CDx Diagnostics said results from a recent multicenter prospective trial show the use of its WATS3D test increases the detection of both Barrett’s esophagus and esophageal dysplasia by more than 80%. The results were published in the latest issue of United European Gastroenterology Journal and featured in the American Society for Gastrointestinal Endoscopy (ASGE’s) Scope Tech Talk Video Series.

The trial was conducted at 25 community-based gastrointestinal (GI) centers across the U.S. In the study, 4,203 patients were tested for esophageal disease. The findings show that with the inclusion of WATS3Doverall detection of Barrett’s increased by 83%, while the detection of dysplasia increased by 88%. The study concludes that the sampling error can be improved dramatically with use of WATS3D.

“There are a lot of technologies that only work in academic centers,” Mark Rutenberg, founder and CEO of CDx Diagnostics, told MD+DI. “A lot of things work in academia … but don’t work in a critical practice. WATS3D has been now shown to work extremely well in the academic settings and in the community practices. What this study shows is WATS3D works in the real world.”

The test received regulatory clearance in 2012 and was launched in 2014, Rutenberg said. 

WATS3D works by collecting a more varied sample of tissue than individual pokes using forceps and collects more samples to analyze than cytology. These are then analyzed in 3D throughout the entire sample to spot any signs of disease. With WATS3D, the physician uses a stiff-bristled brush to scrape around the esophageal wall in an up-and-down motion. The brush allows for more and deeper sampling than forceps.  CDx Diagnostics’s test employs missile defense technology from President Ronald Reagan’s U.S. Strategic Defense Initiative, better known as the Star Wars program.

There is a strong market and need for WATS3D since Esophageal adenocarcinoma, is one of the most fatal and fastest growing cancers in the U.S.  Esophageal adenocarcinoma can be prevented if detected at a precancerous stage. Rutenberg said that gastroenterologists often perform endoscopies to detect the disease, but this can be ineffective. A major problem with this strategy endoscopists had to rely on taking small random forceps biopsies at 1-2 cm intervals to find these abnormal cells, leaving more than 96% of the endoscopically suspect area completely untested.