Myriad Genetics Highlights MRD Clinical Validity Data at American Association for Cancer Research Annual Meeting
Myriad Genetics (NASDAQ: MYGN) announced new clinical data for their Precise™ MRD test in oligometastatic clear-cell renal cell carcinoma (ccRCC) patients at the AACR Annual Meeting. The study, presented by Dr. Chad Tang from MD Anderson Cancer Center, demonstrated that metastasis-directed radiation therapy helped patients delay or avoid systematic treatments while maintaining high survival rates of 94% at two years and 87% at three years.
The research showed that patients testing positive on Precise MRD initiated systemic therapy within a median of 27 months, while MRD-negative patients maintained on radiation therapy for 54 months. The test identified over 50% of patients as MRD-positive at baseline, demonstrating superior detection capabilities in ccRCC's challenging low tumor fractions compared to first-generation tests.
Additional research presented includes optimization of tumor-informed MRD panels and the benefits of including INDEL mutations for improved detection sensitivity. Precise MRD is currently available for research studies in partnership with academic and pharmaceutical investigators.
Myriad Genetics (NASDAQ: MYGN) ha annunciato nuovi dati clinici sul loro test Precise™ MRD nei pazienti con carcinoma renale a cellule chiare oligometastatico (ccRCC) durante l'AACR Annual Meeting. Lo studio, presentato dal dott. Chad Tang del MD Anderson Cancer Center, ha dimostrato che la radioterapia mirata alle metastasi ha aiutato i pazienti a ritardare o evitare trattamenti sistemici, mantenendo al contempo alti tassi di sopravvivenza del 94% a due anni e dell’87% a tre anni.
La ricerca ha evidenziato che i pazienti risultati positivi al test Precise MRD hanno iniziato la terapia sistemica dopo una mediana di 27 mesi, mentre i pazienti MRD-negativi sono stati trattati con radioterapia per 54 mesi. Il test ha identificato oltre il 50% dei pazienti come MRD-positivi alla diagnosi, dimostrando capacità di rilevamento superiori nelle difficili frazioni tumorali basse del ccRCC rispetto ai test di prima generazione.
Ulteriori ricerche presentate includono l’ottimizzazione dei pannelli MRD tumorali e i vantaggi dell’inclusione delle mutazioni INDEL per migliorare la sensibilità di rilevamento. Precise MRD è attualmente disponibile per studi di ricerca in collaborazione con istituzioni accademiche e aziende farmaceutiche.
Myriad Genetics (NASDAQ: MYGN) anunció nuevos datos clínicos sobre su prueba Precise™ MRD en pacientes con carcinoma de células claras renal oligometastásico (ccRCC) en la Reunión Anual de AACR. El estudio, presentado por el Dr. Chad Tang del MD Anderson Cancer Center, demostró que la radioterapia dirigida a las metástasis ayudó a los pacientes a retrasar o evitar tratamientos sistémicos, manteniendo altas tasas de supervivencia del 94% a los dos años y del 87% a los tres años.
La investigación mostró que los pacientes con resultado positivo en Precise MRD iniciaron terapia sistémica en una mediana de 27 meses, mientras que los pacientes MRD-negativos permanecieron con radioterapia durante 54 meses. La prueba identificó a más del 50% de los pacientes como MRD-positivos al inicio, demostrando capacidades de detección superiores en las difíciles fracciones tumorales bajas del ccRCC en comparación con las pruebas de primera generación.
Otras investigaciones presentadas incluyen la optimización de paneles MRD informados por tumor y los beneficios de incluir mutaciones INDEL para mejorar la sensibilidad de detección. Precise MRD está actualmente disponible para estudios de investigación en colaboración con investigadores académicos y farmacéuticos.
Myriad Genetics (NASDAQ: MYGN)는 AACR 연례 회의에서 희소전이성 투명세포 신세포암(ccRCC) 환자를 대상으로 한 Precise™ MRD 검사에 대한 새로운 임상 데이터를 발표했습니다. MD Anderson Cancer Center의 Chad Tang 박사가 발표한 이 연구는 전이 부위 방사선 치료가 환자들이 전신 치료를 지연하거나 피하는 데 도움을 주었으며, 2년 생존율 94%, 3년 생존율 87%의 높은 생존율을 유지함을 보여주었습니다.
연구 결과, Precise MRD 검사에서 양성 판정을 받은 환자들은 중앙값 27개월 내에 전신 치료를 시작한 반면, MRD 음성 환자들은 54개월 동안 방사선 치료를 유지했습니다. 이 검사는 ccRCC의 낮은 종양 분획에서 1세대 검사에 비해 우수한 검출 능력을 보여주며, 환자의 50% 이상을 MRD 양성으로 식별했습니다.
추가로 발표된 연구에는 종양 정보 기반 MRD 패널 최적화와 검출 민감도 향상을 위한 INDEL 돌연변이 포함의 이점이 포함됩니다. Precise MRD는 현재 학계 및 제약 연구자들과의 협력을 통해 연구용으로 제공되고 있습니다.
