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Veracyte’s Decipher Prostate Test Is Now the Only Gene Expression Test Recommended in NCCN® Prostate Cancer Guidelines

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Veracyte's Decipher Prostate Genomic Classifier has achieved a significant milestone as the only gene expression test included in the 2025 NCCN Clinical Practice Guidelines for prostate cancer. The test, which uses a 22-gene signature to assess the likelihood of prostate tumor metastasis, helps clinicians make informed treatment decisions.

The test's inclusion in the guidelines is backed by extensive validation through numerous peer-reviewed studies and analyses from multiple Phase 3 clinical trials. As the most widely used molecular test in prostate cancer, this recognition in the NCCN guidelines is expected to increase its accessibility to more patients.

Il Decipher Prostate Genomic Classifier di Veracyte ha raggiunto un traguardo significativo, essendo l'unico test di espressione genica incluso nelle Linee Guida Cliniche NCCN per il cancro alla prostata del 2025. Questo test, che utilizza una firma genica di 22 geni per valutare la probabilità di metastasi del tumore prostatico, aiuta i medici a prendere decisioni di trattamento informate.

L'inclusione di questo test nelle linee guida è supportata da una vasta validazione tramite numerosi studi revisionati da esperti e analisi di vari studi clinici di Fase 3. Essendo il test molecolare più ampiamente utilizzato nel cancro alla prostata, questo riconoscimento nelle linee guida NCCN dovrebbe aumentarne l'accessibilità a un numero maggiore di pazienti.

El Decipher Prostate Genomic Classifier de Veracyte ha alcanzado un hito significativo al ser el único test de expresión génica incluido en las Guías de Práctica Clínica NCCN para el cáncer de próstata de 2025. Esta prueba, que utiliza una firma genética de 22 genes para evaluar la probabilidad de metástasis en tumores prostáticos, ayuda a los clínicos a tomar decisiones de tratamiento informadas.

La inclusión de esta prueba en las guías cuenta con un amplio respaldo a través de numerosas investigaciones revisadas por pares y análisis de múltiples ensayos clínicos de Fase 3. Siendo la prueba molecular más utilizada en el cáncer de próstata, se espera que este reconocimiento en las guías NCCN aumente su accesibilidad a más pacientes.

VeracyteDecipher Prostate Genomic Classifier는 2025 NCCN 전립선암 임상 진료 지침에 포함된 유일한 유전자 표현 테스트로서 중요한 이정표를 세웠습니다. 이 테스트는 22개 유전자 서명을 사용하여 전립선 종양의 전이 가능성을 평가하며, 임상의들이 정보에 기반한 치료 결정을 내리는 데 도움을 줍니다.

이 테스트의 지침 포함은 여러 개의 동료 검토 연구 및 다수의 3상 임상 시험 분석을 통해 광범위한 검증으로 뒷받침됩니다. 전립선암에서 가장 널리 사용되는 분자 테스트로서, NCCN 지침에서의 이 인식은 더 많은 환자에게 접근할 수 있게 할 것으로 기대됩니다.

Le Decipher Prostate Genomic Classifier de Veracyte a atteint une étape importante en tant que test d'expression génique unique inclus dans les Directives de Pratique Clinique NCCN pour le cancer de la prostate de 2025. Ce test, qui utilise une signature de 22 gènes pour évaluer la probabilité de métastases des tumeurs prostatiques, aide les cliniciens à prendre des décisions de traitement éclairées.

L'inclusion du test dans les directives est soutenue par une validation approfondie à travers de nombreuses études évaluées par des pairs et des analyses provenant de multiples essais cliniques de Phase 3. En tant que test moléculaire le plus largement utilisé dans le cancer de la prostate, cette reconnaissance dans les directives NCCN devrait accroître son accessibilité à un plus grand nombre de patients.

Der Decipher Prostate Genomic Classifier von Veracyte hat einen bedeutenden Meilenstein erreicht, da er der einzige Gentest ist, der in die klinischen Praxisrichtlinien der NCCN für Prostatakrebs 2025 aufgenommen wurde. Der Test, der ein 22-Gen-Signatur verwendet, um die Wahrscheinlichkeit einer Prostatatumormetastasierung zu bewerten, hilft Klinikern, informierte Behandlungsentscheidungen zu treffen.

