What CDx Diagnostics does

CDx Diagnostics, Inc. is a Delaware-incorporated specialty diagnostics company headquartered in Suffern, New York, with 101-250 employees. Founded prior to 2012, the company has developed and commercialized WATS3D (Wide-Area Transepithelial Sampling with 3D Analysis), an AI-powered diagnostic platform designed to detect pre-cancerous cells in the esophagus and oral cavity. The platform combines a specially designed abrasive brush that collects wide-area, full-thickness transepithelial tissue specimens, 3D computer-assisted tissue analysis synthesizing over 100 one-micron optical slices into a single 3D image, and a proprietary neural network (originally developed from U.S. Strategic Defense Initiative missile defense technology) that selects suspicious areas for pathologist review. Analysis is performed in CDx's CLIA-certified, CAP-accredited, New York state-licensed clinical laboratory.

The company's business model is a per-test laboratory fee reimbursed by commercial payors, Medicare/Medicare Advantage, and federal healthcare channels. WATS3D is covered as an in-network procedure under contracts reaching 73 million lives (~20% of US population) including BCBS of Massachusetts, BCBS of South Carolina, BCBS Kansas City, Highmark, HMSA, and Avalon Healthcare Solutions, plus a GSA Federal Supply Schedule contract serving 12.5 million veterans and active-duty members. Go-to-market combines a sales-led field force targeting GI practices and academic medical centers with channel partnerships via payors and government, supported by direct-to-patient demand generation through a Physician Finder tool and Patient Financial Assistance Program.

The company has processed over 400,000 WATS3D procedures across 10+ years of clinical use, with FDA Breakthrough Device Designation granted in July 2025 and five major GI society endorsements (ASGE, SAGES TAVAC, AFS, AGA). The product portfolio includes WATS3D (core), OralCDx (oral cancer brush biopsy), and EndoCDx (pipeline endoscopic diagnostic), with an R&D pipeline targeting cancers of the throat, bile duct, liver, pancreas, stomach, and IBD-affected colon. CDx is backed by Galen Partners (growth equity).

Name

CDx Diagnostics

Legal name

CDx Diagnostics, Inc.

Website

https://cdxdiagnostics.com

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

101–250 employees

Short description

CDx Diagnostics is a specialty AI-powered diagnostics company that developed WATS3D, an AI-driven platform for detecting pre-cancerous cells in the esophagus and oral cavity, serving gastroenterologists, endoscopists, GI pathologists, and commercial/federal payors across the United States.

Ownership category

akta.pro rank

Product category

Specialty cancer diagnostics (esophageal and oral precancer detection)

NAICS

Medical and Diagnostic Laboratories (62151), Medical and Diagnostic Laboratories (6215), Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy) (HLAAAMAB)

akta.pro secondary industries

Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF), Anatomic Pathology (Histopathology & Cytopathology) (HLAFAMAA)

Keywords

• AI digital pathology
• Esophageal cancer diagnostics
• Barrett's esophagus screening
• Brush biopsy testing
• Specialty clinical laboratory

Headquarters

HQ city

Suffern

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. WATS3D Per-Test Lab Diagnostic Fee: Per-procedure reimbursement from commercial payors, Medicare and Medicare Advantage plans, and patients. WATS3D is billed as a covered benefit under 73 million covered lives across contracted insurers including BCBS of Massachusetts, BCBS of South Carolina, BCBS Kansas City, HMSA, Highmark plans and Avalon. Self-pay/financial assistance available for uninsured patients.
2. Federal Government Lab Services (GSA): Per-test revenue under Veterans Affairs Federal Supply Schedule (VA FSS) Contract #36F79721D0050, providing WATS3D to VA hospitals, Department of Defense, Indian Health Services and federal prisons, reaching 12.5 million veteran and active-duty members at the best commercial rate.
3. EndoCDx and R&D Pipeline Future Tests: Future pipeline of CDx platform applications to prevent cancers of the throat, bile duct, liver, pancreas, stomach, and surveillance for dysplasia of the colon in patients with IBD — extending the per-test lab fee model to new indications.

Pricing tiers

Go-to-market motion6 records

Distribution channels5 records

Marketing channels9 records

Core offering

CDx Diagnostics operates a CLIA-certified specialty clinical laboratory that performs the proprietary WATS3D (Wide-Area Transepithelial Sampling with 3D Analysis) test, an AI-powered diagnostic service that uses a specially designed brush to collect wide-area, full-thickness esophageal tissue specimens and applies a neural-network 3D computer-assisted analysis to detect Barrett's esophagus and precancerous cells missed by standard forceps biopsy. The portfolio also includes the OralCDx brush biopsy test for oral precancer detection and the EndoCDx endoscopic diagnostic, with services delivered to gastroenterology practices, hospitals, payors and federal healthcare facilities on a per-procedure reimbursed basis.

