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WATS3D VA Clinical Evaluation Program   |   Federal Supply Schedule # 36F79721D0050                   REQUEST A MEETING

Protect Our Veterans From Esophageal Cancer

Prioritize Early Detection For A Better Quality of Life

VA-Risk

Infrequently Evaluated

Veterans with multiple risk factors for Barrett’s esophagus (BE) are infrequently evaluated with EGD.1

VA-BE-screening

Not Effectively Identified

Current BE screening guidelines may not effectively identify BE cases in the Veteran population.2

VA-segments

At Higher Risk 

Veterans with longer BE segments are at higher risk and 3X as likely to have missed dysplasia.3

Veterans, especially those exposed to toxic substances, have an increased risk of developing esophageal cancer.

The PACT Act & Military Toxic Exposure

The PACT Act provides Veterans—and their survivors—with the care and benefits they’ve earned and deserve.

  • Congress passed the PACT Act primarily to address and enhance health care and benefits for Veterans exposed to toxic substances during their military service

  • Beginning March 5, 2024, the Act expands and extends eligibility for VA health care for Veterans with toxic exposures and Veterans of the Vietnam era, Gulf War era, and Post-9/11 era.

  • 20 burn pit and other toxic exposure presumptive conditions have been added, so Veterans don’t need to prove that their service caused the condition.

    • Gastrointestinal cancer of any type is one of the 20 presumptive conditions.

    • The VA has implemented regulations under the PACT Act, including screenings for conditions that could be precancerous, especially for Veterans exposed to toxic substances. The PACT Act expands access to VA health care and requires the VA to conduct initial and follow-up toxic exposure screenings at least once every five years for eligible Veterans.

Challenges with Endoscopic Evaluation4

  • Subtle appearance of dysplasia in BE mucosa makes dysplasia challenging to identify.
  • Only 5-10% of the entire BE mucosa is typically sampled.
  • Missed dysplasia detection due to poor adherence to endoscopic guidelines.
  • Industry recognized inter-observer variability among pathologists may lead to inaccurate diagnosis of BE and dysplasia.

AnnualCost-CircleEach case detected in the precancer stage saves $63k-$134k annually.5

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WATS3D-Reg_Logo-Tag_On-White400

WATS3D Is a Diagnostic Solution That Overcomes the Challenges of Current Endoscopic Screening and Surveillance

Backed by 22 published studies and 400,000+ clinical cases, WATS3D has been shown to significantly improve detection of Barrett’s esophagus and dysplasia

The WATS3D Process

Symbol-SampleSample & Ship

Take sample during endoscopy (2-3 minutes) & ship specimen to CDx Diagnostics (prepaid shipping label included).

Symbol2-AIWATS3D AI Platform

CDx Pathologists make diagnoses with assistance of WATS3D AI & EDF technology.

Symbol3-AccessAccess Results

Reports accessible in 5 days or less (from time sample is received by CDx laboratory).

Newly Published Study

 
  • A sub-analysis of this study noted Veterans were 3X as likely to be identified with dysplasia.3
  • Using WATS3D with forceps biopsies (FB) in GERD patients screened for BE confirmed an additional 20% positives.6
  • 91% of gastroenterologists changed patient care plans with positive WATS3D and negative FB.6

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Without WATS3D, 1 in 5 patients
would have been unaware they had Barrett’s.7

WATS3D Clinical Evidence Highlights

WATS3D Effective for Screening 

Adjunctive Use of WATS-3D in Symptomatic GERD Patients Increases Detection of Barrett's Esophagus and Dysplasia.

Nicholas J Shaheen, Robert D Odze, Mendel E Singer, William J Salyers, Sachin Srinivasan, Vivek Kaul, Arvind J Trindade, Amit Aravapalli, Robert D Herman, Michael S Smith, Matthew J McKinley.

American Journal of Gastroenterology
April 18, 2024.

  • The largest WATS3D study to date, with 23,933 symptomatic GERD patients
  • Patients underwent screening with both forceps biopsies and WATS3D
  • WATS3D had an adjunctive yield of 76.5% and an absolute yield of 18.1% for detecting IM that forceps missed
  • Dysplasia was found in 240 patients, with nearly 45% identified only by WATS3D
  • WATS3D influenced the management of over 90% of patients based on findings missed by forceps

WATS3D significantly improves the detection and management of BE, enhancing treatment outcomes for GERD patients

WATS3D for All Segment Lengths

Benefit of Adjunctive Wide Area Transepithelial Sampling with 3-Dimensional Computer-Assisted Analysis Plus Forceps Biopsy Based on Barrett’s Esophagus Segment Length.

Arvind J. Trindade, Robert D. Odze, Michael S. Smith, Vivek Kaul.

Gastrointestinal Endoscopy - 2023

  • Purpose was to evaluate adjunctive yield in short and long segment Barrett’s
  • Patients included were 52% for screening and 48% for Surveillance
  • Overall adjunctive yield of WATS3D were 48% for intestinal metaplasia, and 140% for detection of dysplasia
  • Intestinal metaplasia diagnostic yield in short segment Barrett’s was 60% and in long segment Barrett’s was 23%
  • Dysplasia yield in short segment Barrett’s was 128% and in long segment Barrett’s was 145%

WATS3D is effective at increasing the diagnostic yield of both intestinal metaplasia and associated dysplasia in patients with either short or long segment Barrett’s.

