Making Prevention Possible

Innovative proprietary preemptive screening technologies from CDx help improve patient outcomes and reduce healthcare costs for payers.

 

 

 

 

 

 

 

Each year, esophageal cancer kills more Americans than cervical cancer and melanoma combined. 

Esophageal Adenocarcinoma (EAC) is one of the most fatal and fastest-growing cancers. 

“By 2025, the prevalence of esophageal adenocarcinoma is expected to increase by 140%.”*


*Ruberstein JH Risk Factors for Barrett’s esophagus. Curr Opin Gatrone

While chronic heartburn (or GERD) is the most common risk factor for developing Barrett’s esophagus, other at-risk groups include:

  • Males

  • Obese patients

  • Tobacco users

  • Those >50 years of age

The cost to payers for screening and surveillance of Barrett's esophagus continues to increase yearly. Yet, the 5-year survival of esophageal adenocarcinoma remains miserable, in part, due to the limitations of the Seattle protocol.

Seattle-Protocol800

WATS3D has become the standard of care when used adjunctively to the Seattle protocol.

The Seattle random forceps biopsy protocol does not reliably detect Barrett’s esophagus or dysplasia, which are precursors to esophageal adenocarcinoma. 

WATS3D-Overcoming-Limitation

WATS3D is the Solution

WATS3D (Wide-Area Transepithelial Tissue Sampling with computer-assisted 3D analysis), when used as an adjunct to standard biopsy sampling,  has been shown to reliably detect unhealthy cells before they develop into cancer.

WATS3D is endorsed for both screening and surveillance of patients with suspected or known Barrett's esophagus , as an adjunct to routine biopsies, in  the recently published Guidelines of the American Society for Gastrointestinal Endoscopy (ASGE).

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Aligned with professional guidelines.*

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ASGE Recommendation: 

 “In patients with known or suspected BE, we suggest using WATS3D in addition to WLE with Seattle protocol biopsy sampling compared with WLE with Seattle protocol biopsy sampling alone”

*ASGE guideline on Barrett’s (GI Endosc 90(3) 2019 page 351)

Why Payers Support WATS3D

enhanced patients outcomes icom

Enhanced Patient Outcomes

EAC is preventable if detected and treated early. WATS3D has demonstrated the ability to improve patient outcomes by having a direct impact on the clinical management in 97% of patients diagnosed with BE, LGD or HGD.



Clinical utility of wide-area transepithelial sampling with three-dimensional computer-assisted analysis (WATS3D) in identifying Barrett’s esophagus and associated neoplasia.
Vivek Kaul, Seth Gross, F Scott Corbett, Zubair Malik, Michael S Smith, Christina Tofani, Anthony Infantolino
Diseases of the Esophagus, July, 01 2020

https://doi.org/10.1093/dote/doaa069

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Improved Population Health

More than half of the US population is now over the age of 50, an age that is at increased risk for developing esophageal adenocarcinoma.  Detecting dysplasia early and treating, it has the potential to reduce the incidence of this deadly disease. The addition of WATS3D per 1,000 patients results in approximately 3 fewer cancers and 3 fewer cancer-related deaths



Wide Area Transepithelial Sampling with Computer-Assisted Analysis (WATS3D) Is Cost-Effective in Barrett’s Esophagus. Screening. Singer ME. Gross S, Kaul V, Smith MS. 449. Digestive Diseases and Sciences: June 23, 2020.

https://doi.org/10.1007/s10620-020-06412-1

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Cost-Effectiveness

WATS3D when used adjunctively to standard forceps biopsy is more cost-effective for Barrett's esophagus screening compared to forceps biopsy alone.  Screening with WATS3D costs an additional $1,219 and produced an additional 0.017 QALYs, for an ICER of $71,395/QALY.



Wide Area Transepithelial Sampling with Computer-Assisted Analysis (WATS3D) Is Cost-Effective in Barrett’s Esophagus. Screening. Singer ME. Gross S, Kaul V, Smith MS. Digestive Diseases and Sciences: June 23, 2020.

https://doi.org/10.1007/s10620-020-06412-1

CPT Coding

The following table shows typical billing codes used for WATS3D procedures.

CPT Code CPT Descriptor Maximum Daily Units
88104 Cytopathology, fluids, washings or brushing, except cervical or vaginal 1
88305 Surgical pathology, gross and microscopic examination 1
88312 Special stain including interpretation and report 1
88361 Morphimetric analysis, tumor immunohistochemistry (e.g., Her2nue, estrogen receptor/progesterone receptor), quantitative or semi-quantitative, each antibody, using computer-assisted technology 4

 

*One kit for each 5cm of at-risk mucosa.

WATS3D-Study-Chart

 

Clinical Studies on the Adjunct Use of WATS3D

Study/Year:

# of Patients:

Study Design:

Study Population:

Main Results:

Smith et al.

Dis of the Esophagus (2018)

12,899

Prospective

Randomized

Community Based

⇪Barrett’s   153%

⇪Dysplasia  242%

Gross et al.

United European Gastroenterol J (2018)

4,203

Prospective

Community Based

⇪Barrett’s 83%

⇪Dysplasia 89%

Vennalaganti et al.

Gastrointest Endosc (2018)

160

16 Med Centers

Prospective

Randomized

Academic Centers

(High Risk)

⇪High-Grade Dysplasia  428%

Anandasabapathy et al.

Dig Dis Sci (2011)

151

Prospective

Academic Centers

⇪Dysplasia 42%

Johanson et al.

Dig Dis Sci (2011)

1,266

Prospective

Randomized

Community Based

⇪Barrett’s 70.5%

⇪Dysplasia 87.5%

 

 

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