New Publication from ICR and Royal Marsden Researchers Highlights the Importance of Ultra-Sensitive ctDNA Testing for Early-Stage Breast Cancer Recurrence Detection
Personalis (Nasdaq: PSNL) has published groundbreaking study results in Annals of Oncology, showcasing their NeXT Personal® ultra-sensitive ctDNA blood test for breast cancer detection. The study, conducted with The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust, analyzed 78 early-stage breast cancer patients.
Key findings demonstrate that NeXT Personal detected cancer recurrence with 100% accuracy, approximately 15 months ahead of standard imaging, with some cases detected up to 5 years earlier. The test utilizes whole-genome sequencing to identify up to 1,800 tumor variants, achieving sensitivity down to 1 part per million of ctDNA. Notably, 39% of detections occurred in the ultra-sensitive range below 100 PPM.
The study included patients with triple-negative, HER2+, and HR+ breast cancers. Importantly, all patients who tested negative remained disease-free throughout the study period. This research is particularly significant given breast cancer's status as the most common cancer in the U.S., with projected 300,000 new cases and 40,000 deaths in 2024.
Personalis (Nasdaq: PSNL) ha pubblicato risultati di studio innovativi negli Annals of Oncology, mostrando il loro test del sangue ultra-sensibile NeXT Personal® per la rilevazione del cancro al seno. Lo studio, condotto con l'Istituto di Ricerca sul Cancro di Londra e il Royal Marsden NHS Foundation Trust, ha analizzato 78 pazienti con cancro al seno in fase precoce.
I risultati chiave dimostrano che NeXT Personal ha rilevato la recidiva del cancro con 100% di accuratezza, circa 15 mesi prima rispetto all'imaging standard, con alcuni casi rilevati fino a 5 anni prima. Il test utilizza il sequenziamento dell'intero genoma per identificare fino a 1.800 varianti tumorali, raggiungendo una sensibilità fino a 1 parte per milione di ctDNA. È interessante notare che il 39% delle rilevazioni è avvenuto nella gamma ultra-sensibile sotto 100 PPM.
Lo studio ha incluso pazienti con cancro al seno triplo negativo, HER2+ e HR+. È importante sottolineare che tutti i pazienti testati negativi sono rimasti liberi dalla malattia per tutto il periodo dello studio. Questa ricerca è particolarmente significativa dato lo status del cancro al seno come il cancro più comune negli Stati Uniti, con una previsione di 300.000 nuovi casi e 40.000 decessi nel 2024.
Personalis (Nasdaq: PSNL) ha publicado resultados de estudios innovadores en los Annals of Oncology, mostrando su prueba de sangre ultra-sensible NeXT Personal® para la detección del cáncer de mama. El estudio, realizado con el Instituto de Investigación del Cáncer de Londres y el Royal Marsden NHS Foundation Trust, analizó a 78 pacientes con cáncer de mama en etapas tempranas.
Los hallazgos clave demuestran que NeXT Personal detectó la recurrencia del cáncer con 100% de precisión, aproximadamente 15 meses antes que las imágenes estándar, con algunos casos detectados hasta 5 años antes. La prueba utiliza secuenciación del genoma completo para identificar hasta 1,800 variantes tumorales, logrando una sensibilidad de hasta 1 parte por millón de ctDNA. Notablemente, el 39% de las detecciones ocurrió en el rango ultra-sensible por debajo de 100 PPM.
El estudio incluyó pacientes con cáncer de mama triple negativo, HER2+ y HR+. Es importante destacar que todos los pacientes que dieron negativo permanecieron libres de enfermedad durante todo el período del estudio. Esta investigación es particularmente significativa dado que el cáncer de mama es el cáncer más común en EE. UU., con proyecciones de 300,000 nuevos casos y 40,000 muertes en 2024.
Personalis (Nasdaq: PSNL)는 NeXT Personal® 초민감 ctDNA 혈액 검사를 통한 유방암 검출의 혁신적인 연구 결과를 Annals of Oncology에 발표했습니다. 이 연구는 런던의 암 연구소와 로열 마스든 NHS 재단 신뢰와 함께 진행되었으며, 78명의 초기 유방암 환자를 분석했습니다.
