New Study Shows Veracyte’s Decipher Bladder Test Predicts Disease Upstaging in Patients with Bladder Cancer
Veracyte (VCYT) announced new data supporting its Decipher Bladder Genomic Subtyping Classifier's effectiveness in improving bladder cancer staging. The study, published in European Urology Open Science, analyzed 226 patients from eight medical centers who underwent radical cystectomy without neoadjuvant chemotherapy.
Key findings showed that 33% of patients experienced pathological upstaging to non-organ-confined disease (19% for NMIBC and 53% for T2 disease). The study revealed that NMIBC patients with non-luminal tumors were more likely to be upstaged to MIBC compared to those with luminal tumors (51% vs. 32%). Additionally, patients with luminal-subtype bladder cancer demonstrated better overall survival based on a 33-month median follow-up.
This research adds to Veracyte's growing clinical evidence supporting its molecular tests in urology, where its Decipher Prostate Genomic Classifier is already the market leader.
Veracyte (VCYT) ha annunciato nuovi dati che supportano l'efficacia del suo Classificatore Genomico di Sottotipizzazione Decipher della Vescica nel migliorare la stadiazione del cancro alla vescica. Lo studio, pubblicato su European Urology Open Science, ha analizzato 226 pazienti provenienti da otto centri medici che hanno subito una cistectomia radicale senza chemioterapia neoadiuvante.
I risultati chiave hanno mostrato che il 33% dei pazienti ha sperimentato un avanzamento patologico verso malattia non confinata agli organi (19% per NMIBC e 53% per malattia T2). Lo studio ha rivelato che i pazienti con tumori non luminali NMIBC avevano una maggiore probabilità di essere classificati come MIBC rispetto a quelli con tumori luminali (51% contro 32%). Inoltre, i pazienti con cancro alla vescica di sottotipo luminale hanno dimostrato una migliore sopravvivenza generale basata su un follow-up mediano di 33 mesi.
Questa ricerca si aggiunge alle crescenti evidenze cliniche di Veracyte a supporto dei suoi test molecolari in urologia, dove il suo Classificatore Genomico Prostatico Decipher è già il leader di mercato.
Veracyte (VCYT) anunció nuevos datos que respaldan la efectividad de su Clasificador de Subtipificación Genómica Decipher de Vejiga en la mejora de la estadificación del cáncer de vejiga. El estudio, publicado en European Urology Open Science, analizó a 226 pacientes de ocho centros médicos que se sometieron a una cistectomía radical sin quimioterapia neoadyuvante.
Los hallazgos clave mostraron que el 33% de los pacientes experimentaron una elevación patológica a enfermedad no confinada a órganos (19% para NMIBC y 53% para enfermedad T2). El estudio reveló que los pacientes con tumores no luminales NMIBC tenían más probabilidades de ser clasificados como MIBC en comparación con aquellos con tumores luminales (51% frente a 32%). Además, los pacientes con cáncer de vejiga de subtipo luminal demostraron una mejor supervivencia general según un seguimiento mediano de 33 meses.
Esta investigación se suma a la creciente evidencia clínica de Veracyte que apoya sus pruebas moleculares en urología, donde su Clasificador Genómico Prostático Decipher ya es el líder del mercado.
Veracyte (VCYT)는 방광암 병기 개선에 있어 Decipher 방광 유전체의 세분화 분류기가 효과적임을 지지하는 새로운 데이터를 발표했습니다. European Urology Open Science에 발표된 이 연구는 신보조 화학요법 없이 근치적 방광적출술을 받은 8개 병원의 226명의 환자를 분석했습니다.
주요 발견에 따르면 환자의 33%가 병리학적 업스테이징을 경험했습니다 (NMIBC의 경우 19%, T2 질환의 경우 53%). 연구 결과, 비루미날 침착세포 암을 가진 NMIBC 환자들이 루미날 종양을 가진 환자들보다 MIBC로 업스테이징될 가능성이 높다는 것이 밝혀졌습니다 (51% 대 32%). 또한, 루미날 하위 유형 방광암 환자들은 33개월의 중앙 추적 조사를 기준으로 더 나은 전체 생존율을 보였습니다.
이 연구는 Veracyte의 분자 테스트를 지지하는 임상 증거가 증가하고 있음을 보여주며, 그들의 Decipher 전립선 유전체 분류기는 이미 시장의 선두주자입니다.
