BREAKTHROUGHDATA

Demonstrated Efficacy in both screening and surveillance populations:

  • Adjunctive use of WATS3D has increased the diagnostic yield for Barrett’s Esophagus, LGD, HGD and EAC
  • Barrett’s esophagus – WATS3D increased detection by up to 150.6%
  • Dysplasia – WATS3D increased detection by up to 242%
  • High-grade Dysplasia/Adenocarcinoma – WATS3D is 4x as effective as the standard Seattle Protocol at detecting HGD
  • CDx Inter-observer agreement is up to 3x higher than the industry average

Published Studies 2018

Increased detection of Barrett’s esophagus and esophageal dysplasia with adjunctive use of wide-area transepithelial sample with three-dimensional computer-assisted analysis (WATS)

Seth A Gross, MD, Michael S Smith, MD and Vivek Kaul, MD; the US Collaborative WATS3D Study Group

Key Findings: Of 4203 patients, 594 were diagnosed with BE by FB alone, and 493 additional cases were detected by adding WATS,increasing the overall detection of BE by 83% (493/594, 95% CI 74%–93%). Low-grade dysplasia (LGD) was diagnosed in 26 patients by FB alone, and 23 additional cases were detected by adding WATS, increasing the detection of LGD by 88.5% (23/26, 95% CI 48%–160%).

Conclusion: Adjunctive use of WATS to FB significantly improves the detection of both BE (83%) and ED (88.5%). Sampling error, an inherent limitation associated with screening and surveillance, can be improved with WATS allowing better informed decisions to be made about the management and subsequent treatment of these patients.

Published Studies 2017

Increased Detection of Barrett’s Esophagus-associated Neoplasia Using Wide-Area Trans-epithelial Sampling: A Multicenter, Prospective, Randomized Trial

Prashanth R. Vennalaganti, M.D., Vivek Kaul, M.D., Kenneth K. Wang, M.D., Gary W. Falk, M.D., MS, Nicholas J. Shaheen, M.D., Anthony Infantolino, M.D., David A. Johnson, M.D., Glenn Eisen, M.D., MPH, Lauren B. Gerson, M.D., Michael S. Smith, M.D., Prasad G. Iyer, M.D., MS., MPH, Charles J. Lightdale, M.D., Felice Schnoll-Sussman, M.D., Neil Gupta, M.D., MPH., Seth A. Gross, M.D., Julian Abrams, M.D., MPH, Gregory B. Haber, M.D., Ram Chuttani, M.D., Douglas K. Pleskow, M.D., Shivangi Kothari, M.D., John R. Goldblum, M.D., Yaxia Zhang, M.D., Prateek Sharma, M.D. DOI: http://dx.doi.org/10.1016/j.gie.2017.07.039

Key Findings: One hundred sixty patients (mean age 63.4 years, 76% male; 95% white) completed the trial. The median circumferential and maximal BE extents were 1.0 (IQR: 0.0-5.0) cm and 4.0 (IQR, 2.0-8.0) cm, respectively. The diagnostic yield for biopsy alone was as follows: HGD/EAC, 7 (4.4%); low-grade dysplasia (LGD), 28 (17.5%); non-dysplastic BE (NDBE), 106 (66.25%); and no BE, 19 (11.9%). The addition of WATS to biopsy yielded an additional 23 cases of HGD/EAC (absolute increase, 14.4%; 95% CI, 7.5%-21.2%). Among these 23 patients, 11 were classified by biopsy as NDBE, and 12 as LGD/IND; 14 received biopsy and 9 WATS first (p=NS) and the majority (n=21; 91.7%) had a prior dysplasia history. WATS added average of 4.5 minutes to the procedure.

Conclusion: Results of this multicenter, prospective, randomized trial demonstrate that the use of WATS in a referral BE population increases the detection of HGD/EAC.

Clinical Studies 2016

Increased Detection of Barrett’s Esophagus-Associated Neoplasia Using Wide Area Transepithelial Sampling in Conjunction with 4-Quadrant Forceps Biopsies: Final Results from a Multi-Center, Prospective, Randomized Trial

Vennalaganti, Prashanth; Eisen, Glenn; Falk, Gary W.; Gerson, Lauren B.; Goldblum, John R.; Gross, Seth A.; Gupta, Neil; Haber, Gregory B.; Infantolino, Anthony; Iyer, Prasad; Johnson, David A.; Kaul, Vivek; Kothari, Shivangi; Lightdale, Charles J.; Schnoll-Sussman, Felice; Shaheen, Nicholas; Smith, Michael S.; Wang, Kenneth K.; Zhang, Yaxia; Sharma, Prateek

Key Findings: Seattle Protocol FB detected 7 cases of HGD/EAC, 6 of which were also detected by WATS3D with the remaining case reported by WATS3D as IND/LGD. WATS3D found an additional 23 cases of HGD/EAC not detected on FB (12 were reported by FB as IND/LGD, while 11 were reported by FB as NDBE only).

