Decipher Bladder Genomic Classifier

Casandra

Casandra Test Code VE90742Version 1 (DRAFT)

Performing Lab

Lab VeracyteLab Test ID N/A

Decipher Bladder Genomic Classifier

Clinical Use

Use

The Decipher Bladder Genomic Classifier is a novel molecular subtyping tool that facilitates personalized treatment decisions in bladder cancer. It classifies bladder tumors into five molecular subtypes, providing actionable insights that guide treatment plans. It's specifically designed for patients diagnosed with bladder cancer to assess and predict the molecular profile of their tumors, offering information about potential responses to neoadjuvant chemotherapy (NAC) and other treatment intensities. The classifier aids in predicting the risk of cancer upstaging to non-organ confined disease, crucial for planning surgical interventions.

Special Instructions

The Decipher Bladder test utilizes whole-transcriptome analysis paired with machine-learning algorithms to deliver its insights. It's important for physicians to ensure that the appropriate patient specimens, specifically bladder tumor specimens, are collected for accurate subtyping. As it is a laboratory-developed test (LDT), all testing is centralized within Veracyte’s certified labs, ensuring standardized processing and analysis.

Limitations

The test is intended for use within the United States under the constraints of existing medical regulations, as it has not received FDA clearance or approval. Its utility is primarily diagnostic and prognostic, without direct therapeutic interventions. The classifier provides subtype classification, which should be integrated into broader clinical assessments and not used in isolation for treatment decisions. Its predictive value is supported by peer-reviewed studies; however, outcomes may vary, and results must be interpreted by qualified healthcare professionals familiar with comprehensive patient histories and concurrent diagnostic data.

Test Details