal cancers in the United States, with an incidence that has quadrupled in men over the past two decades. According to the American Cancer Society, an estimated 18,440 new cases of EAC will be diagnosed this year, resulting in approximately 16,170 deaths. EAC can be prevented if it is detected and treated while still a harmless precancerous change which is the motivation for the millions of upper endoscopies performed each year on patients with GERD and Barrett’s Esophagus (BE).
A key factor limiting the effectiveness of this strategy is the fact that esophageal cancer is both highly focal and invisible and random biopsy sampling tests less than 5% of the known or suspected BE segment. The impact of these limitations is significant, as a previously reported study showed that 25% of cancer patients diagnosed with EAC had undergone an upper endoscopy with Forceps biopsy (FB) in the previous two years.
In contrast, WATS3D addresses the major inadequacies inherent in current random forceps biopsy testing of the esophagus by sampling a much greater tissue area which enables detection of dysplastic and abnormal cells that are located between FB samples. The wider sampling area with WATS3D sharply increases the routine detection of BE and esophageal dysplasia compared with FB alone.
Critically, the computer-synthesized WATS3D image presents an in vivo, en face view of the gland to the pathologist — allowing for a definitive diagnosis of dysplasia in cases that would otherwise be reported as “indefinite.”
Additionally, the WATS3D computer-assisted technology yields sharply higher inter-observer agreement among pathologists compared with FB due to the WATS3D neural network which highlights the most suspicious areas on these computer-synthesized image areas for consistent pathologist review.
About CDx Diagnostics
CDx Diagnostics’ mission of Empowering Physicians With Innovative Technology To Prevent Esophageal Cancer, One Patient At A Time is accomplished by a proprietary diagnostic platform that synthesizes computer imaging, artificial intelligence, molecular biology and three-dimensional cytopathology to detect precancerous change earlier and more reliably than prior methods. CDx tests require only a few minutes of practice time, are cost-effective, and address a recognized critical gap in the current diagnostic standard of care that results in thousands of otherwise unnecessary cancer deaths each year. Routine clinical use of CDx testing has already detected thousands of precancers that would otherwise have been missed in time for effective endoscopic treatment. Additionally, CDx Diagnostics is looking to apply its next-generation diagnostic platform to prevent cancers of the bile duct, stomach, and IBD affected colon. CDx Diagnostics is a Galen Partners portfolio company.