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New Data at ASCO GU Show Power of Veracyte’s Decipher Tests to Improve Patient Care and Its GRID Tool to Advance Prostate and Bladder Cancer Research

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Veracyte (VCYT) presented new data at the 2025 ASCO Genitourinary Cancers Symposium demonstrating the effectiveness of its Decipher Prostate and Bladder tests in guiding cancer treatment. Key findings from 17 Decipher-focused abstracts showed that the Decipher Prostate Genomic Classifier can help identify patients who will benefit from pelvic nodal radiation therapy, while the Decipher Bladder test accurately identified less aggressive cancer cases based on molecular subtypes.

Additionally, research using Veracyte's Decipher GRID tool validated the PORTOS signature's ability to predict patient response to different radiation therapy dosages. The study, also published in Annals of Oncology, analyzed data from two Phase 3 trials, showing that patients with higher PORTOS scores significantly benefited from increased radiation doses in both salvage and definitive radiotherapy settings.

Veracyte (VCYT) ha presentato nuovi dati al Simposio ASCO 2025 sulle Cancers Genitourinarie, dimostrando l'efficacia dei suoi test Decipher per Prostata e Vescica nel guidare il trattamento del cancro. I risultati chiave di 17 abstract focalizzati su Decipher hanno mostrato che il Classificatore Genomico per la Prostata Decipher può aiutare a identificare i pazienti che trarranno beneficio dalla radioterapia per i linfonodi pelvici, mentre il test Decipher per la Vescica ha identificato con precisione i casi di cancro meno aggressivi basati su sottotipi molecolari.

Inoltre, la ricerca utilizzando lo strumento Decipher GRID di Veracyte ha convalidato la capacità della firma PORTOS di prevedere la risposta dei pazienti a diverse dosi di radioterapia. Lo studio, pubblicato anche negli Annals of Oncology, ha analizzato i dati di due studi di Fase 3, dimostrando che i pazienti con punteggi PORTOS più alti hanno tratto significativi benefici da dosi di radioterapia aumentate sia in contesti di radioterapia salvavita che definitiva.

Veracyte (VCYT) presentó nuevos datos en el Simposio ASCO 2025 sobre Cánceres Genitourinarios, demostrando la efectividad de sus pruebas Decipher para Próstata y Vejiga en la guía del tratamiento del cáncer. Los hallazgos clave de 17 resúmenes centrados en Decipher mostraron que el Clasificador Genómico para Próstata Decipher puede ayudar a identificar a los pacientes que se beneficiarán de la radioterapia en los ganglios pélvicos, mientras que la prueba Decipher para Vejiga identificó con precisión los casos de cáncer menos agresivos basados en subtipos moleculares.

Además, la investigación que utilizó la herramienta Decipher GRID de Veracyte validó la capacidad de la firma PORTOS para predecir la respuesta del paciente a diferentes dosis de radioterapia. El estudio, también publicado en Annals of Oncology, analizó datos de dos ensayos de Fase 3, mostrando que los pacientes con puntuaciones PORTOS más altas se beneficiaron significativamente de dosis de radiación aumentadas tanto en contextos de radioterapia salvadora como definitiva.

Veracyte (VCYT)는 2025 ASCO 비뇨기암 심포지엄에서 암 치료를 안내하는 데 있어 Decipher 전립선 및 방광 검사의 효과를 입증하는 새로운 데이터를 발표했습니다. Decipher에 초점을 맞춘 17개의 초록에서 주요 발견은 Decipher 전립선 유전체 분류기가 골반 림프절 방사선 치료의 혜택을 받을 환자를 식별하는 데 도움을 줄 수 있다는 점이었습니다. 한편, Decipher 방광 검사는 분자 아형을 기반으로 덜 공격적인 암 사례를 정확하게 식별했습니다.

