NCCN Prostate Cancer Guidelines Reinforce Status of Myriad Genetics' Prolaris® Test as an 'Advanced Tool' Recommended for Prognostic Assessment
Myriad Genetics announced that its Prolaris prostate cancer prognostic test maintains its status as an 'Advanced Tool' in the National Comprehensive Cancer Network (NCCN) guidelines for the 10th consecutive year. The test continues to be included with a category 2A level of evidence, indicating support from at least 85% of NCCN prostate panel members.
Prolaris is uniquely positioned as the only test developed in untreated patients and the only one with two clinically validated thresholds: an active surveillance threshold and a multimodal threshold. The company has published over 25 studies supporting Prolaris' value in clinical decision-making. Recent studies have validated the test's ability to predict early metastasis and treatment timing, as well as its accuracy in predicting benefits of combining androgen deprivation therapy with radiation therapy.
Myriad Genetics ha annunciato che il suo test prognostico per il cancro alla prostata Prolaris mantiene il suo status di 'Strumento Avanzato' nelle linee guida del National Comprehensive Cancer Network (NCCN) per il decimo anno consecutivo. Il test continua a essere incluso con un livello di evidenza di categoria 2A, che indica un supporto da parte di almeno l'85% dei membri del pannello prostatica dell'NCCN.
Prolaris si presenta come l'unico test sviluppato in pazienti non trattati e l'unico con due soglie clinicamente validate: una soglia per il monitoraggio attivo e una soglia multimodale. L'azienda ha pubblicato oltre 25 studi a sostegno del valore di Prolaris nella presa di decisioni cliniche. Studi recenti hanno convalidato la capacità del test di prevedere le metastasi precoci e il timing del trattamento, così come la sua accuratezza nel predire i benefici della combinazione della terapia di deprivazione androgenica con la radioterapia.
Myriad Genetics anunció que su prueba pronóstica para el cáncer de próstata Prolaris mantiene su estatus como 'Herramienta Avanzada' en las guías del National Comprehensive Cancer Network (NCCN) por décimo año consecutivo. La prueba sigue incluida con un nivel de evidencia de categoría 2A, lo que indica el apoyo de al menos el 85% de los miembros del panel de próstata de la NCCN.
Prolaris está posicionada de manera única como la única prueba desarrollada en pacientes no tratados y la única con dos umbrales clínicamente validados: un umbral para vigilancia activa y un umbral multimodal. La compañía ha publicado más de 25 estudios que apoyan el valor de Prolaris en la toma de decisiones clínicas. Estudios recientes han validado la capacidad de la prueba para predecir la metástasis temprana y el momento del tratamiento, así como su precisión al predecir los beneficios de combinar la terapia de privación androgénica con la radioterapia.
Myriad Genetics는 Prolaris 전립선암 예후 검사가 National Comprehensive Cancer Network (NCCN) 가이드라인에서 10년 연속으로 '고급 도구'로서의 지위를 유지한다고 발표했습니다. 이 검사는 NCCN 전립선 패널 구성원의 85% 이상이 지지하는 것을 나타내는 2A 카테고리 증거 수준으로 포함되어 있습니다.
Prolaris는 치료받지 않은 환자에서 개발된 유일한 검사로, 두 가지 임상적으로 검증된 기준을 가진 유일한 검사로 독특하게 자리 잡고 있습니다: 활성 감시 기준과 다중 모드 기준. 이 회사는 Prolaris의 임상적 의사 결정 가치를 뒷받침하는 25개 이상의 연구를 발표했습니다. 최근 연구는 조기 전이와 치료 시점을 예측하는 검사 능력과, 안드로겐 제거 요법과 방사선 요법을 결합한 혜택을 예측하는 정확성을 검증했습니다.
Myriad Genetics a annoncé que son test pronostique Prolaris pour le cancer de la prostate conserve son statut d' 'Outil Avancé' dans les directives du National Comprehensive Cancer Network (NCCN) pour la dixième année consécutive. Le test continue d'être inclus avec un niveau de preuve de catégorie 2A, indiquant le soutien d'au moins 85 % des membres du panel de prostate de la NCCN.
Prolaris se distingue comme le seul test développé chez des patients non traités et le seul avec deux seuils cliniquement validés : un seuil de surveillance active et un seuil multimodal. L'entreprise a publié plus de 25 études soutenant la valeur de Prolaris dans la prise de décision clinique. Des études récentes ont validé la capacité du test à prédire les métastases précoces et le moment du traitement, ainsi que son exactitude à prédire les bénéfices de la combinaison de la thérapie de déprivation androgénique avec la radiothérapie.
Myriad Genetics gab bekannt, dass sein Prolaris-Prostatakrebs-Prognosetest seinen Status als 'Fortgeschrittenes Werkzeug' in den Leitlinien des National Comprehensive Cancer Network (NCCN) im zehnten Jahr in Folge beibehält. Der Test bleibt mit einem Evidenzlevel der Kategorie 2A enthalten, was die Unterstützung von mindestens 85 % der Mitglieder des NCCN-Prostatapaneels anzeigt.