WATS3D for Post-Ablation 

Utility of wide-area transepithelial sampling with 3-dimensional computer-assisted analysis as an adjunct to forceps biopsy sampling in the surveillance of patients with Barrett’s esophagus after endoscopic eradication therapy. 

Scott Corbett, Robert D. Odze, Matthew J. McKinley.

IGIE - December 2022

  • Purpose was to evaluate adjunctive (and absolute) increased yield of WATS3D for detection of residual/recurrent disease after endoscopic eradication therapy
  • The adjunctive yield of IM and dysplasia was 53% and 92%, respectively
  • In patients with no endoscopic evidence of residual/recurrent Barrett’s, the relative yield of WATS3D was 260% for the detection of any IM, and 60% for dysplasia detection

WATS3D is effective at increasing the diagnostic yield of intestinal metaplasia and dysplasia in Barrett’s patients post-ablation.

WATS3D Findings are Real/Progress to Cancer 

Progression of Barrett’s esophagus, crypt dysplasia, and low-grade dysplasia diagnosed by WATS3D: a retrospective analysis. 

Nicholas J. Shaheen, Michael S. Smith, Robert D. Odze.

Gastrointestinal Endoscopy
March 2022

  • WATS3D has demonstrated the ability to detect clinically significant lesions progressing at the same rates as ones found with Forceps Biopsy.
  • Untreated patients that were diagnosed with crypt dysplasia or low-grade dysplasia through WATS3D had a recognized rate of progression to the next stage of progression toward EAC.

WATS3D findings progressed at a similar or higher rate as findings detected by forceps biopsy.

 

WATS3D Finds More HGD/EAC than Forceps 

Increased detection of Barrett's esophagus-associated neoplasia using Wide-Area Trans-epithelial Sampling: A multicenter, prospective, randomized trial. 

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

Gastrointestinal Endoscopy - July 2017

  • Multicenter academic study (16 academic facilities) of 160 patients looking at added yield % of HGD by adding WATS3D in an enriched patient population – referred for BE and/or dysplasia from the community.
  • Forceps identified 7 HGD cases out of 30, WATS identified 29 (23 additional cases missed by forceps).

This demonstrates the superiority of WATS3D as well as the limitations of random FB. 

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Clinical Evaluation Program

  • While over 400K WATS3D cases have been completed to date, this program allows VA facilities to evaluate the clinical utility and additional yield provided by WATS3D to the patients of the VA at a discounted rate from the FSS rate. 
  • CDx’s internal data shows that the Veteran population is at higher risk, and this program is designed to enable healthcare providers with the ability to see the additional disease that WATS3D finds over standard testing methods. 
  • To initiate the WATS3D Clinical Evaluation Program for a site, a quotation for 61 cases will be provided to the purchasing team. Once the PO is approved and received, CDx will provide the 61 kits to the site and coordinate with local team(s) on product training.
  • Once the WATS3D tests are completed, and sent back to the CDx laboratory, results will usually be available to the provider within 5 business days. 
  • Upon completion of the 61st case and based on clinician request, CDx will provide a summary of the findings from the program cases, and with the ability to compare results to forceps biopsy results, provide additional disease yield measurements for this program.

 

Download the VA Clinical Evaluation Brochure (PDF)

From Uncertainty to Clarity

Elevate Veteran Care
with WATS3D

Take the first step towards improving your diagnostic accuracy and patient outcomes for Veterans today.

 

Simply fill out the form or contact us at WATS3D@cdxdiagnostics.com or call (866) 3636-CDX

1. Crowe et al. (2023). Veterans with multiple risk factors for Barrett’s esophagus are infrequently evaluated with upper endoscopy. Dis Esophagus, 36(9), doad007. https://doi. org/10.1093/dote/doad007, 2. Nguyen et al. (2021). Prevalence of Barrett’s esophagus and performance of societal screening guidelines in an unreferred primary care population of U.S. veterans. Gastrointest. Endosc, 93(2), 409–419.e1. https://doi.org/10.1016/j.gie.2020.06.032, 3. Nguyen et al. (2022). Prevalence and Predictors of Missed Dysplasia on Index Barrett’s Esophagus Diagnosing Endoscopy in a Veteran Population. Clin Gastroenterol Hepatol, 20(4), e876–e889. https://doi.org/10.1016/j.cgh.2021.04.008, 4. Iyer et al. (2023). Surveillance in Barrett’s Esophagus: Challenges, Progress, and Possibilities. Gastroenterology. https://doi.org/10.1053/j.gastro.2023.01.031, 5. Sharma et al. (2023). Healthcare Resource Utilization and Costs Among Patients With Gastroesophageal Reflux Disease, Barrett’s Esophagus, and Barrett’s Esophagus-Related Neoplasia in the United States. J. health econ. outcomes res., 10(1), 51–58. https://doi.org/10.36469/001c.68191, 6. Shaheen et al. (2024). Adjunctive Use of WATS-3D in Symptomatic GERD Patients Increases Detection of Barrett’s Esophagus and Dysplasia.Am J Gastroenterol. https://doi.org/10.14309/ajg.0000000000002818.