Veracyte Announces 17 Abstracts Demonstrating Its Decipher Tests’ Leadership in Urologic Cancers to Be Presented at the 2025 ASCO GU Symposium
Veracyte (VCYT) announced that 17 Decipher-focused abstracts will be presented at the 2025 ASCO Genitourinary Cancers Symposium, demonstrating the effectiveness of its Decipher tests in guiding treatment decisions for prostate and bladder cancers. Key findings include the Decipher Prostate test's ability to inform treatment intensification strategies in salvage radiotherapy patients, and the Decipher Bladder test's accuracy in identifying favorable outcomes in bladder cancer patients.
The research presentations highlight the test's market leadership and inclusion in NCCN guidelines. Notable studies include validation of the PORTOS gene expression signature for predicting radiation therapy response, and a large-scale analysis showing Decipher Prostate's robust prognostic performance. The symposium will take place February 13-15 in San Francisco.
Veracyte (VCYT) ha annunciato che 17 abstract focalizzati su Decipher saranno presentati al Simposio ASCO 2025 sui Tumori Genito-Urinarie, dimostrando l'efficacia dei suoi test Decipher nel guidare le decisioni terapeutiche per i tumori della prostata e della vescica. Scoperte chiave includono la capacità del test Decipher Prostate di informare le strategie di intensificazione del trattamento nei pazienti sottoposti a radioterapia salvavita, e l'accuratezza del test Decipher Bladder nell'identificare esiti favorevoli nei pazienti con tumore alla vescica.
Le presentazioni della ricerca evidenziano la leadership di mercato del test e la sua inclusione nelle linee guida NCCN. Gli studi notevoli includono la validazione della firma di espressione genica PORTOS per prevedere la risposta alla radioterapia, e un'analisi su larga scala che dimostra le robuste prestazioni prognostiche di Decipher Prostate. Il simposio si terrà dal 13 al 15 febbraio a San Francisco.
Veracyte (VCYT) anunció que se presentarán 17 resúmenes centrados en Decipher en el Simposio ASCO 2025 sobre Cánceres Genitourinarios, demostrando la eficacia de sus pruebas Decipher en la orientación de decisiones de tratamiento para el cáncer de próstata y de vejiga. Hallazgos clave incluyen la capacidad de la prueba Decipher Prostate para informar sobre estrategias de intensificación del tratamiento en pacientes de radioterapia de rescate, y la precisión de la prueba Decipher Bladder para identificar resultados favorables en pacientes con cáncer de vejiga.
Las presentaciones de investigación destacan el liderazgo en el mercado de la prueba y su inclusión en las guías NCCN. Estudios notables incluyen la validación de la firma de expresión génica PORTOS para predecir la respuesta a la radioterapia, y un análisis a gran escala que muestra el sólido rendimiento pronóstico de Decipher Prostate. El simposio se llevará a cabo del 13 al 15 de febrero en San Francisco.
Veracyte (VCYT)는 2025년 ASCO 비뇨기 종양 심포지엄에서 Decipher 중심의 17개의 초록이 발표될 것이라고 발표했습니다. 이는 전립선암 및 방광암에 대한 치료 결정 안내에 있어 Decipher 테스트의 효과를 입증합니다. 주요 발견으로는 구조 방사선 치료를 받는 환자에게 치료 강화를 위한 전략을 알리는 Decipher Prostate 테스트의 능력과 방광암 환자에게 유리한 결과를 식별하는 Decipher Bladder 테스트의 정확성이 포함됩니다.
연구 발표는 테스트의 시장 리더십과 NCCN 가이드라인에서의 포함을 강조합니다. 주목할 만한 연구로는 방사선 치료 반응 예측을 위한 PORTOS 유전자 발현 서명의 검증과 Decipher Prostate의 강력한 예후 성능을 보여주는 대규모 분석이 포함됩니다. 심포지엄은 2월 13일부터 15일까지 샌프란시스코에서 열릴 예정입니다.
Veracyte (VCYT) a annoncé que 17 résumés axés sur Decipher seront présentés au Symposium ASCO 2025 sur les Cancers Gynécologiques, démontrant l'efficacité de ses tests Decipher dans l'orientation des décisions de traitement pour les cancers de la prostate et de la vessie. Résultats clés incluent la capacité du test Decipher Prostate à informer les stratégies d'intensification du traitement chez les patients en radiothérapie de sauvetage, et l'exactitude du test Decipher Bladder à identifier des résultats favorables chez les patients atteints de cancer de la vessie.
Les présentations de recherche soulignent le leadership sur le marché du test et son inclusion dans les lignes directrices de la NCCN. Des études notables comprennent la validation de la signature d'expression génique PORTOS pour prédire la réponse à la radiothérapie, ainsi qu'une analyse à grande échelle montrant les solides performances pronostiques de Decipher Prostate. Le symposium se déroulera du 13 au 15 février à San Francisco.
