Myriad Genetics Announces Precise MRD Clinical Data Published in The Lancet Oncology
Myriad Genetics (NASDAQ: MYGN) announced the publication of clinical data for its Precise MRD test in The Lancet Oncology. The study focused on patients with oligometastatic clear-cell renal cell carcinoma (ccRCC) and demonstrated significant results in detecting circulating tumor DNA (ctDNA).
The Phase 2 trial revealed that 94% of patients had ctDNA levels below 100 ppm at baseline. Patients testing negative with Precise MRD maintained metastasis-directed therapy for a median of 54 months, compared to 27 months for ctDNA-positive patients. Notably, ctDNA-negative patients showed strong survival rates of 94% at two years and 87% at three years.
Myriad Genetics (NASDAQ: MYGN) ha reso noti i dati clinici del suo test Precise MRD, pubblicati su The Lancet Oncology. Lo studio, condotto su pazienti con carcinoma renale a cellule chiare oligometastatico (ccRCC), ha mostrato risultati significativi nella rilevazione del DNA tumorale circolante (ctDNA).
In questo trial di Fase 2 è emerso che il 94% dei pazienti presentava livelli di ctDNA inferiori a 100 ppm al basale. I pazienti risultati negativi al test Precise MRD hanno proseguito la terapia diretta alle metastasi per una mediana di 54 mesi, rispetto ai 27 mesi dei pazienti ctDNA-positivi. Inoltre, i pazienti ctDNA-negativi hanno evidenziato ottime sopravvivenze: 94% a due anni e 87% a tre anni.
Myriad Genetics (NASDAQ: MYGN) ha anunciado la publicación en The Lancet Oncology de los datos clínicos de su test Precise MRD. El estudio, realizado en pacientes con carcinoma renal de células claras oligometastásico (ccRCC), mostró resultados significativos en la detección de ADN tumoral circulante (ctDNA).
En el ensayo de fase 2 se observó que el 94% de los pacientes tenía niveles de ctDNA por debajo de 100 ppm en la línea base. Los pacientes que resultaron negativos con Precise MRD continuaron con terapia dirigida a las metástasis durante una mediana de 54 meses, frente a 27 meses para los pacientes ctDNA-positivos. Cabe destacar que los pacientes ctDNA-negativos presentaron sólidas tasas de supervivencia: 94% a los dos años y 87% a los tres años.
Myriad Genetics (NASDAQ: MYGN)는 The Lancet Oncology에 자사의 Precise MRD 검사 임상 데이터를 발표했습니다. 이 연구는 올리고전이성 투명세포 신세포암(ccRCC) 환자를 대상으로 진행되었으며, 순환종양 DNA(ctDNA) 검출에서 유의한 결과를 보였습니다.
2상 임상에서 94%의 환자가 기저선에서 ctDNA 수치가 100 ppm 미만인 것으로 나타났습니다. Precise MRD 음성 판정을 받은 환자들은 전이 지향 치료를 중앙값 54개월 동안 유지했으며, ctDNA 양성 환자들은 27개월이었습니다. 특히 ctDNA 음성 환자들의 생존율은 2년 차 94%, 3년 차 87%로 높게 나타났습니다.
Myriad Genetics (NASDAQ: MYGN) a annoncé la publication dans The Lancet Oncology des données cliniques de son test Precise MRD. L'étude, menée chez des patients atteints d'un carcinome rénal à cellules claires oligométastatique (ccRCC), a montré des résultats significatifs pour la détection de l'ADN tumoral circulant (ctDNA).
L'essai de phase 2 a révélé que 94% des patients présentaient des niveaux de ctDNA inférieurs à 100 ppm au départ. Les patients négatifs au test Precise MRD ont poursuivi un traitement dirigé contre les métastases pendant une médiane de 54 mois, contre 27 mois pour les patients ctDNA positifs. Notamment, les patients ctDNA négatifs ont affiché d'excellents taux de survie : 94% à deux ans et 87% à trois ans.
Myriad Genetics (NASDAQ: MYGN) hat die Veröffentlichung klinischer Daten zu seinem Precise MRD-Test in The Lancet Oncology bekanntgegeben. Die Studie untersuchte Patienten mit oligometastasiertem klarzelligem Nierenzellkarzinom (ccRCC) und zeigte bedeutende Ergebnisse bei der Detektion von zirkulierender Tumor-DNA (ctDNA).
In der Phase‑2‑Studie hatten 94% der Patienten zu Beginn ctDNA-Werte unter 100 ppm. Patienten, die mit Precise MRD negativ getestet wurden, erhielten metastasenorientierte Therapie für eine Mediandauer von 54 Monaten, im Vergleich zu 27 Monaten bei ctDNA-positiven Patienten. Auffällig waren die guten Überlebensraten der ctDNA-negativen Patienten: 94% nach zwei Jahren und 87% nach drei Jahren.
