TAGMe^™ for Urothelial Cancer Recurrence Monitoring

FDA Breakthrough Device for Early and Non-Invasive Urothelial Cancer Recurrence Monitoring

Overview

TAGMe™ (Tumor Aligned General Methylated Epiprobe) is a proprietary DNA methylation–based assay designed for non-invasive detection and longitudinal monitoring of urothelial carcinoma (UC) using urine samples.

Built on advanced epigenetic marker discovery and high-throughput methylation quantification, TAGMe enables earlier detection, improved sensitivity, and dynamic monitoring of recurrence, addressing the critical unmet need in post-treatment surveillance.

TAGMe DNA Methylation Detection Kits (qPCR) for Urothelial Cancer are CE-marked products for In Vitro Diagnostic Use. The TAGMe DNA Methylation Detection Kits (qPCR) for Urothelial Cancer kit is not FDA-cleared.

Clinical Need

Urothelial carcinoma is characterized by:

• High recurrence rates (up to 50–70%)

• Requirement for frequent lifelong surveillance

• Heavy reliance on cystoscopy, which is:

  • Invasive and uncomfortable

  • Operator-dependent

  • Cost-intensive with repeated procedures

Urine cytology, while non-invasive, suffers from low sensitivity, especially for early-stage disease

There is a clear clinical demand for a non-invasive, sensitive, and scalable monitoring solution.

TAGMe has been granted U.S. FDA Breakthrough Device Designation for the detection and monitoring of urothelial carcinoma.

This designation is awarded to technologies that:

• Provide more effective diagnosis or monitoring of life-threatening diseases

• Address unmet clinical needs

• Demonstrate potential for significant clinical advantage

Implications:

• Priority interaction and guidance from FDA

• Accelerated development and review pathway

• Strong validation of clinical and technological innovation

This positions TAGMe as a next-generation standard candidate in non-invasive urothelial cancer surveillance

(Breakthrough Device Designation does not mean FDA clearance or approval)

Technology Platform

TAGMe™ Epigenetic Marker System

• Derived from genome-wide methylation discovery (GPS technology)

• Represents a pan-cancer epigenetic marker database

• Enables:

  • Tumor-specific signal detection

  • High signal-to-noise discrimination

  • Early-stage tumor identification

Bisulfite-Free Me-qPCR Platform

Unlike conventional methylation assays, TAGMe utilizes a bisulfite-free methylation detection approach, enabling:

• Faster workflow (≈ 4.5 hours total)

• Higher throughput (up to 280+ samples/day/operator)

• Reduced DNA degradation

• Simplified laboratory workflow

Clinical Performance

Overall Performance

• Sensitivity: ~85%

• Specificity: ~94%

Compared to Urine Cytology

• TAGMe: 85.0% sensitivity

• Cytology: 23.8% sensitivity

Early-Stage Detection

Carcinoma in situ (Tis): 100% sensitivity (10/10)

Strong performance in non-muscle invasive bladder cancer (NMIBC) — the key population for recurrence monitoring.

Recurrence Monitoring Capability

TAGMe is a longitudinal monitoring system:

Recrudesce monitoring model—Early prediction of cancer recurrence

Dynamic Quantitative Monitoring

• Provides continuous methylation score tracking over time

• Enables:

  • Early recurrence detection

  • Risk stratification (negative → weak → high positive)

  • Treatment decision support

Dynamic monitoring——Solution for full process of UC

Early Detection vs. Cystoscopy

• Detects recurrence 3–15 months earlier than cystoscopy

Clinical Utility

• Identify recurrence earlier

• Reduce unnecessary invasive procedures

• Optimize follow-up intervals

• Improve patient compliance

Workflow & Sample Handling

• Sample type: Urine (30 mL, random or morning sample)

• Storage: Room temperature up to 7 days

• Total turnaround time: ~3 hours (PCR-based workflow)

Simple Workflow

1. Urine collection

2. DNA extraction

3. Me-qPCR detection

4. Automated analysis & report

Clinical Applications

TAGMe supports a full continuum of UC management:

1. Recurrence Monitoring (Primary Use Case)

• Post-TURBT surveillance

• High-frequency longitudinal testing

• Early recurrence detection

2. Adjunct to Cystoscopy

• Reduce unnecessary procedures

• Improve diagnostic confidence

3. Treatment Response Monitoring

• Evaluate surgery or chemotherapy efficacy

4. Risk Stratification

• Identify high-risk patients requiring closer follow-up

Patient-Centered Advantages

• Non-invasive (urine-based)

• High compliance for repeated testing

• At-home or clinic collection

• Reduced procedural burden

Laboratory & Commercial Advantages

• High-throughput compatible with

  CLIA labs / LDT model

• Short turnaround time → supports

  rapid clinical decision-making

• Lower operational complexity vs. bisulfite sequencing

• Scalable for

  central lab or distributed testing models

Ordering Info:

TAGMe DNA Methylation Detection Kits (qPCR) for Urothelial Cancer kit is a CE marked product, and for In Vitro Diagnostic Use.

TAGMe DNA Methylation Detection Kits (qPCR) for Urothelial Cancer kit is not FDA-cleared.

Reference:

1. Yang Z, Chen Q, Dong S, Xu P, Zheng W, Mao Z, Qian C, Zheng X, Dai L, Wang C, Shi H, Li J, Yuan J, Yu W, Xu C. Hypermethylated TAGMe as a universal-cancer-only methylation marker and its application in diagnosis and recurrence monitoring of urothelial carcinoma. J Transl Med. 2024 Jul 2;22(1):608. doi: 10.1186/s12967-024-05420-3. PMID: 38956589; PMCID: PMC11218302.