Veracyte (VCYT) a annoncé de nouvelles données soutenant l'efficacité de son Classificateur de Sous-typage Génomique Decipher pour la Vessie dans l'amélioration de la stadification du cancer de la vessie. L'étude, publiée dans European Urology Open Science, a analysé 226 patients de huit centres médicaux ayant subi une cystectomie radicale sans chimiothérapie néoadjuvante.
Les résultats clés ont montré que 33 % des patients ont connu une surstade pathologique vers une maladie non confinée aux organes (19 % pour NMIBC et 53 % pour la maladie T2). L'étude a révélé que les patients NMIBC avec des tumeurs non-luminales étaient plus susceptibles d'être reclassés en MIBC par rapport à ceux avec des tumeurs luminales (51 % contre 32 %). De plus, les patients atteints de cancer de la vessie de sous-type luminal ont démontré une meilleure survie globale basée sur un suivi médian de 33 mois.
Cette recherche s'ajoute aux preuves cliniques croissantes de Veracyte soutenant ses tests moléculaires en urologie, où son Classificateur Génomique Prostatique Decipher est déjà le leader du marché.
Veracyte (VCYT) hat neue Daten veröffentlicht, die die Wirksamkeit seines Decipher Bladder Genomic Subtyping Classifiers zur Verbesserung der Stadieneinteilung von Blasenkrebs unterstützen. Die im European Urology Open Science veröffentlichte Studie analysierte 226 Patienten von acht medizinischen Zentren, die sich einer radikalen Zystektomie ohne neoadjuvante Chemotherapie unterzogen.
Wichtige Ergebnisse zeigten, dass 33% der Patienten eine pathologische Hochstufung erfuhren zu einer nicht organbegrenzt Krankheit (19% für NMIBC und 53% für T2-Krankheit). Die Studie ergab, dass NMIBC-Patienten mit nicht-luminalen Tumoren wahrscheinlicher als MIBC eingestuft wurden als solche mit luminalen Tumoren (51% gegenüber 32%). Darüber hinaus wiesen Patienten mit luminalem Blasenkrebs eine bessere Gesamtab survival basierend auf einem medianen Follow-up von 33 Monaten auf.
Diese Forschung trägt zu Veracytes zunehmenden klinischen Beweisen bei, die seine molekularen Tests in der Urologie unterstützen, wo der Decipher Prostate Genomic Classifier bereits Marktführer ist.
- Study validates Decipher Bladder test's ability to predict disease progression
- Test helps identify patients who may benefit from more intensive treatment
- Builds on company's market leadership in prostate cancer diagnostics
- Demonstrates potential for expanded market opportunities in bladder cancer
- None.
Insights
The new clinical validation study for Veracyte's Decipher Bladder test represents a significant advancement in precision oncology diagnostics. The data demonstrates robust clinical utility in two critical areas: accurate disease staging and treatment selection optimization.
The study's findings are particularly compelling from a commercial perspective:
- The 33% upstaging rate observed highlights a substantial unmet clinical need that Veracyte's test addresses directly
- The ability to identify patients who may benefit from neoadjuvant chemotherapy versus those who won't creates a clear value proposition for both healthcare providers and payers
- The test's integration into Veracyte's established urology franchise, which already includes the market-leading Decipher Prostate test, suggests strong potential for market adoption
This publication strengthens Veracyte's position in the growing precision oncology market, particularly as it builds on their successful strategy in prostate cancer diagnostics. The company's approach of building extensive clinical evidence (now with 85+ publications) has historically supported both reimbursement coverage and clinical adoption. The molecular subtyping capability also provides a competitive moat, as it leverages Veracyte's proprietary whole-transcriptome platform.
From a market perspective, this advancement could accelerate Veracyte's penetration into the bladder cancer diagnostic market, which represents a significant growth opportunity given that bladder cancer is the 6th most common cancer in the United States. The test's ability to influence treatment decisions (particularly regarding expensive chemotherapy) positions it favorably for payer coverage and provider adoption.