Veracyte (VCYT) gab bekannt, dass 17 Decipher-zentrierte Abstracts beim ASCO 2025 Genitourinary Cancers Symposium präsentiert werden, die die Wirksamkeit seiner Decipher-Tests zur Steuerung von Behandlungsentscheidungen bei Prostata- und Blasenkrebs demonstrieren. Wichtige Ergebnisse beinhalten die Fähigkeit des Decipher Prostate-Tests, Strategien zur Behandlungsintensivierung bei Patienten mit Salvage-Bestrahlungstherapie zu informieren, sowie die Genauigkeit des Decipher Bladder-Tests bei der Identifizierung günstiger Ergebnisse bei Blasenkarzinom-Patienten.
Die Forschungsvorträge heben die Marktführerschaft des Tests und dessen Aufnahme in die NCCN-Leitlinien hervor. Bemerkenswerte Studien umfassen die Validierung der PORTOS-Genexpressionssignatur zur Vorhersage der Reaktion auf die Strahlentherapie sowie eine umfassende Analyse, die die robuste prognostische Leistung von Decipher Prostate zeigt. Das Symposium findet vom 13. bis 15. Februar in San Francisco statt.
- Decipher Prostate test achieved highest status among gene expression tests in NCCN guidelines
- 17 research abstracts to be presented, demonstrating strong clinical validation
- Decipher Bladder test shows accuracy in identifying favorable cancer outcomes
- Large-scale study confirms Decipher Prostate test's strong prognostic performance
- None.
Insights
The presentation of 17 research abstracts at ASCO GU represents a significant validation of Veracyte's Decipher platform, with several critical implications for investors:
The Decipher Prostate test's achievement of highest status in NCCN guidelines is particularly noteworthy, as it typically translates to broader insurance coverage and increased clinical adoption. This positioning, supported by multiple Phase 3 trial validations, creates a substantial competitive moat in the prostate cancer diagnostics market.
The research demonstrates three key value drivers:
- Expansion into new clinical applications, including treatment response prediction and risk stratification, which could significantly expand the addressable market
- Validation in bladder cancer, suggesting potential market expansion beyond prostate cancer
- Integration of whole-transcriptome analysis with AI, though initial results suggest the molecular test alone maintains superior prognostic value
The GRID (Genomic Resource for Intelligent Discovery) platform represents an underappreciated asset, enabling continuous innovation and new clinical applications. This research-driven approach creates a virtuous cycle: more clinical evidence leads to broader adoption, generating more data for further innovation.
The breadth of clinical validation, particularly in treatment-decision impacts, positions Veracyte favorably for potential expansion of insurance coverage and clinical adoption. The company's focus on robust clinical evidence generation mirrors the successful playbook used by leading molecular diagnostic companies.
“The scale and scope of data to be presented at the ASCO GU meeting underscore the impact our whole-transcriptome-based Decipher tests are having in treating patients with urologic cancers, and how our GRID, or Genomic Resource for Intelligent Discovery, research tool is helping to advance scientific understanding of these diseases,” said Elai Davicioni, Ph.D., Veracyte’s medical director, Urology. “Our commitment to generating robust clinical evidence with collaborators has led to our market-leading Decipher Prostate test achieving the highest status among gene expression tests in the most recent, and prior, NCCN guidelines.* We look forward to using a similar approach for our Decipher Bladder test in bladder cancer.”
“Clinical rigor and robust evidence generation are important for a molecular test to gain widespread adoption and inclusion in guidelines for helping physicians and their patients with prostate cancer make better-informed treatment decisions,” said Daniel Spratt, M.D., of the University Hospitals Seidman Cancer Center, Case Western Reserve University. “National guidelines have acknowledged the large body of work from randomized Phase 3 trials that have been profiled with Decipher and include the Decipher test as an advanced risk-stratification tool that can aid in shared-decision making for patients.”
