TEST:

Decipher Bladder Test

This study validates the performance of the GC for identifying UCs with a luminal favourable subtype, harbouring less aggressive tumour biology.

For the remaining three patients, all were treated with platinum-based chemotherapy for eventual metastatic disease but all three showed progressive disease with limited overall survival, highlighting their aggressive course. The non-luminal subtype and lack of FGFR alteration may partly explain the poor overall outcomes while the real-world benefit of next generation sequencing for clinical use in UTUC patients require further clarification in a larger cohort study.

P=N/A; N=165 --> 2 | Trial completion date: Feb 2027 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Feb 2025 --> May 2024; Low enrollment

"Veracyte...announced that data from 14 presentations at AUA 2024, the annual meeting of the American Urological Association, show that the Decipher Prostate and Decipher Bladder Genomic Classifiers provide better prognostic information for patients with prostate and bladder cancer, compared to standard approaches. They also show that the research-use-only Decipher GRID (Genomic Resource for Intelligent Discovery) tool is helping to advance scientific understanding of these diseases. The findings were presented during the conference taking place May 3-6 in San Antonio."

"Veracyte, Inc...today announced that nine abstracts focused on its Decipher Prostate and Decipher Bladder Genomic Classifiers will be presented at AUA 2024, the annual meeting of the American Urological Association, taking place May 3-6 in San Antonio. Studies to be presented include those that evaluate the clinical utility of the company’s Decipher tests in guiding treatment decisions for patients with prostate or bladder cancer. Other presentations will explore new insights into these cancers’ underlying biology, which researchers derived through use of Veracyte’s whole-transcriptome-based Decipher GRID research tool."

Application of a lncRNA-based classifier to two cystectomy cohorts revealed that FGFR3+ patients with cT1 disease have excellent outcomes after RC, suggesting these less aggressive tumors are both organ-confined and readily cured with surgery alone. These findings represent a first step towards identifying cT1 patients with less favorable biology that may warrant systemic treatment before radical surgery.

Molecular subtyping suggests that luminal tumors harbor a less aggressive disease state reflected by lower rates of upstaging compared to non-luminal tumors. Critically, luminal tumors in the cT2 population showed a significantly improved outcomes compared to non-luminal tumors, even in the absence of systemic chemotherapy.

NGS showed LOH - 21.01% and ATM truncation in 2 patients with prolonged responses to avelumab maintenance immunotherapy and 2 patients with CDK2A/2B loss with prolonged survival (mOS = 16.8 mos)... Results do not identify a specific NGS signature or subtype signature that predicts response to chemotherapy in the neoadjuvant or metastatic setting though receipt of chemotherapy appears to clinically affect outcomes in this small sample of UTUC patients. Further studies are needed to identify specific molecular signatures that would predict responses to therapy.

"Veracyte, Inc...announced today that seven abstracts highlighting new data from studies of the company’s Decipher urologic cancer tests will be presented at the American Urological Association (AUA) Annual Meeting, taking place April 28-May 1, 2023, at McCormick Place in Chicago. The abstracts include findings from two separate, large-scale studies that reinforce the real-world clinical utility of the company’s Decipher Prostate Genomic Classifier, which helps inform treatment decisions for men with prostate cancer."

Using a composite biomarker approach of blood-based CTC status and molecular subtyping, we identified a biologically distinct subgroup of MIBC with favorable prognosis after RC-only, validating the performance of a previously developed lncRNA based FGFR3+ classifier. Clinical trials which withhold NAC from CTC-negative, FGFR3+ MIBC patients are warranted.

"Veracyte, Inc...announced today that three abstracts highlighting new data on the genomic underpinnings of prostate and bladder cancers will be presented at the American Urological Association Annual Meeting, taking place May 13-16, 2022, in New Orleans. The findings are derived from analyses of the Decipher GRID, a database that contains genomic profiling information from clinical samples used in the development and commercial application of the Decipher Prostate and Decipher Bladder tests."

P=N/A | "Our data suggest that in MIBC with secondary variant, the urothelial component can demonstrate an expression profile that closely resembles the variant component."