또한, Veracyte의 Decipher GRID 도구를 이용한 연구는 PORTOS 서명이 다양한 방사선 치료 용량에 대한 환자의 반응을 예측할 수 있는 능력을 검증했습니다. 이 연구는 Annals of Oncology에 발표되었으며, 두 개의 3상 시험에서 데이터를 분석하여 PORTOS 점수가 높은 환자들이 구제 및 확정 방사선 치료 설정 모두에서 증가된 방사선 용량으로부터 상당한 혜택을 받았음을 보여주었습니다.

Veracyte (VCYT) a présenté de nouvelles données lors du Symposium ASCO 2025 sur les cancers génito-urinaires, démontrant l'efficacité de ses tests Decipher pour la prostate et la vessie dans l'orientation du traitement du cancer. Les résultats clés de 17 résumés axés sur Decipher ont montré que le Classificateur Génomique pour la Prostate Decipher peut aider à identifier les patients qui bénéficieront d'une radiothérapie des ganglions pelviens, tandis que le test Decipher pour la vessie a identifié avec précision les cas de cancer moins agressifs en fonction des sous-types moléculaires.

De plus, des recherches utilisant l'outil Decipher GRID de Veracyte ont validé la capacité de la signature PORTOS à prédire la réponse des patients à différentes doses de radiothérapie. L'étude, également publiée dans les Annals of Oncology, a analysé des données de deux essais de Phase 3, montrant que les patients ayant des scores PORTOS plus élevés ont considérablement bénéficié de doses de radiothérapie augmentées dans les contextes de radiothérapie salvatrice et définitive.

Veracyte (VCYT) hat auf dem ASCO 2025 Genitourinary Cancers Symposium neue Daten präsentiert, die die Wirksamkeit seiner Decipher Prostata- und Blasentests zur Unterstützung der Krebsbehandlung demonstrieren. Die wichtigsten Ergebnisse von 17 auf Decipher fokussierten Abstracts zeigten, dass der Decipher Prostata Genomic Classifier helfen kann, Patienten zu identifizieren, die von einer pelvinen Lymphknotenbestrahlung profitieren, während der Decipher Blasentest weniger aggressive Krebsfälle basierend auf molekularen Subtypen genau identifizierte.

Darüber hinaus validierte eine Forschung mit dem Decipher GRID-Tool von Veracyte die Fähigkeit der PORTOS-Signatur, die Patientenreaktion auf verschiedene Dosen der Strahlentherapie vorherzusagen. Die Studie, die ebenfalls in den Annals of Oncology veröffentlicht wurde, analysierte Daten aus zwei Phase-3-Studien und zeigte, dass Patienten mit höheren PORTOS-Werten signifikant von erhöhten Strahlendosen in sowohl salvager als auch definitiven Strahlentherapie-Einstellungen profitierten.

Positive
  • Decipher Prostate test successfully identified patients who would benefit from additional radiation therapy
  • Decipher Bladder test demonstrated accuracy in identifying less aggressive cancer cases
  • PORTOS signature validated in two Phase 3 trials for radiation therapy optimization
Negative
  • None.

Insights

The extensive validation of Veracyte's Decipher platform at ASCO GU 2025, supported by 17 abstracts and publication in Annals of Oncology, represents a significant strengthening of the company's market position in cancer diagnostics. The data demonstrates three important commercial advantages:

First, the Decipher Prostate test's ability to predict treatment response in the NRG Oncology/RTOG 0534 trial provides a clear clinical utility case for insurance coverage and physician adoption. This is particularly valuable as treatment intensification decisions directly impact patient outcomes and healthcare costs.

Second, the Decipher Bladder test's validation in identifying less aggressive cancer subtypes addresses a critical clinical need in bladder cancer staging. This could expand the test's market by providing actionable insights for treatment de-escalation, potentially reducing healthcare costs while improving patient care.

Third, the PORTOS signature's validation in two Phase 3 trials for radiation dose optimization represents a potential new revenue stream. While currently a research tool, its robust validation in predicting radiation therapy response could accelerate its path to clinical implementation, expanding Veracyte's diagnostic portfolio.