Key Decipher-focused findings to be presented at the ASCO GU Symposium are:
Title: |
Decipher Score as a Predictor of Response to Treatment Intensification in the NRG Oncology-RTOG 0534 (SPPORT) Phase III Randomized Post-Prostatectomy Salvage Radiotherapy Trial |
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Presenter: |
Alan Pollack, M.D., Ph.D., University of Miami Health System |
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Format: |
Poster (#K29) |
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Abstract #: |
399 |
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Date/Time: |
Thursday, February 13, 2025; 11:25 a.m.—12:45 p.m. PST |
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Location: |
Level 1, West Hall; On Demand |
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Summary: |
A post-hoc analysis of the NRG Oncology/RTOG 05-34 (SSPORT) Phase 3, randomized trial shows that the Decipher Prostate test may inform treatment intensification strategies in patients undergoing salvage radiotherapy by identifying those who will benefit from pelvic nodal radiation. |
Title: |
A non-coding RNA based classifier for favorable outcomes in clinically organ confined bladder cancer |
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Presenter: |
Yair Lotan, M.D., UT Southwestern Medical Center |
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Format: |
Poster (#G27) |
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Abstract #: |
831 |
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Date/Time: |
Friday, February 14, 2025; 11:30 a.m.—12:45 p.m. PST |
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Location: |
Level 1, West Hall; On Demand |
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Summary: |
Study findings show that the Decipher Bladder test accurately identifies patients whose bladder cancer has a luminal molecular subtype, which is associated with favorable outcomes. Such findings could help clinicians determine which patients are less likely to benefit from intensified therapy. |
Title: |
Gene signature predictor of dose-response to prostate radiation: validation of PORTOS in phase III trials |
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Presenter: |
Shuang Zhao, M.D., University of |
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Format: |
Oral Presentation |
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Abstract #: |
308 |
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Date/Time: |
Thursday, February 13, 2025; 8:00 a.m.—9:40 a.m. PST |
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Location: |
Level 3, Ballroom; Live Stream |
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Summary: |
Analyses of two prospective, randomized, Phase 3 trials (RTOG 01-26 and SAKK 09/10) show that the PORTOS gene expression signature – currently part of the Decipher GRID research tool – predicts which patients will benefit from dose-escalated radiation therapy in both primary and salvage treatment settings. |
Additional notable Decipher-focused presentations include:
Title: |
Decipher Risk Stratification of Radiorecurrent Prostate Cancer: Correlative Analysis of the F-SHARP Trial of Salvage Reirradiation |
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Presenter: |
Abhishek Solanki, M.D., M.S., Loyola University Chicago |
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Format: |
Poster (#L15) |
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Abstract #: |
419 |
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Date/Time: |
Thursday, February 13, 2025; 11:25 a.m.—12:45 p.m. PST |
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Location: |
Level 1, West Hall; On Demand |
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Summary: |
Radiation therapy is increasingly used for patients whose prostate cancer has recurred following initial radiation treatment. This study suggests the Decipher Prostate test can identify patients who are likely to benefit from more radiation alone versus those who may also need further treatment intensification. |
Title: |
Androgen receptor activity in biopsy specimens at initial diagnosis of prostate cancer and correlation with outcomes and treatment response |
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Presenter: |
Nicole Handa, M.D., Northwestern University, Feinberg School of Medicine |
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Format: |
Poster (#L5) |
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Abstract #: |
409 |
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Date/Time: |
Thursday, February 13, 2025; 11:25 a.m.—12:45 p.m. PST |
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Location: |
Level 1, West Hall; On Demand |
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Summary: |
Using the Decipher GRID research tool to assess transcriptome-wide expression data and clinical factors, investigators found that low androgen receptor activity (AR-A) was associated with poor outcomes for prostate cancer patients. They suggest such patients could potentially benefit from post-operative radiation therapy and PARP inhibitors. |
Title: |
Risk Stratification Using the Decipher 22-gene Genomic Classifier (GC) and Digital Pathology Artificial Intelligence (DPAI) in Nearly 10,000 Localized Prostate Cancer Patients |
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Presenter: |
Daniel Spratt, M.D., University Hospitals Seidman Cancer Center, Case Western Reserve University |
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Format: |
Poster (#L4) |
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Abstract #: |
408 |
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Date/Time: |
Thursday, February 13, 2025; 11:25 a.m.—12:45 p.m. PST |
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Location: |
Level 1, West Hall; On Demand |
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Summary: |
This large study found that adding digital pathology artificial intelligence (DPAI) tools to the Decipher Prostate Genomic Classifier did not further improve the molecular test’s prognostic performance. Ongoing research is underway to explore whether there may be specific clinical states where the combination of DPAI and the Decipher test may add meaningful clinical utility. |
“The extensive Decipher-focused data at the 2025 ASCO GU Symposium demonstrate the power of our novel Veracyte Diagnostics Platform, which begins with delivering high-performing tests using a comprehensive, whole-transcriptome approach. This enables additional research, which in turn supports further innovation to help more patients,” said Phillip Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer.
Veracyte’s Decipher team will be at Booth #37 at the 2025 ASCO GU Symposium. More information, including a full list of Decipher-focused abstracts being presented, 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 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 GRID
The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID 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 LinkedIn and 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 Decipher tests to better inform treatment decisions for patients with prostate and bladder cancers, compared to standard approaches, and help drive innovation that will inform the future of urologic cancer care. 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. 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
* 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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Investors:
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619-393-1545
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Source: Veracyte
FAQ
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What did the large-scale study reveal about VCYT's Decipher Prostate test and DPAI?