주요 발견은 NeXT Personal이 암 재발을 100% 정확도로 감지했으며, 표준 이미징보다 약 15개월 앞선 결과를 보여주고, 일부 경우는 최대 5년 더 일찍 감지되었습니다. 이 검사는 전체 유전체 시퀀싱을 사용하여 최대 1,800개의 종양 변이를 식별하며, ctDNA의 1백만 분의 1까지 민감도를 달성합니다. 특히, 39%의 감지는 100 PPM 이하의 초민감 범위에서 발생했습니다.
이 연구는 삼중 음성, HER2+ 및 HR+ 유방암 환자를 포함했습니다. 특히, 음성 반응을 보인 모든 환자는 연구 기간 동안 질병이 없었습니다. 이 연구는 유방암이 미국에서 가장 흔한 암으로, 2024년에 300,000건의 신규 사례와 40,000건의 사망이 예상된다는 점에서 특히 중요합니다.
Personalis (Nasdaq: PSNL) a publié des résultats d'étude révolutionnaires dans les Annals of Oncology, mettant en avant leur test sanguin ultra-sensible NeXT Personal® pour la détection du cancer du sein. L'étude, réalisée en collaboration avec l'Institut de recherche sur le cancer de Londres et la Royal Marsden NHS Foundation Trust, a analysé 78 patients atteints de cancer du sein à un stade précoce.
Les résultats clés montrent que NeXT Personal a détecté la récidive du cancer avec une précision de 100%, environ 15 mois avant les méthodes d'imagerie standard, avec certains cas détectés jusqu'à 5 ans plus tôt. Le test utilise le séquençage de l'ensemble du génome pour identifier jusqu'à 1 800 variantes tumorales, atteignant une sensibilité allant jusqu'à 1 partie par million de ctDNA. Notamment, 39% des détections se sont produites dans la plage ultra-sensible en dessous de 100 PPM.
L'étude a inclus des patients atteints de cancers du sein triple négatif, HER2+ et HR+. Il est important de noter que tous les patients testés négatifs sont restés sans maladie pendant toute la durée de l'étude. Cette recherche est particulièrement significative compte tenu du statut du cancer du sein comme le cancer le plus courant aux États-Unis, avec une projection de 300 000 nouveaux cas et 40 000 décès en 2024.
Personalis (Nasdaq: PSNL) hat bahnbrechende Studienergebnisse in den Annals of Oncology veröffentlicht, die ihren NeXT Personal® ultrasensiblen ctDNA-Bluttest zur Erkennung von Brustkrebs zeigen. Die Studie, die in Zusammenarbeit mit dem Institute of Cancer Research in London und dem Royal Marsden NHS Foundation Trust durchgeführt wurde, analysierte 78 Patienten mit Brustkrebs im Frühstadium.
Die wichtigsten Ergebnisse zeigen, dass NeXT Personal Krebsrezidive mit 100% Genauigkeit erkannte, etwa 15 Monate früher als bei herkömmlichen Bildgebungsverfahren, wobei einige Fälle bis zu 5 Jahre früher erkannt wurden. Der Test nutzt das gesamte Genomsequenzieren, um bis zu 1.800 Tumorvarianten zu identifizieren und erreicht eine Sensitivität von bis zu 1 Teil pro Million ctDNA. Bemerkenswert ist, dass 39% der Erkennungen im ultrasensiblen Bereich unter 100 PPM erfolgten.
Die Studie umfasste Patienten mit triple-negativem, HER2+ und HR+ Brustkrebs. Wichtig ist, dass alle Patienten, die negativ getestet wurden, während des gesamten Studienzeitraums gesund blieben. Diese Forschung ist besonders bedeutend, da Brustkrebs die häufigste Krebsart in den USA ist, mit geschätzten 300.000 neuen Fällen und 40.000 Todesfällen im Jahr 2024.
- 100% accuracy in detecting cancer recurrence
- Detection 15 months ahead of standard imaging
- Ultra-high sensitivity (1 part per million)
- Strong potential for reimbursement approval
- None.