Product overview

CDx Diagnostics is a specialty diagnostics company offering a platform-plus-modules architecture centered on its proprietary AI-powered tissue analysis and 3D imaging platform. The flagship product is WATS3D (Wide-Area Transepithelial Sampling with 3D Analysis), an AI-powered diagnostic system for esophageal cancer prevention that uses a specially designed brush to collect wide-area, full-thickness transepithelial tissue specimens which are then processed through 3D computer-assisted analysis and AI neural network identification of suspicious cells, with final review by trained GI pathologists in the company's CLIA-certified laboratory. OralCDx is a complementary brush biopsy test for oral cancer detection, and EndoCDx is referenced in the navigation as a related endoscopic diagnostic offering. The platform is supported by in-house laboratory services, pathology partnership programs, physician finder tools, patient financial assistance programs, and educational resources (Patient Pocket Guide, Brochure). Recent pipeline initiatives include applying the next-generation CDx diagnostic platform to prevent cancers of the throat, bile duct, liver, pancreas, stomach, and IBD-affected colon.

Differentiator

Problem solved

Functional benefit

Brands

• WATS3D: Wide Area Transepithelial Sampling with 3D Analysis - AI-powered diagnostic platform for detection and surveillance of Barrett's esophagus and esophageal dysplasia.
• OralCDx
• EndoCDx

Products and services

• WATS3D WATS3D (Wide-Area Transepithelial Sampling with 3D Analysis) is an AI-powered diagnostic test that uses a specially designed brush to collect a wide-area, full-thickness transepithelial tissue sample from the esophagus during upper endoscopy. The specimen is processed in CDx's CLIA-certified laboratory through 3D computer-assisted analysis with an AI neural network that highlights suspicious cells for review by trained GI pathologists, significantly increasing detection of Barrett's esophagus and esophageal dysplasia compared with standard forceps biopsy.
• OralCDx OralCDx is a brush biopsy test for oral cancer detection and prevention, designed to identify precancerous changes in the oral cavity. The test uses a specially designed brush (LongBrush) to collect tissue samples that are analyzed for early detection of oral precancerous lesions.
• EndoCDx EndoCDx is a related endoscopic diagnostic offering in CDx Diagnostics' portfolio, referenced in the site's navigation alongside WATS3D and OralCDx as an endoscopic-based diagnostic product for the company's R&D and product pipeline.
• CDx Diagnostics Laboratory Services Diagnostic assessments and laboratory analysis services performed at CDx Diagnostics' CLIA-certified, CAP-accredited, New York state-licensed clinical laboratory in Suffern, NY. Includes tissue specimen processing, 3D imaging, AI-powered analysis and pathologist review for WATS3D and related tests.
• WATS3D Patient Pocket Guide & Patient Brochure Patient-facing educational materials including a WATS3D Patient Pocket Guide and WATS3D Patient Brochure that help patients and doctors discuss the benefits of WATS3D during upper endoscopy for managing Barrett's esophagus and chronic heartburn.
• Patient Financial Assistance Program Financial assistance program that may reduce patient responsibility based on financial need, available with online application forms in English and Spanish and support from Billing Care Specialists at (800)-352-8619.

Named customers17 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature7 records

Partnerships

Ten partnerships are on record, tiered flagship, minor and core.

• American Gastroenterological Association (AGA) and Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)flagshipStrategic or Co-development Partner · 2 May 2025Collaborative study with Dr. Michael Smith, Dr. Vivek Kaul, Mendel Singer Ph.D., and Dr. Robert Odze selected for podium presentation at DDW 2025 (May 2, 2025), advancing understanding of WATS3D-detected lesion progression risk. WATS3D included in AGA Clinical Practice Update (2022) and SAGES TAVAC analysis (2020).
• Dr. Sidney Olefson (Prima CARE, Massachusetts/Rhode Island)minorStrategic or Co-development Partner · 25 March 2025Dr. Sidney Olefson of Prima CARE developed an alternative WATS3D specimen acquisition technique (announced March 25, 2025) that enhances cellular adequacy for AI and pathologist analysis. CDx highlighted this innovation as an important evolution of the WATS3D test platform.
• Avalon Healthcare SolutionscoreChannel Partner/ Reseller/ Distributor · 14 June 2022CDx signed an agreement with laboratory benefits management provider Avalon Healthcare Solutions (Tampa, FL) on June 14, 2022, making CDx an in-network specialty anatomic pathology laboratory for Avalon's client BlueCross BlueShield of South Carolina and 565,000 commercial and Medicare Advantage members.
• Highmark Blue Cross Blue Shield (Delaware, Pennsylvania, West Virginia)flagshipChannel Partner/ Reseller/ Distributor · 17 November 2021Highmark BCBS plans in Delaware, Pennsylvania, and West Virginia designated WATS3D as medically necessary on November 17, 2021, covering more than 3.6 million Highmark members. CDx subsequently joined the Commercial and Medicare networks effective May 2022. Brought total CDx-contracted health plan membership to 36 million at that time.
• Blue Cross Blue Shield of Kansas CitycoreChannel Partner/ Reseller/ Distributor · 9 March 2021BCBS of Kansas City granted WATS3D a positive medically necessary designation effective March 9, 2021, covering 611,000 members across Kansas and Missouri. Fifth organization to add WATS3D to its benefits in the prior quarter.
• BlueCross BlueShield of South CarolinacoreChannel Partner/ Reseller/ Distributor · 26 January 2021WATS3D deemed medically necessary by BCBS of South Carolina (January 26, 2021), covering over 1.2 million members. Subsequently joined Avalon Healthcare Solutions in-network lab network in June 2022 covering 565,000 commercial and Medicare Advantage members.
• U.S. Federal Government (Veterans Administration, Department of Defense, Indian Health Services, Federal Prisons)flagshipChannel Partner/ Reseller/ Distributor · 15 December 2020CDx awarded GSA Contract #36F79721D0050 on December 15, 2020, providing WATS3D through the Veterans Affairs Federal Supply Schedule (VA FSS) to VA hospitals, Department of Defense, Indian Health Services and federal prisons. Gives 12.5 million veteran and active-duty members access to WATS3D at the best commercial rate.
• Hawaii Medical Service Association (HMSA)coreChannel Partner/ Reseller/ Distributor · 11 August 2020CDx contracted with HMSA (largest insurer in Hawaii, BCBS licensee) effective August 11, 2020, making WATS3D available to all 800,000 members and designated medically necessary per ASGE guidelines.
• Blue Cross Blue Shield of MassachusettscoreChannel Partner/ Reseller/ Distributor · 21 January 2020CDx Diagnostics contracted as in-network provider with BCBS of Massachusetts effective January 21, 2020, covering nearly 3 million members statewide. WATS3D designated as medically necessary for the screening and surveillance of Barrett's esophagus under this contract.
• American Society for Gastrointestinal Endoscopy (ASGE)flagshipStrategic or Co-development PartnerWATS3D included in the ASGE Standards of Practice Committee's guideline for the screening and surveillance of Barrett's esophagus (September 4, 2019). Provides ongoing clinical practice validation and inclusion as standard of care in published ASGE Guidelines.

