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 recurrence monitoring, 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.