Insights
The publication in Annals of Oncology represents a significant clinical validation milestone for Personalis's NeXT Personal blood test in breast cancer monitoring. The performance metrics are truly remarkable from a clinical perspective – 100% detection rate of recurrences with perfect negative predictive value, detection sensitivity down to
What makes this technology particularly noteworthy is its whole-genome approach identifying up to 1,800 tumor-specific mutations, substantially more comprehensive than competing exome-based approaches. This technical differentiation explains the ultra-sensitive detection capability, with
For context, early detection in breast cancer recurrence is critically important for treatment success. The 15-month lead time could translate to significantly improved outcomes by allowing intervention when tumor burden is minimal. The perfect negative predictive value also offers valuable clinical utility by providing high confidence that negative test results truly indicate absence of disease.
This publication represents a critical commercial milestone that directly impacts Personalis's path to market. With breast cancer affecting approximately 300,000 new patients annually in the US alone, the addressable market is substantial. The CMO's statement about this publication "paving the way toward reimbursement approval" is particularly significant as reimbursement coverage is the primary gatekeeper to commercial adoption for advanced diagnostics.
The unique selling proposition here is clear: earlier detection with higher sensitivity than standard approaches. The study demonstrates that NeXT Personal can detect recurrence up to 5 years before standard imaging – creating a substantial clinical value proposition that supports premium pricing potential and helps justify reimbursement.
While promising, the 78-patient sample size suggests this is an intermediate validation step. Typically, payers require more extensive evidence before broad coverage decisions. However, this publication provides important proof-of-concept data that could accelerate enrollment in larger validation studies and increase interest from oncology practices and cancer centers seeking improved monitoring tools.
The application in multiple breast cancer subtypes (triple-negative, HER2+, and HR+) also broadens the potential market application, allowing Personalis to address the full spectrum of breast cancer survivors requiring monitoring.
The findings of this study highlight the potential for using NeXT Personal in guiding management of breast cancer, currently the most common cancer in the
In this study, NeXT Personal was used to analyze blood samples from a cohort of 78 patients with early-stage breast cancer. The cohort included patients with triple-negative breast cancer (TNBC), HER2+, and HR+ breast cancers. The NeXT Personal test showed high sensitivity for detecting early-stage breast cancer with ~
First author, Dr. Isaac Garcia-Murillas, Senior Staff Scientist in the Molecular Oncology Group at The Institute of Cancer Research,
“We designed NeXT Personal to detect residual or recurrent cancer in its earliest stages. This study shows the clinical importance of ultra-sensitive ctDNA detection in early-stage breast cancer,” said Richard Chen, MD, MS, Chief Medical Officer and Executive Vice President of R&D at Personalis. “With the ability to detect breast cancer recurrence well ahead of standard of care imaging, we can potentially help patients receive treatment sooner for their cancer, or give patients additional peace of mind with a negative test.”
Dr. Chen added, “With these exciting results, expanding access to NeXT Personal for breast cancer patients becomes a priority. This landmark publication paves the way toward reimbursement approval for NeXT Personal in early stage breast cancer.”
About Personalis, Inc.
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in
About the Institute of Cancer Research,
The Institute of Cancer Research,
Scientists and clinicians at The Institute of Cancer Research (ICR) are working every day to make a real impact on cancer patients' lives. Through its unique partnership with The Royal Marsden NHS Foundation Trust and 'bench-to-bedside' approach, the ICR is able to create and deliver results in a way that other institutions cannot. Together the two organisations are rated in the top four centres for cancer research and treatment globally.
The ICR has an outstanding record of achievement dating back more than 100 years. It provided the first convincing evidence that DNA damage is the basic cause of cancer, laying the foundation for the now universally accepted idea that cancer is a genetic disease. Today it is a world leader at identifying cancer-related genes and discovering new targeted drugs for personalised cancer treatment.
The ICR is a charity and relies on support from partner organisations, funders and the general public. A member institution of the University of
The ICR's mission is to make the discoveries that defeat cancer.
For more information visit ICR.ac.uk
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FAQ
What accuracy rate did Personalis (PSNL) NeXT Personal test achieve in detecting breast cancer recurrence?
How much earlier can PSNL's NeXT Personal detect breast cancer recurrence compared to standard imaging?
How many variants can Personalis (PSNL) NeXT Personal test identify in tumor DNA?
What types of breast cancer patients were included in the PSNL NeXT Personal study?