Findings Further Expand Company’s Extensive Clinical Evidence In Urologic Cancers
Researchers analyzed data for 226 patients from eight medical centers who underwent radical cystectomy (RC) without neoadjuvant chemotherapy (NAC). The study cohort included 134 patients with high-risk non-muscle-invasive bladder cancer (NMIBC) and 92 patients with muscle-invasive bladder cancer (MIBC) classified as T2, in which the cancer had grown into, but not through, the bladder’s muscle layer. Key findings included:
-
Following RC without neoadjuvant chemotherapy, pathological upstaging to non-organ-confined disease was observed in
33% of patients (19% for NMIBC and53% for T2 disease), demonstrating the challenges in bladder cancer clinical staging. -
Using the Decipher Bladder test to determine each tumor’s molecular subtype, researchers found that NMIBC patients with non-luminal tumors were more likely to be upstaged to MIBC, compared to those with luminal tumors (
51% vs.32% , multivariable p=0.03). -
Patients with luminal-subtype bladder cancer had better overall survival on multivariable analyses (non-luminal vs. luminal adjusted HR 1.67 [
95% CI 1.01-2.78], p=0.05), based on a median follow-up of 33 months.
“Accurate clinical staging in bladder cancer can be challenging, limiting clinicians’ ability to guide treatment decisions for their patients,” said Yair Lotan, M.D., professor of urology and chief of urologic oncology at UT Southwestern Medical Center and corresponding author on the study. “Our findings suggest that molecular subtyping information provided by the Decipher Bladder test can help clinicians better identify which patients may benefit from more-intensive treatment with neoadjuvant chemotherapy and which will not and can thus avoid its toxicity.”
The study comes on the heels of three recent peer-reviewed, published studies1-3 demonstrating the performance and clinical utility of the Decipher Bladder test and its whole-transcriptome approach. The new publication also builds on Veracyte’s extensive body of clinical evidence supporting its molecular tests in urology where its Decipher Prostate Genomic Classifier is the market leader in prostate cancer.
“We are increasing our collaboration efforts with leading clinician-scientists to improve and further personalize bladder cancer care, similar to our approach in prostate cancer which has amassed over 85 publications from analysis of hundreds of thousands of patient transcriptomes,” said Elai Davicioni, Ph.D., medical director, Urology, at Veracyte. “This approach is the lynchpin of our Veracyte Diagnostics Platform, which helps facilitate evidence generation, reimbursement and adoption for our tests. It also provides insights that fuel continued innovation, with the overall goal of supporting physicians to deliver better, more-personalized patient care.”
About Decipher Bladder
The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder test can be found here.
About Decipher Prostate
The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in many dozens of published studies involving more than 100,000 patients. It is the only gene expression test to achieve “Level 1B” evidence status and inclusion in the risk-stratification table in the most recent NCCN® Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit www.veracyte.com and follow the company on X (formerly Twitter) at @veracyte.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to our statements related to the potential for the use of the Decipher Bladder Genomic Subtyping Classifier to help clinicians better determine which patients are more likely to harbor more aggressive disease than suggested by their initial clinical staging following transurethral resection of bladder tumor (TURBT) and better identify which patients may benefit from more-intensive treatment with neoadjuvant chemotherapy and which will not and can thus avoid its toxicity. Forward-looking statements can be identified by words such as: “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed,” "ultimately," and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to the potential impact the Veracyte Diagnostics Platform can have on scientific advancements in cancer and, in turn, patient care. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed on February 29, 2024 and our subsequent Quarterly Reports on Form 10-Q. Copies of these documents, when available, may be found in the Investors section of our website at https://investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.
Veracyte, the Veracyte logo, and Decipher are registered trademarks of Veracyte, Inc., and its subsidiaries in the
1 Hwang MW, et al. Upper tract urothelial cancer (UTUC) genomic profiling and correlation regarding benefit of platinum-based chemotherapy. Explor Target Antitumor Ther. 2024;5(6):1261-1270.
2 Reike MJ, Raggi D, Mercinelli C, et al. Distinct Gene Expression Patterns Identify Patients who Relapse After Neoadjuvant Pembrolizumab and Radical Cystectomy in the PURE-01 Study. Clin Genitourin Cancer. 2024;22(6):102214. doi:10.1016/j.clgc.2024.102214.
3 de Jong JJ, et al. A luminal non-coding RNA-based genomic classifier confirms favourable outcomes in patients with clinically organ-confined bladder cancer treated with radical cystectomy. BJU Int. Published online November 1, 2024. doi:10.1111/bju.16572.
* National Comprehensive Cancer Network. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
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Source: Veracyte, Inc.
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