Die Aufnahme des Tests in die Richtlinien wird durch umfangreiche Validierungen aus zahlreichen begutachteten Studien und Analysen mehrerer Phase-3-Studien untermauert. Als der am häufigsten verwendete molekulare Test bei Prostatakrebs wird erwartet, dass diese Anerkennung in den NCCN-Richtlinien die Zugänglichkeit für mehr Patienten erhöhen wird.

Positive
  • Decipher Prostate test becomes the only gene expression test recommended in NCCN Guidelines
  • Test is already the most widely used molecular test in prostate cancer
  • Recognition in NCCN guidelines expected to increase market accessibility
  • Extensive validation through multiple Phase 3 clinical trials
Negative
  • None.

Insights

The NCCN Guidelines' exclusive recommendation of Decipher Prostate as the only gene expression test represents a significant competitive advantage for Veracyte in the prostate cancer diagnostics market. The test's inclusion is backed by extensive clinical validation through multiple Phase 3 trials and peer-reviewed studies, demonstrating superior scientific credibility. This 22-gene signature test helps stratify patient risk for metastatic disease, directly impacting treatment decisions. The exclusive recommendation will likely drive increased adoption among clinicians, potentially expanding Veracyte's market share and revenue streams. Medicare and private insurers often align coverage policies with NCCN guidelines, which could improve reimbursement prospects and market access.

This NCCN guideline update significantly strengthens Veracyte's market position in the $3.4B prostate cancer diagnostics sector. Being the sole recommended gene expression test creates a substantial barrier to entry for competitors and should accelerate market penetration. The Decipher test's unique status will likely influence physician adoption patterns and payer decisions, potentially driving revenue growth. This development could particularly impact competitors offering similar molecular testing solutions, effectively positioning Veracyte as the standard of care in prostate cancer risk assessment. The company's strategic focus on clinical validation and research collaborations has created a defendable market advantage.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its market-leading Decipher Prostate Genomic Classifier is the only gene expression test to be included in version 1 of the 2025 NCCN* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as part of the updated “Advanced Tools” table located in the Principles of Risk Stratification and Biomarkers section (PROS-H) .

“The Decipher Prostate test’s performance and clinical utility have been demonstrated in many dozens of peer-reviewed, published studies, including analyses of samples from multiple prospective, Phase 3 clinical trials, making it the most validated test of its kind for prostate cancer,” said Phil Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer. “We believe the Decipher Prostate test’s unique status in the NCCN guidelines stems from the evidence generated through our commitment to research and our numerous collaborations with leading prostate cancer researchers around the world.”

The Decipher Prostate test is a whole-transcriptome-derived, 22-gene signature that clinicians use to help assess the likelihood of a prostate tumor progressing to metastatic disease. Armed with this information, the clinician may recommend less-intensive or earlier, more-intensive treatment for the patient.

“The Decipher Prostate test is already the most widely used molecular test in prostate cancer. We believe its unique status in the updated NCCN guidelines will help make it more accessible to even more patients,” said Marc Stapley, Veracyte’s chief executive officer. “This milestone also further reinforces the power of our Veracyte Diagnostics Platform. This novel, data-driven approach enables us to continuously develop high-performing, well-validated tests like Decipher Prostate that are transforming care for patients facing cancer.”

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 and is the only gene expression test to be included 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 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 our belief that the Decipher Prostate test’s unique status in the NCCN guidelines stems from the evidence generated through our commitment to research and our numerous collaborations with leading prostate cancer researchers around the world. 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 Decipher Prostate test can have on scientific advancements in prostate cancer and, in turn, patients. 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 is unique about Veracyte's (VCYT) Decipher Prostate test in the 2025 NCCN Guidelines?

It is the only gene expression test included in the 2025 NCCN Guidelines for prostate cancer, specifically in the Advanced Tools table of the Risk Stratification and Biomarkers section.

How does Veracyte's (VCYT) Decipher Prostate test work?

It is a whole-transcriptome-derived, 22-gene signature test that helps assess the likelihood of a prostate tumor progressing to metastatic disease, enabling clinicians to make informed treatment decisions.

What clinical validation supports Veracyte's (VCYT) Decipher Prostate test?

The test has been validated through dozens of peer-reviewed, published studies, including analyses of samples from multiple prospective, Phase 3 clinical trials.

Veracyte, Inc.

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