New Data Demonstrate Accuracy of Veracyte’s Whole-Genome Sequencing-Based MRD Testing Platform for Muscle-Invasive Bladder Cancer
Veracyte (VCYT) announced new data demonstrating superior accuracy of its whole-genome sequencing (WGS)-based minimal residual disease (MRD) testing platform for muscle-invasive bladder cancer. The findings from the TOMBOLA trial, involving 100 patients, showed the platform detected cancer recurrence with higher specificity (88%) compared to ddPCR (62%), while maintaining equivalent negative predictive value (~96%).
The study revealed that Veracyte's MRD testing platform detected cancer recurrence 93 days earlier than standard imaging. The platform combines WGS and artificial intelligence to detect residual cancer in blood samples, requiring less blood and delivering faster results compared to traditional methods.
The company plans to launch its first MRD test for muscle-invasive bladder cancer in the first half of 2026. The platform establishes patient-specific genomic signatures by analyzing cancer mutations in tumor tissue and blood samples, enabling ongoing monitoring of tumor progression throughout treatment and follow-up care.
Veracyte (VCYT) ha annunciato nuovi dati che dimostrano la superiorità della sua piattaforma di test per la malattia residua minima (MRD) basata sul sequenziamento dell'intero genoma (WGS) per il cancro della vescica invasivo muscolare. I risultati del trial TOMBOLA, che ha coinvolto 100 pazienti, hanno mostrato che la piattaforma ha rilevato la recidiva del cancro con una specificità maggiore (88%) rispetto al ddPCR (62%), mantenendo un valore predittivo negativo equivalente (~96%).
Lo studio ha rivelato che la piattaforma di test MRD di Veracyte ha rilevato la recidiva del cancro 93 giorni prima rispetto all'imaging standard. La piattaforma combina WGS e intelligenza artificiale per rilevare il cancro residuo nei campioni di sangue, richiedendo meno sangue e fornendo risultati più rapidi rispetto ai metodi tradizionali.
L'azienda prevede di lanciare il suo primo test MRD per il cancro della vescica invasivo muscolare nella prima metà del 2026. La piattaforma stabilisce firme genomiche specifiche per il paziente analizzando le mutazioni tumorali nei tessuti tumorali e nei campioni di sangue, consentendo un monitoraggio continuo della progressione del tumore durante il trattamento e la cura di follow-up.
Veracyte (VCYT) anunció nuevos datos que demuestran la superioridad de su plataforma de pruebas de enfermedad residual mínima (MRD) basada en secuenciación del genoma completo (WGS) para el cáncer de vejiga muscular invasivo. Los hallazgos del ensayo TOMBOLA, que involucró a 100 pacientes, mostraron que la plataforma detectó la recurrencia del cáncer con una especificidad mayor (88%) en comparación con ddPCR (62%), manteniendo un valor predictivo negativo equivalente (~96%).
El estudio reveló que la plataforma de pruebas MRD de Veracyte detectó la recurrencia del cáncer 93 días antes que la imagenología estándar. La plataforma combina WGS e inteligencia artificial para detectar cáncer residual en muestras de sangre, requiriendo menos sangre y ofreciendo resultados más rápidos en comparación con los métodos tradicionales.
La empresa planea lanzar su primera prueba MRD para el cáncer de vejiga muscular invasivo en la primera mitad de 2026. La plataforma establece firmas genómicas específicas para el paciente al analizar las mutaciones cancerosas en el tejido tumoral y en las muestras de sangre, lo que permite un monitoreo continuo de la progresión del tumor durante el tratamiento y el seguimiento.
Veracyte (VCYT)는 근육 침습성 방광암에 대한 전체 유전자 서열 분석(WGS) 기반의 최소 잔여 질병(MRD) 검사 플랫폼의 우수한 정확성을 입증하는 새로운 데이터를 발표했습니다. 100명의 환자가 참여한 TOMBOLA 시험의 결과에 따르면, 이 플랫폼은 ddPCR(62%)에 비해 암 재발을 더 높은 특이성(88%)으로 감지했으며, 동등한 음성 예측 가치를 유지했습니다(~96%).
이 연구는 Veracyte의 MRD 검사 플랫폼이 표준 이미징보다 93일 더 일찍 암 재발을 감지했다고 밝혔습니다. 이 플랫폼은 WGS와 인공지능을 결합하여 혈액 샘플에서 잔여 암을 감지하며, 전통적인 방법에 비해 적은 양의 혈액을 필요로 하고 더 빠른 결과를 제공합니다.