The breadth of evidence presented suggests strong potential for increased test adoption and possible expansion of insurance coverage. The validation across multiple independent trials and prestigious research institutions significantly enhances Veracyte's competitive moat in the precision oncology market, potentially accelerating market penetration and revenue growth.

Study showing that Decipher GRID-derived PORTOS signature predicts benefit from dose-escalated radiation therapy also published in Annals of Oncology

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that new data presented at the 2025 ASCO Genitourinary Cancers Symposium (ASCO GU) demonstrate the performance and clinical utility of its Decipher Prostate and Decipher Bladder tests to help guide treatment for patients with prostate and bladder cancer. Presented findings also show that the company’s Decipher GRID (Genomic Resource for Intelligent Discovery) research tool is enabling new data-based insights that in the future may help further advance personalized cancer care. The findings are from among 17 Decipher-focused abstracts being presented at the conference this week in San Francisco, as well as a new paper published in Annals of Oncology.

“The breadth and depth of Decipher-focused data presented at the ASCO GU Symposium reinforce the widespread impact our Decipher tests are having on clinical care, as well as on research into the molecular underpinnings of prostate and bladder cancers,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “They also demonstrate Veracyte’s commitment to clinical rigor and evidence development. We are grateful for our ongoing collaborations with leading clinician-researchers, which are enabling us to continue driving innovation that can further help patients.”

Key findings presented at the ASCO GU Symposium are:

Poster (Abstract #399): 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. Presented by Alan Pollack, M.D., Ph.D., University of Miami Health System.

This study found that the Decipher Prostate Genomic Classifier may inform treatment-intensification strategies for patients undergoing salvage radiotherapy by identifying those who will benefit from pelvic nodal radiation. The findings are from a post-hoc analysis of the NRG Oncology/RTOG 0534 (SPPORT) Phase 3, randomized trial. Decipher Prostate test results were obtained for 709 patients who experienced biochemical recurrence following prostatectomy and were allocated to three treatment study arms: 1.) prostate bed radiation therapy alone (PBRT); 2.) PBRT and short-term androgen deprivation therapy (STADT); or 3.) PBRT, STADT and pelvic lymph node radiation therapy (PLNRT). They found that patients with high Decipher Prostate scores received greater benefit from the addition of PLNRT and STADT to PBRT, compared to those with low genomic test scores.

“The addition of pelvic node radiotherapy to PBRT and short-term ADT is becoming more frequently used for patients with high-risk prostate cancer undergoing salvage radiation,” said Dr. Davicioni, an author on the study. “Accurately determining which patients are likely to benefit from this strategy, however, can be challenging but is especially important given its additional toxicity and potential side effects. Our findings show that Decipher Prostate test results can provide physicians with important information to help guide treatment decision-making with their patients.”

Poster (Abstract #831): A non-coding RNA based classifier for favorable outcomes in clinically organ confined bladder cancer. Presented by Yair Lotan, M.D., UT Southwestern Medical Center.

In this study, researchers demonstrated that the Decipher Bladder Genomic Subtyping Classifier accurately identified patients whose bladder cancer was less aggressive, based on their cancer’s molecular subtype. The study involved 226 patients with high-grade, clinically organ-confined bladder cancer who subsequently underwent radical cystectomy without any neoadjuvant therapy. The researchers found that patients with the luminal favorable bladder cancer subtype, compared to those without it, had significantly lower likelihood of being upstaged to T3+ disease (OR 0.32, 95% CI 0.12-0.82; P= 0.02) or to any upstaging (OR 0.41, 95% CI 0.20-0.83; P=0.01). They also found that the luminal favorable subtype was significantly associated with better overall survival (HR 0.33, 95% CI 0.15-0.74; P=0.007).

“Accurate clinical staging in bladder cancer can be challenging, limiting clinicians’ ability to guide treatment decisions for their patients,” said Dr. Lotan. “Our findings suggest that molecular subtyping information provided by the Decipher Bladder test can help physicians better identify which patients have less-aggressive bladder cancer and may not require treatment intensification.”