Myriad Genetics (NASDAQ : MYGN) a annoncé de nouvelles données cliniques concernant leur test Precise™ MRD chez des patients atteints de carcinome rénal à cellules claires oligométastatique (ccRCC) lors de la réunion annuelle de l’AACR. L’étude, présentée par le Dr Chad Tang du MD Anderson Cancer Center, a démontré que la radiothérapie dirigée vers les métastases aidait les patients à retarder ou éviter les traitements systémiques tout en maintenant des taux de survie élevés de 94 % à deux ans et 87 % à trois ans.
La recherche a montré que les patients positifs au test Precise MRD ont commencé une thérapie systémique après une médiane de 27 mois, tandis que les patients MRD-négatifs ont été maintenus sous radiothérapie pendant 54 mois. Le test a identifié plus de 50 % des patients comme MRD-positifs au départ, démontrant des capacités de détection supérieures dans les faibles fractions tumorales difficiles du ccRCC par rapport aux tests de première génération.
Des recherches supplémentaires présentées incluent l’optimisation des panels MRD informés par la tumeur et les avantages d’inclure les mutations INDEL pour améliorer la sensibilité de détection. Precise MRD est actuellement disponible pour des études de recherche en partenariat avec des chercheurs académiques et pharmaceutiques.
Myriad Genetics (NASDAQ: MYGN) hat neue klinische Daten zu ihrem Precise™ MRD-Test bei Patienten mit oligometastasiertem klarzelligem Nierenzellkarzinom (ccRCC) auf dem AACR-Jahrestreffen vorgestellt. Die Studie, präsentiert von Dr. Chad Tang vom MD Anderson Cancer Center, zeigte, dass metastasengerichtete Strahlentherapie den Patienten half, systemische Behandlungen zu verzögern oder zu vermeiden, während sie hohe Überlebensraten von 94 % nach zwei Jahren und 87 % nach drei Jahren aufrechterhielten.
Die Forschung ergab, dass Patienten, die im Precise MRD-Test positiv waren, innerhalb einer Medianzeit von 27 Monaten eine systemische Therapie begannen, während MRD-negative Patienten 54 Monate lang mit Strahlentherapie behandelt wurden. Der Test identifizierte über 50 % der Patienten bereits zu Beginn als MRD-positiv und zeigte damit eine überlegene Erkennungsfähigkeit bei den schwierigen niedrigen Tumorfraktionen des ccRCC im Vergleich zu Tests der ersten Generation.
Weitere vorgestellte Forschungen umfassen die Optimierung tumorinformierter MRD-Panels und die Vorteile der Einbeziehung von INDEL-Mutationen zur Verbesserung der Nachweisempfindlichkeit. Precise MRD ist derzeit für Forschungsstudien in Zusammenarbeit mit akademischen und pharmazeutischen Partnern verfügbar.
- High survival rates demonstrated: 94% at 2 years, 87% at 3 years
- Superior detection capability with >50% MRD-positive identification at baseline
- Test enables longer treatment monitoring periods (54 months for MRD-negative patients)
- Enhanced sensitivity for detecting low ctDNA levels compared to first-generation tests
- Test currently to research studies only, not yet commercially available
Insights
Myriad's MRD test shows promising clinical validity in challenging kidney cancer, potentially enabling less aggressive treatment approaches.
Myriad Genetics has presented significant clinical validation data for their Precise MRD (Minimal Residual Disease) test in patients with oligometastatic clear-cell renal cell carcinoma (ccRCC). This represents a notable technical achievement as ccRCC presents unique challenges for ctDNA detection - these tumors are heterogeneous, slow-growing, shed minimal DNA, and have trackable mutations.
The test demonstrated impressive sensitivity by detecting MRD in more than 50% of patients at baseline visits, despite the very low tumor fractions common in ccRCC. This is particularly meaningful because patients who tested MRD-negative were able to delay systemic therapy for a median of 54 months, compared to only 27 months for MRD-positive patients.
The study reported strong survival outcomes with this approach -
The technical innovations presented in the additional posters - optimized selection of tumor-informed MRD panels and inclusion of insertion/deletion mutations - represent meaningful improvements that enhance the test's sensitivity for detecting circulating tumor DNA.
It's important to note that Precise MRD is currently available only for research studies conducted jointly by Myriad and academic or pharmaceutical investigators. This clinical validation study represents a necessary step in the development process, though additional studies will likely be needed before clinical implementation.
Myriad's MRD test shows clinical validity in challenging cancer type, potentially expanding their diagnostic portfolio in oncology.
The clinical data for Myriad Genetics' Precise MRD test presented at AACR demonstrates meaningful progress in the company's oncology diagnostic portfolio. The selection for a podium presentation - rather than just a poster display - at a major scientific conference like AACR indicates recognition of the data's significance within the scientific community.
The test's performance in a challenging cancer type like ccRCC is noteworthy. By detecting MRD in more than 50% of baseline samples despite the low tumor fractions common in this cancer, Myriad's technology demonstrates sensitivity that could differentiate it in the MRD testing space.