회사는 2026년 상반기에 근육 침습성 방광암에 대한 첫 MRD 검사를 출시할 계획입니다. 이 플랫폼은 종양 조직과 혈액 샘플에서 암 변이를 분석하여 환자별 유전체 서명을 설정하여 치료 및 추적 관찰 중 종양 진행 상황을 지속적으로 모니터링할 수 있도록 합니다.
Veracyte (VCYT) a annoncé de nouvelles données démontrant la précision supérieure de sa plateforme de tests de maladie résiduelle minimale (MRD) basée sur le séquençage de l'ensemble du génome (WGS) pour le cancer de la vessie invasif musculaire. Les résultats de l'essai TOMBOLA, impliquant 100 patients, ont montré que la plateforme détectait la récidive du cancer avec une spécificité plus élevée (88%) par rapport au ddPCR (62%), tout en maintenant une valeur prédictive négative équivalente (~96%).
L'étude a révélé que la plateforme de tests MRD de Veracyte détectait la récidive du cancer 93 jours plus tôt que l'imagerie standard. La plateforme combine WGS et intelligence artificielle pour détecter le cancer résiduel dans des échantillons de sang, nécessitant moins de sang et fournissant des résultats plus rapides par rapport aux méthodes traditionnelles.
L'entreprise prévoit de lancer son premier test MRD pour le cancer de la vessie invasif musculaire dans la première moitié de 2026. La plateforme établit des signatures génomiques spécifiques au patient en analysant les mutations cancéreuses dans les tissus tumoraux et les échantillons de sang, permettant un suivi continu de la progression tumorale tout au long du traitement et des soins de suivi.
Veracyte (VCYT) hat neue Daten veröffentlicht, die die überlegene Genauigkeit seiner auf der Ganzgenomsequenzierung (WGS) basierenden Plattform für Tests auf minimale Resterkrankung (MRD) bei muskelinvasivem Blasenkarzinom belegen. Die Ergebnisse der TOMBOLA-Studie, an der 100 Patienten beteiligt waren, zeigten, dass die Plattform Krebsrezidive mit höherer Spezifität (88%) im Vergleich zu ddPCR (62%) nachweisen konnte, während ein äquivalenter negativer prädiktiver Wert (~96%) beibehalten wurde.
Die Studie ergab, dass die MRD-Testplattform von Veracyte Krebsrezidive 93 Tage früher als die Standardbildgebung nachweisen konnte. Die Plattform kombiniert WGS und künstliche Intelligenz, um Resterkrankungen in Blutproben zu erkennen, benötigt weniger Blut und liefert schnellere Ergebnisse im Vergleich zu herkömmlichen Methoden.
Das Unternehmen plant, in der ersten Hälfte von 2026 seinen ersten MRD-Test für muskelinvasives Blasenkarzinom auf den Markt zu bringen. Die Plattform erstellt patientenspezifische genomische Signaturen, indem sie Krebsmutationen in Tumorgewebe und Blutproben analysiert, was eine kontinuierliche Überwachung des Tumorverlaufs während der Behandlung und Nachsorge ermöglicht.
- Higher specificity (88%) compared to current ddPCR testing (62%)
- Earlier detection of cancer recurrence by 93 days compared to imaging
- Platform requires less blood and delivers faster results than traditional methods
- Product launch not until first half of 2026
- Longer follow-up still required to determine clinical impact
Insights
Veracyte's whole-genome sequencing (WGS)-based minimal residual disease (MRD) testing platform demonstrates significant clinical advantages over existing methods. The TOMBOLA trial data reveals an equivalent negative predictive value (95.9% vs 96.2%) but higher specificity (88% vs 62%) compared to ddPCR, suggesting fewer false positives. The platform also detected cancer recurrence a median of 93 days earlier than imaging—a critical timeframe that could fundamentally alter treatment pathways.
This technological approach solves key limitations in current MRD testing. By integrating whole-genome sequencing with AI to establish patient-specific genomic signatures, Veracyte's platform reduces blood volume requirements and accelerates results delivery. For muscle-invasive bladder cancer patients, where recurrence rates reach 50% within two years, this early detection capability offers clinicians a substantial advantage in treatment planning.