Oral Presentation (Abstract #308): Gene signature predictor of dose-response to prostate radiation: validation of PORTOS in phase III trials. Presented by Shuang Zhao, M.D., University of Wisconsin-Madison.

This study’s oral presentation at the ASCO GU Symposium also corresponded with its publication in Annals of Oncology. The findings demonstrate that PORTOS (Post-Operative Radiation Therapy Outcomes Score), a genomic signature developed using Veracyte’s Decipher GRID research tool, predicts which patients with prostate cancer are likely to benefit from differing dosages of salvage and definitive radiation therapy. The findings are from post-hoc analyses of the SAKK 09/10 and NRG Oncology/RTOG 0126 Phase 3, randomized clinical trials.

Among the 226 patients evaluated from the SAKK 09/10 trial, those with higher PORTOS scores were significantly more likely to benefit from dose-increased (70 Gy vs. 64 Gy) salvage radiotherapy, compared to those with lower PORTOS scores. Additionally, among 215 patients undergoing definitive radiotherapy in the NRG Oncology/RTOG 0126 trial, those with higher PORTOS scores were more likely to benefit from dose escalation (79.2 Gy vs. 70.2 Gy), compared to those with lower PORTOS scores. An analysis using the whole-transcriptome-based Decipher GRID research tool’s database showed that there were no strong associations between the PORTOS signature and clinicopathologic variables such as race, PSA levels, clinical stage, grade group or NCCN risk status.

“Physicians are currently limited in their tools for determining which patients with prostate cancer will benefit from dose-escalated radiation therapy. Our findings, derived from two Phase 3, randomized trials, suggest that the research-based PORTOS signature has potential to be a useful clinical tool to help inform important radiation treatment decisions for patients following a prostate cancer diagnosis or who are experiencing biochemical recurrence,” said Dr. Zhao, who also helped develop the PORTOS signature.

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 IB” 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 Subtyping 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 Prostate and Decipher Bladder tests to help guide treatment for patients with prostate and bladder cancer and Decipher GRID to enable new data-based insights that may in the future help further advance personalized cancer care; that the Decipher Prostate Genomic Classifier may inform treatment-intensification strategies for patients undergoing salvage radiotherapy by identifying those who will benefit from pelvic nodal radiation; that the findings suggest that the Decipher Bladder test can help physicians better identify which patients have less-aggressive bladder cancer and may not require treatment intensification; and that the PORTOS signature has potential to be a useful clinical tool to help inform important radiation treatment decisions for patients following a prostate cancer diagnosis or who are experiencing biochemical recurrence. Forward-looking statements can be identified by words such as: “appears,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “expect,” “believe,” “should,” “may,” “could,” “would,” “will,” “potentially,” “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 U.S. and selected countries.

* 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.

Investors:

Shayla Gorman

investors@veracyte.com

619-393-1545



Media:

Tracy Morris

media@veracyte.com

650-380-4413

Source: Veracyte, Inc.

FAQ

What were the key findings of VCYT's Decipher tests presented at ASCO GU 2025?

The studies showed that Decipher Prostate test can identify patients who benefit from pelvic nodal radiation, and Decipher Bladder test accurately identified less aggressive cancer cases through molecular subtyping.

How did the PORTOS signature perform in the Phase 3 trials for VCYT?

PORTOS signature successfully predicted which patients would benefit from increased radiation doses in both the SAKK 09/10 and NRG Oncology/RTOG 0126 Phase 3 trials.

What were the results of VCYT's Decipher Bladder test study?

The study of 226 patients showed that those with luminal favorable subtype had significantly lower likelihood of disease upstaging and better overall survival.

How many Decipher-focused abstracts did VCYT present at ASCO GU 2025?

Veracyte presented 17 Decipher-focused abstracts at the 2025 ASCO Genitourinary Cancers Symposium.

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