Most significantly, the test demonstrated clinical utility by stratifying patients into groups with substantially different outcomes. MRD-negative patients maintained on targeted radiation therapy for a median of 54 months before requiring systemic therapy, compared to just 27 months for MRD-positive patients. This clear difference in outcomes establishes a clinical use case for the technology.
The company is continuing development with the test currently available only for research studies pursued jointly with academic or pharmaceutical partners. This indicates ongoing investment in the platform, with several "high-impact studies" mentioned as currently underway.
The two additional poster presentations on technical aspects of the platform - optimized panel selection and inclusion of insertion/deletion mutations - suggest Myriad continues to refine and improve the technology. These technical innovations appear focused on enhancing sensitivity, which is critical for MRD detection applications.
Podium presentation showcases the clinical application of Precise™ MRD
SALT LAKE CITY, April 25, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, announced new clinical data will be shared at the American Association for Cancer Research (AACR) Annual Meeting that highlights the performance of the Precise MRD test in patients with oligometastatic clear-cell renal cell carcinoma (ccRCC).
A podium presentation titled “Phase 2 trial of metastasis directed radiotherapy without systemic therapy (MRWS) for oligometastatic clear cell renal cell carcinoma (ccRCC) and investigation of circulating tumor DNA (ctDNA) as a personalized biomarker” will be presented by Dr. Chad Tang, M.D., associate professor in the department of genitourinary radiation oncology at The University of Texas MD Anderson Cancer Center (MDACC) on April 28. The abstract presentation number is CT132.
MRWS offers substantial advantages for patients compared to more aggressive frontline systemic therapies; however, no clinically-utilized prognostic markers exist to identify patients who would benefit from such treatment de-escalation strategies1. Moreover, oligometastatic ccRCC poses a unique challenge for MRD assays because tumors tend to be heterogeneous, slow growing, low shedding, and generally limited in trackable mutations1. Myriad’s ultrasensitive ctDNA MRD assay can detect very low ctDNA levels by employing large, tumor-informed panels and offers new possibilities for patients who might be optimal candidates for MRWS in lieu of systemic therapy, potentially avoiding serious side effects and high costs.
“This study demonstrated that metastasis-directed radiation therapy (MDT) can help patients delay or avoid systematic treatments without sacrificing outcomes. Overall survival was not compromised, with survival rates of
“We are delighted that this clinical readout of Precise MRD was selected as a late-breaking oral presentation at AACR,” said Dale Muzzey, chief scientific officer, Myriad Genetics. “In this study, our ultrasensitive MRD assay identified more than
In addition to the podium presentation by Dr. Tang, two Precise MRD posters will be on display on April 30 from 9:00am – 12:00pm in Section 10:
- Poster #6639: Optimized selection of tumor-informed MRD panels enhances sensitivity of ctDNA detection
Summary: Myriad’s Precise MRD test is an ultrasensitive second-generation hybrid-capture-based tumor-informed assay that detects ctDNA in the plasma and uses a novel ranking algorithm to select up to 1,000 high-confidence targets based on tumor-specific and target-specific features to optimize panel design for residual disease detection. - Poster #6641: Inclusion of INDEL somatic variants in MRD panels improves confidence in ctDNA residual release detection
Summary: Including insertion/deletion (INDEL) mutations in the tumor-informed, patient-specific tumor panels used to monitor for MRD in patients with cancer increases the likelihood of detecting low abundance ctDNA and achieving high sensitivity at low tumor concentrations.
Precise MRD is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators. Myriad continues to develop its Precise MRD assay to meet the needs of patients with cancer, academic partners, and biopharma companies. The test is currently being evaluated in several high-impact studies and is performed at the company’s state-of-the-art laboratory facility in Salt Lake City.
1 "Charting the Path to Systemic Therapy De-escalation—Oligometastatic Kidney Cancer as a Paradigm" by Tang and Msaouel PMID: 38451536
About Myriad’s Precise MRD Test
Myriad’s Precise MRD test is a tumor-informed, whole genome sequencing (WGS) based test that monitors hundreds to thousands of tumor-specific variants, enabling exceptional sensitivity and quantification of ctDNA in the blood of patients with cancer. The Precise MRD test can be used to monitor ctDNA levels throughout a cancer patient’s clinical care, starting immediately after diagnosis and continuing through treatment.
About Myriad Oncology
Myriad Oncology provides a portfolio of advanced genetic and tumor genomic testing solutions, including risk assessment, screening, tools to aid treatment guidance, and survivorship planning. The Myriad Oncology offering is designed to meet the unique needs of oncology specialists and their patients across each step in the patient care continuum.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics develops and offers molecular tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular 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 about the study and how it suggests that ultrasensitive ctDNA detection is a promising personalized biomarker that may offer opportunities for de-escalated, personalized care in patients with cancer types that does not otherwise have many good biomarkers, the potential of the company’s ultrasensitive ctDNA MRD assay to offer new possibilities for patients who might be optimal candidates for MRWS in lieu of systemic therapy, potentially reducing serious side effects and high costs, and the company’s optimism regarding Precise MRD’s potential validity and utility in a range of other applications. 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, 2025, 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.
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