Prolaris ist einzigartig positioniert, da es der einzige Test ist, der bei unbehandelten Patienten entwickelt wurde, und der einzige mit zwei klinisch validierten Schwellenwerten: einem Schwellenwert für aktive Überwachung und einem multimodalen Schwellenwert. Das Unternehmen hat über 25 Studien veröffentlicht, die den Wert von Prolaris bei der klinischen Entscheidungsfindung unterstützen. Jüngste Studien haben die Fähigkeit des Tests validiert, frühe Metastasen und den Zeitpunkt der Behandlung vorherzusagen, sowie seine Genauigkeit bei der Vorhersage der Vorteile der Kombination von Androgenentzugstherapie mit Strahlentherapie.
- Prolaris maintains NCCN 'Advanced Tool' status for 10th consecutive year
- Strong clinical validation with over 25 published studies
- Unique position as only test with two clinically validated thresholds
- Recent studies validate test's ability to predict early metastasis and treatment benefits
- None.
Insights
The NCCN's continued recognition of Prolaris as an 'Advanced Tool' with Category 2A evidence level represents a solid validation of the test's clinical utility. The test's unique positioning with dual validated thresholds - for active surveillance and treatment intensification - provides significant clinical value in prostate cancer management.
The recent independent studies validating Prolaris' predictive capabilities for early metastasis and treatment timing are particularly noteworthy. The ability to predict ADT benefit when combined with radiation therapy adds another valuable dimension to treatment planning. However, while these developments are positive for Myriad's clinical positioning, the immediate financial impact may be moderate as the test was already well-established in clinical practice.
While the NCCN guideline retention is positive, it primarily maintains status quo rather than expanding market opportunity. The clarification regarding "mischaracterizations" suggests some market confusion that could have impacted sentiment. However, Myriad's strong publication record (25+ studies) and unique dual-threshold capabilities provide competitive differentiation in the prostate cancer diagnostics market.
The test's ability to guide both active surveillance and treatment intensification decisions positions it well in the value-based care environment. Yet, this news primarily reinforces existing market position rather than opening new revenue streams. The focus should be on monitoring whether this translates to sustained or expanded clinical adoption and reimbursement coverage.
Prolaris Remains a Long-Standing Fixture in the Guidelines for 10th Year Running
SALT LAKE CITY, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced that its Prolaris prostate cancer prognostic test continues to be classified by the National Comprehensive Cancer Network (NCCN®) as an ‘Advanced Tool’ in the fight against prostate cancer1. Like other gene expression-based tests, Prolaris for many years has been included in NCCN guidelines with category 2A level of evidence, meaning its inclusion has support from at least
“The updated NCCN Prostate Cancer Guidelines continue to solidify Prolaris' market position,” said Paul J. Diaz, President and CEO, Myriad Genetics. “While there have been certain mischaracterizations regarding the updated guidelines leading to confusion, extensive published evidence shows that Prolaris is a clinically recognized and effective tool in managing patients with prostate cancer. We are confident that our highly engaged clinicians will continue to see the guidelines as an additional reason to incorporate Prolaris in treatment decisions.”
“Prolaris is the Only test developed in untreated patients and the Only test with two clinically validated thresholds. With its active surveillance threshold, Prolaris identifies the most appropriate patients for active surveillance across all biomarkers,” said George Daneker, Jr. MD, President and Chief Clinical Officer, Oncology, Myriad Genetics. “With its multimodal threshold, Prolaris can identify which patients may consider treatment intensification3.”
Myriad has published more than 25 studies demonstrating the value of Prolaris in clinical decision-making for prostate cancer. This year alone, multiple studies have been published and presented as further evidence of the clinical utility of the Prolaris test. In an independent prospective study, investigators validated the Prolaris score's ability to predict both early metastasis within three years and a quicker time to definitive treatment for patients above the active surveillance threshold. Another study demonstrated that Prolaris can accurately predict the benefit of adding androgen deprivation therapy (ADT) to radiation therapy (RT) in men with localized prostate cancer.
About the Prolaris Prostate Cancer Prognostic Test
Prolaris is a molecular diagnostic test that provides personalized information about the aggressiveness of a patient’s prostate cancer, helping to identify whether it is safe to forgo treatment, whether to pursue treatment, and how much treatment is needed for the best possible outcome. Prolaris is the only biomarker test to quantify the benefits of adding androgen ADT to RT.
About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company’s Prolaris test and how with its active surveillance threshold, Prolaris identifies the most appropriate patients for active surveillance across all biomarkers, and that clinicians will continue to see the guidelines as an additional reason to incorporate Prolaris in treatment decisions. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.
1 “Advanced tools that have demonstrated superior prognostic performance beyond standard tools and/or serve as a predictive biomarker that identifies patients who will differentially benefit from a specific treatment.” Version 1.2025, 12/04/24 © 2024 National Comprehensive Cancer Network® (NCCN®)
2 https://www.nccn.org/guidelines/guidelines-process/development-and-update-of-guidelines
3 Tward JD, et al. Personalizing localized prostate cancer: Validation of a combined clinical cell-cycle risk (CCR) score threshold for prognosticating benefit from multimodality therapy. Clinical Genitourinary Cancer. 2021. Doi:10.1016/j.clgc.2021.01.003
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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