The technology's ability to characterize the complete set of cancer mutations creates a comprehensive profile that can be tracked throughout treatment. This represents a paradigm shift from targeted approaches that might miss critical mutations. While longer follow-up is needed to confirm clinical impact, these results suggest Veracyte is positioned to deliver meaningful improvements in post-treatment surveillance for bladder cancer patients when this test launches in 2026.
Veracyte's advancement in MRD testing represents a strategic expansion of their diagnostic portfolio and opens a new revenue stream beyond their established Decipher tests. The TOMBOLA trial results validate their technical approach, potentially positioning the company advantageously in the growing liquid biopsy market. The 93-day earlier detection capability creates a compelling value proposition that could drive clinician adoption and favorable reimbursement decisions.
The planned 2026 launch timeline means revenue impact is not immediate, but it establishes a clear growth vector beyond their current offerings. By leveraging their existing presence in urologic cancers, Veracyte can capitalize on established clinician relationships—the seven abstracts on their Decipher tests at the same conference demonstrate their urologic cancer testing footprint.
Veracyte's platform advantages in requiring less blood and providing faster results address common limitations in the emerging MRD testing space. While competition in liquid biopsy is intensifying, proprietary whole-genome sequencing combined with AI creates differentiation in a crowded market. The bladder cancer indication represents a focused initial approach with the potential to expand into additional cancer types, as mentioned in their pipeline. This technology validation enhances Veracyte's competitive positioning in precision oncology diagnostics and supports their long-term diversification strategy beyond tissue-based testing.
Findings from TOMBOLA Trial Were Presented at EAU25
The new study involved 100 patients enrolled in the TOMBOLA trial who had MIBC and were undergoing standard-of-care neoadjuvant chemotherapy (NAC) and radical cystectomy (RC). Their blood samples were evaluated for circulating tumor DNA (ctDNA) using both ddPCR-based and Veracyte’s WGS-based MRD testing platform to detect disease recurrence. Patients also underwent imaging. At the 6-month milestone, in comparison to ddPCR, the Veracyte MRD testing platform had an equivalent and outstanding negative predictive value (
“Up to half of patients with muscle-invasive bladder cancer experience recurrence within two years of initial treatment, and using ctDNA status to guide oncological treatment would spare some patients from unnecessary treatments,” said Lars Dyrskjøt Andersen, Ph.D., professor in the Department of Clinical Medicine and Department of Molecular Medicine at
Veracyte’s MRD testing platform utilizes a combination of whole-genome sequencing and artificial intelligence (AI) to provide fast and accurate detection of residual cancer in a patient’s blood sample. This approach requires less blood and offers faster results, compared to ctDNA testing that uses bespoke panels, enabling earlier detection and improved outcomes. Veracyte’s MRD testing platform characterizes the complete set of cancer mutations in the tumor tissue sample and blood to establish a patient-specific, landmark genomic signature. It then uses whole-genome sequencing and AI to detect that signature in subsequent blood samples, indicating that cancer is present, and to track tumor progression throughout the patient’s treatment and follow-up care. Veracyte plans to launch its first MRD test in muscle-invasive bladder cancer in the first half of 2026, with other cancer indications to follow.
“The new data presented at EAU25 reinforce the power of the Veracyte Diagnostics Platform, which is at the core of all of our tests and will now enable us to expand into MRD testing in a clinically meaningful way,” said Philip Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer. “With our first MRD test in muscle-invasive bladder cancer, we are excited to expand our test offerings along the care continuum in urologic cancers where our Decipher tests are widely used and trusted by clinicians to help guide prognosis and treatment decisions.”
In addition to the new data for Veracyte’s MRD testing platform, seven abstracts focused on the company’s Decipher Prostate and Decipher Bladder tests were presented at EAU25. More information can be found at the EAU25 website.
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's performance and clinical utility has been demonstrated in over 85 studies involving more than 200,000 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 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 power of Veracyte’s whole-genome approach, which will now enable us to expand into MRD testing in a clinically meaningful way; our plans to launch our first MRD test in muscle-invasive bladder cancer in the first half of 2026, with other cancer indications to follow; and that Veracyte’s whole-genome sequencing approach to MRD testing may improve overall clinical utility, compared to ddPCR. 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 28, 2025. 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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Source: Veracyte, Inc.
FAQ
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