Conclusion: WATS3D found 4.1x more HGD/EAC than Seattle Protocol random biopsies.

Published Clinical Studies 2015

Inter-Observer Agreement among Pathologists Using Wide-Area Transepithelial Sampling With Computer-Assisted Analysis in Patients With Barrett’s Esophagus

Prashanth R. Vennalaganti, MD , Vijay Naag Kanakadandi, MD, Seth A. Gross,MD, Sravanthi Parasa, MD, MPH, Kenneth K. Wang, MD, Neil Gupta , MD, MPH and Prateek Sharma. Am J Gastroenterol, 28 April 2015; doi: 10.1038/ajg.2015.116

Key Findings: The diagnosis of BE and associated dysplasia using the WATS technique has very high inter-observer agreement. This appears to be significantly higher as compared with previously published data using standard histopathology.

Data Presented at AGA/ASGE Presidential Plenary Session 2014

Esophageal Brush Biopsy With Computer-Assisted Tissue Analysis Increases Detection Of Barrett’s Esophagus And Dysplasia In A Multi-Site Community-Based Setting

Seth Gross MD, Vivek Kaul MD, Anthony Infantolino MD, Michael Smith MD

Key Findings: WATS3D with computer-assisted analysis complements standard FB methods to markedly increase detection of BE and dysplasia. This is the largest series reported to date. In light of recent studies and changes to Barrett’s management guidelines, improved dysplasia detection is critical to appropriate management of these pre-cancerous lesions. This study shows that widespread use of WATS3D in community based gastroenterology practices identifies dysplasia missed by FB, leading to improved care for these patients.

Data Presented at American College of Gastroenterology Annual Meeting – 2014

Inter-Observer Agreement Among Pathologists Using the WATS Technique: Wide Area Transepithelial Sampling of Barrett’s Esophagus Using Computer-Assisted Analysis

Prashanth Vennalaganti MD, Vijay Nag Kanakadandi MD, Sravanthi Parasa MD, MPH, S Gross MD, Neil Gupta MD, MPH, Prateek Sharma MD

Key Findings: The diagnosis of Barrett’s esophagus and associated dysplasia using the WATS technique has a very high inter-observer agreement. WATS technique appears to be significantly better inter observer rates compared to previously published data using standard histopathology. This technology represents a significant improvement over current histopathology assessment.

Poster Presented at American College of Gastroenterology Annual Meeting – 2014

Incremental Benefit of Computer-­‐Assisted Brush-­‐Biopsy (WATS3D) Compared to Standard Endoscopic Biopsy for Detection of Barrett’s Esophagus (BE) and Dysplasia: Systematic Review and Meta‐Analysis

Lauren B. Gerson, MD, MSc Mark Rutenberg, Richard Scott

Key Findings: The addition of WATS3D to standard forceps biopsy increases the diagnostic yield for BE and dysplasia in patients undergoing both screening and surveillance.
– The increased yield was highest for patients undergoing screening for BE or post-ablation examinations.
– The number needed to treat (NNT) to detect an additional case of Barrett’s Esophagus ranged from 4-11 based on the 7 available studies.

Posters Presented at ACG 2012

Wide Area Transepithelial Sampling (WATS3D) Improves Detection of Barrett’s Esophagus Following Endoscopic Ablation

Rahul D. Kataria, BS, Michael S. Smith, MD, MBA. Temple University School of Medicine, Philadelphia, PA

Key Findings: WATS3D increased the diagnostic yield from only forceps biopsy by 75% (3/4).

Published Studies 2010

Computer-Assisted Brush-Biopsy Analysis for the Detection of Dysplasia in a High-Risk Barrett’s Esophagus Surveillance Population

Anandasabapathy S, Sontag S, Graham DY, Frist S, Bratton J, Harpaz N, Waye JD. Computer-Assisted Brush-Biopsy Analysis for the Detection of Dysplasia in a High-Risk Barrett’s Esophagus Surveillance Population. Dig Dis Sci. 2011 Mar;56(3):761-6. Epub 2010 Oct 27.

Key Findings: These data suggest that computer-assisted brush biopsy is a useful adjunct to standard endoscopic surveillance regimens for the identification of dysplasia in Barrett’s esophagus.

Computer-Assisted Analysis of Abrasive Transepithelial Brush Biopsies Increases the Effectiveness of Esophageal Screening:A Multicenter Prospective Clinical Trial by the EndoCDx Collaborative Group

Johanson JF, Frakes J, Eisen D; EndoCDx Collaborative Group. Computer-Assisted Analysis of Abrasive Transepithelial Brush Biopsies Increases the Effectiveness of Esophageal Screening: A Multicenter Prospective Clinical Trial by the EndoCDx Collaborative Group. Dig Dis Sci. 2011 Mar;56(3):767-72. Epub 2010 Dec 4.

Key Findings: These results suggest that adjunctive computer-assisted analysis of an abrasive brush biopsy has the potential to substantially improve the detection of Barrett’s esophagus and dysplasia in screening populations.