Esophageal Tests (AI)

 Chat GPT 5 (it used its slow answer mode, 3 min 40 sec)

Seveal genomics companies in the US make LDT genomic tests for esophageal dysplasia prognosis or severity. What are they. They tend to have limited insurance coverage.

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Here are the main U.S. players with LDTs aimed at Barrett’s esophagus (BE) / esophageal dysplasia risk or severity—and, as you noted, most have thin/patchy coverage:

• Castle Biosciences — TissueCypher® Barrett’s Esophagus test (PLA 0108U). An AI-driven tissue systems pathology assay on FFPE biopsies to predict progression risk (NDBE/IND/LGD → HGD/EAC). It has CMS ADLT status (payment category) but coverage remains inconsistent across payers. (ir.castlebiosciences.com, Nasdaq)

• Previse (Capsulomics) — ESOPREDICT® (PLA 0398U). A DNA methylation classifier on FFPE biopsies that reports risk of progression to HGD/EAC; company was acquired by Castle in 2025. Many commercial policies still list it as investigational/non-covered. (AAPC, Previse, BCBS Michigan)

• Lucid Diagnostics — EsoGuard® (PLA 0114U). A non-endoscopic esophageal DNA methylation test (balloon collection + methylation panel) for detection across the BE–dysplasia–EAC spectrum; commercial coverage just began at a regional BCBS plan (Mar 2025), and MolDX has scheduled a multi-MAC CAC meeting on Sep 4, 2025 for LCD reconsideration (i.e., no MolDX coverage yet). (PR Newswire, Lucid Diagnostic Investor Relations)

• Interpace Diagnostics — BarreGEN®. A genomic instability / mutational load assay (PathFinderTG platform) to stratify BE progression risk. Interpace announced it stopped accepting BarreGEN specimens May 30, 2025; historically coverage was very limited. (Interpace Biosciences®, Inc., barregen.com)

• Cytogenetic “genomic” adjuncts (FISH-based) from reference labs — e.g., NeoGenomics’ NeoSITE™ BE FISH and Genesis/Pathnostics BE FISH panels (probes such as MYC, p16/CDKN2A, HER2, 20q13), marketed to help identify higher-risk BE from brushings or biopsy. These are available but typically not covered as risk classifiers by major plans. (NeoGenomics, Inc., Genesis Labs)

Why coverage is “limited”

• MolDX LCD L39256 (Upper GI molecular testing) remains a non-coverage policy, now under reconsideration (CAC 9/4/2025). Until/unless that changes, Medicare coverage in MolDX regions is generally no for molecular BE detection/risk tests like EsoGuard/ESOPREDICT. (CMS, Palmetto GBA)

• Multiple commercial payers explicitly classify these tests (TissueCypher, ESOPREDICT, EsoGuard) as investigational/not medically necessary in current policies. (providencehealthplan.com, BlueShieldCA, Blue Cross Blue Shield of Rhode Island)

If you want, I can map who covers what by MAC/plan (MolDX vs. NGS/JN/JK/JL, plus top commercial policies) and tie each test to its current code & price point so you’ve got an at-a-glance grid for payer conversations.

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I think the EsoGUARD company LUCID makes a device that is FDA cleared and a LDT test that is not FDA reviewed.   Can you pull the names of each.

You're absolutely right about the dual nature of Lucid Diagnostics' offerings. Here's the breakdown:

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Names of Each Product

1. FDA-cleared device

• EsoCheck™ Cell Collection Device: This is a swallowable balloon capsule catheter used to collect surface cells from the esophagus during a brief, non‑endoscopic office procedure. It is FDA 510(k) cleared for the collection and retrieval of surface esophageal cells in adults (and adolescents aged 12 and older, per updated indications) (sec.gov).

2. Laboratory-Developed Test (LDT)

• EsoGuard® Esophageal DNA Test: This is an LDT performed on the samples collected by EsoCheck. It is a bisulfite-converted next‑generation sequencing (NGS) DNA methylation assay, analyzing 31 methylation sites across two genes (VIM and CCNA1). It is not FDA reviewed or approved, instead commercialized under CLIA/CAP certification as a Laboratory Developed Test (sec.gov).

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Summary Table

Product Name	Type	FDA Status
EsoCheck™	Cell Collection Device	FDA 510(k) cleared
EsoGuard®	DNA Methylation Assay (LDT)	LDT (no FDA review)

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So indeed, the EsoCheck™ device is FDA-cleared, while the EsoGuard® test is offered as an LDT under regulatory enforcement discretion.