Scale indicators25 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Mauna Kea Technologies: Cellvizio optical biopsy platform enables in-vivo real-time cellular imaging during endoscopy, competing directly with WATS3D in Barrett's esophagus and esophageal cancer screening. Both target the same GI workflow and reimbursement pathway as adjuncts or alternatives to forceps biopsy.
• NinePoint Medical: NvisionVLE optical coherence tomography (OCT) imaging system used during upper endoscopy for Barrett's esophagus surveillance. Competes with WATS3D by offering real-time volumetric tissue imaging that could reduce reliance on physical tissue sampling and external lab analysis.
• Cernostics (acquired by Alpine Immune Sciences): Was a direct competitor in tissue-based diagnostics for Barrett's esophagus risk stratification (TissueCypher), providing a similar lab-based AI-on-tissue approach to predicting progression to esophageal cancer. Acquired by Alpine Immune Sciences in 2022, but the technology represents a directly comparable prior peer.

Emerging players

• Paige.AI: AI-powered digital pathology company (FDA-authorized prostate cancer detection; expanding into other tissue types). While currently focused on prostate and other solid tumors rather than BE, Paige's AI pathology approach is architecturally comparable to WATS3D and could expand into GI applications.
• Ibex Medical Analytics: AI-powered cancer diagnostics platform deployed in pathology labs worldwide, with FDA-cleared products for breast and prostate cancer detection. Shares the AI-on-histopathology model with WATS3D and represents a potential entrant into the Barrett's esophagus and GI surveillance market.
• PathAI: AI pathology company partnering with pharmaceutical and diagnostic companies to develop computational pathology products. Operates in the same AI digital pathology space as WATS3D with adjacent oncology applications and could enter GI pathology over time.

Broad incumbents

• NeoGenomics: Specialty oncology laboratory offering comprehensive molecular and anatomic pathology services, including GI cancer testing. As a broad specialty lab with established payor contracts and a CLIA-certified infrastructure, NeoGenomics could expand into AI-augmented BE/dysplasia testing competing with WATS3D.
• Exact Sciences: Cancer screening and diagnostics company (Cologuard for CRC screening) with established commercial lab, payor contracts, and direct-to-consumer marketing infrastructure. Could expand from CRC into esophageal cancer screening, overlapping with WATS3D's screening-of-pre-cancer positioning.
• Medtronic (GI Solutions / Barrx): Owns the Barrx radiofrequency ablation system for treating Barrett's esophagus. As the dominant player in BE management downstream of diagnosis, Medtronic is a natural strategic partner - or competitor if it bundles WATS3D-alternative diagnostics with its ablation franchise.
• Pentax Medical (HOYA): Endoscope manufacturer developing AI-enhanced endoscopy (i-scan, Optical Enhancement) and exploring AI-powered lesion detection in GI. Provides an OEM/embedded route through which competing AI diagnostic capabilities could be bundled with the endoscopy hardware itself, threatening standalone platforms like WATS3D.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/cdxdiagnostics
• YouTubeyoutube.com/channel/UCs_VO2JtJiOiPAApdQDCkEg
• Facebookfacebook.com/CDx-Diagnostics-193544448227452
• LinkedInlinkedin.com/company/cdx-diagnostics

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds1 record

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CDx Diagnostics