- Precise MRD test successfully detected ctDNA in patients with very low tumor burden
- Study showed potential for delayed or avoided systemic treatments, reducing side effects
- ctDNA-negative patients showed strong survival rates (94% at 2 years, 87% at 3 years)
- Test demonstrated effectiveness in renal cancer, known for challenging low tumor fraction detection
- ctDNA-positive patients progressed to systemic therapy more quickly (27 months vs 54 months)
Insights
Myriad's Precise MRD test shows promising ability to guide treatment decisions in renal cancer patients, potentially sparing unnecessary systemic therapy.
The publication in The Lancet Oncology represents a significant milestone for Myriad Genetics' Precise MRD test in the management of oligometastatic clear-cell renal cell carcinoma (ccRCC). The study demonstrates that this highly sensitive circulating tumor DNA (ctDNA) test can effectively stratify patients who might benefit from metastasis-directed radiation therapy without systemic treatment.
The data is particularly compelling because renal cancer typically has low tumor fraction, making ctDNA detection challenging with conventional assays. Despite this obstacle, the test showed remarkable performance in detecting ultrasensitive levels of ctDNA -
The clinical impact is substantial: patients who tested negative for ctDNA maintained on metastasis-directed therapy (MDT) for a median of 54 months versus only 27 months for ctDNA-positive patients. This represents a doubling of systemic therapy-free survival. Importantly, this delay in systemic treatment did not compromise survival outcomes, with survival rates of
This study addresses a critical unmet need in renal cancer management - identifying which oligometastatic patients can safely defer or avoid systemic therapy with its accompanying toxicities. The ability to personalize treatment decisions based on molecular evidence could significantly improve patient quality of life while maintaining oncologic outcomes.
The validation in this challenging tumor type also suggests broader applicability of the Precise MRD platform across other cancer types where biomarkers are needed to guide treatment decisions, potentially expanding Myriad's market opportunity beyond renal cancer to indications like breast cancer.
SALT LAKE CITY, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced The Lancet Oncology published a study highlighting the performance of Myriad’s molecular residual disease (MRD) test, Precise® MRD, in patients with oligometastatic clear-cell renal cell carcinoma (ccRCC).
One of the goals of this study was to determine whether patients with oligometastatic ccRCC could benefit from incorporating ultrasensitive MRD testing into their care. The study demonstrated that circulating tumor DNA (ctDNA) levels were associated with patients’ response to metastasis-directed radiation therapy (MDT). Precise MRD was able to detect ctDNA levels in patients with very low tumor burden. This may allow patients who are candidates for metastasis-directed radiotherapy without systemic therapy (MRWS) to delay or avoid systemic treatments, sparing patients from serious side effects and supporting treatment de-escalation.
Key MRD findings from this Phase 2 trial include:
94% of patients tested at baseline had ctDNA levels below 100 ppm, which falls in the ultrasensitive testing range.- Those who tested positive with Precise MRD prior to MRWS progressed to systemic therapy within a median time of 27 months, whereas those who tested negative were maintained on MDT for a median time of 54 months.
- In those who were ctDNA negative and maintained on MDT, overall survival was not compromised, with survival rates of
94% at two years and87% at three years.
“Our study demonstrated that MDT successfully delayed the initiation of systemic therapy in patients with oligometastatic ccRCC,” said Chad Tang, MD, associate professor in the department of genitourinary radiation oncology at The University of Texas MD Anderson Cancer Center (MDACC), and principal investigator of the study. “Median systemic therapy-free survival was nearly double in those who were ctDNA negative compared to those who were ctDNA positive, suggesting that ctDNA may be a promising biomarker to identify those who will benefit most from MDT.”
“Renal cancer is known to have low tumor fraction, making detection of ctDNA difficult for first-generation MRD assays,” said Dale Muzzey, PhD, chief scientific officer, Myriad Genetics. “Using the ultrasensitive Precise MRD Test, we could detect a wide range of ctDNA levels – from very high to very low – that were associated with response to metastasis-driven therapy. We are excited to continue characterizing the performance of Precise MRD in renal cancer, where biomarkers are urgently needed to inform care. The performance of Precise MRD in this challenging clinical setting is an encouraging indicator of its sensitivity in a range of other indications, such as breast cancer.”
About the Study
The study, “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,” was first shared at the 2025 American Association for Cancer Research Annual Meeting. The study was an investigator initiated single-arm trial enrolling patients with ccRCC and up to 5 metastases (NCT03575611). This study is among the largest trials conducted to date in this setting and includes one of the longest follow-up periods evaluating sequential metastasis directed therapy without systemic therapy for ccRCC. The Precise MRD Test was used to evaluate ctDNA levels as part of an exploratory endpoint to determine the association of translational biomarkers with patient outcomes.
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. 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 relating to how the ability of Precise MRD to detect ctDNA levels in patients with very low tumor burden may allow patients who are candidates for MRWS to delay or avoid systemic treatments, sparing patients from serious side effects and supporting treatment de-escalation; that ctDNA may be a promising biomarker to identify those who will benefit most from MDT; that the performance of Precise MRD in this clinical setting is an encouraging indicator of its sensitivity in a range of other indications, such as breast cancer; and the company’s excitement to continue characterizing the performance of Precise MRD in renal cancer. 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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