Personalis and Royal Marsden Study Advances Early-Stage Breast Cancer Detection with NeXT Personal® ctDNA Test
ICR and Royal Marsden Study Highlights ctDNA Testing
Introduction: Advancements in Breast Cancer Detection
Personalis, Inc. has partnered with renowned researchers from The Institute of Cancer Research (ICR), London, and The Royal Marsden NHS Foundation Trust in the UK to publish groundbreaking results in the Annals of Oncology. The study explores advancements in the detection of minimal residual disease (MRD) and recurrence in early-stage breast cancer using Personalis’ NeXT Personal® assay, a highly sensitive personalized test designed to identify small traces of circulating tumor DNA (ctDNA) in the blood. This approach offers new hope for early detection and management of breast cancer, which is the most common cancer in the U.S., with approximately 300,000 new cases and 40,000 deaths projected for 2024, according to the U.S. National Cancer Institute (NCI).
NeXT Personal®: A Personalized Approach to ctDNA Detection
The NeXT Personal test represents a leap forward in cancer detection. It uses whole-genome sequencing of a patient’s tumor to create a personalized test that identifies a unique genetic fingerprint specific to that individual’s cancer. The test can then recognize this fingerprint from a blood sample, offering ultra-sensitive detection of ctDNA at levels as low as 1 part per million (PPM). This personalized approach makes it possible to identify even the smallest traces of cancer cells, enabling clinicians to detect residual or recurrent cancer far earlier than conventional methods like radiographic imaging.
Study Design and Patient Cohort
In this landmark study, the NeXT Personal test was used to analyze blood samples from a cohort of 78 patients with early-stage breast cancer. The cohort included a variety of breast cancer subtypes, such as triple-negative breast cancer (TNBC), HER2+, and hormone receptor-positive (HR+) breast cancers. This diversity in the study population allowed the researchers to assess the test’s performance across different breast cancer types.
The results demonstrated that NeXT Personal has a remarkable ability to detect early-stage breast cancer with high sensitivity. Approximately 39% of the total detections occurred in the ultra-sensitive range below 100 PPM, illustrating the test’s capacity to identify even the smallest amounts of ctDNA in the blood. More notably, NeXT Personal detected 100% of the patients who had breast cancer recurrence—on average, 15 months and up to 5 years before standard radiographic imaging could detect it. This indicates that the test could potentially allow for earlier intervention, improving treatment outcomes for patients.
Key Findings: Sensitivity and Accuracy
The study’s results underline the unparalleled sensitivity and accuracy of NeXT Personal in detecting breast cancer recurrence. The test detected all patients who experienced recurrence, highlighting its ability to spot cancer long before it would be visible through conventional imaging. Additionally, the study showed that patients who tested negative with NeXT Personal throughout the study period remained disease-free, demonstrating the test’s reliability in ruling out cancer recurrence. This is a significant achievement, as current diagnostic methods can miss early signs of cancer recurrence, leading to delayed treatment.
NeXT Personal: Pioneering Ultra-Sensitive ctDNA Detection
Dr. Isaac Garcia-Murillas, Senior Staff Scientist in the Molecular Oncology Group at The Institute of Cancer Research, London, and the first author of the study, commented on the importance of the NeXT Personal approach. “Most personalized liquid biopsies currently use whole exome sequencing to identify mutations, but NeXT Personal goes a step further,” he explained. “By using whole genome sequencing, we can identify up to 1,800 mutations in a patient’s tumor DNA. This allows us to uniquely track the recurrence of cancer from a blood sample with unprecedented sensitivity.” He also noted that NeXT Personal demonstrated the best MRD performance observed in the study cohort, highlighting its potential to revolutionize breast cancer care by providing earlier insights into recurrence.
Clinical Implications: Changing Breast Cancer Care
The study’s findings offer promising implications for clinical practice, particularly in the management of early-stage breast cancer. NeXT Personal’s ultra-sensitive ctDNA detection capability could be instrumental in guiding treatment decisions, allowing for the escalation or de-escalation of therapies based on the earliest signs of cancer recurrence. Early detection of recurrence could enable clinicians to initiate treatment at the most optimal time, potentially improving patient outcomes and survival rates.
Richard Chen, MD, MS, Chief Medical Officer and Executive Vice President of R&D at Personalis, emphasized the importance of these findings. “We designed NeXT Personal to detect residual or recurrent cancer in its earliest stages,” he said. “This study shows the clinical significance of ultra-sensitive ctDNA detection in early-stage breast cancer. By detecting recurrence well ahead of traditional imaging, we can offer patients timely interventions, leading to better treatment outcomes and potentially providing additional peace of mind for those who test negative.”
ICR and Royal Marsden Study Highlights ctDNA Testing
Looking Ahead: Expanding Access to NeXT Personal®
With the publication of these exciting results, Personalis is now focusing on expanding access to NeXT Personal for breast cancer patients. The study has laid the groundwork for future reimbursement approval, making NeXT Personal a viable option for more patients in clinical practice. Dr. Chen stated, “This landmark publication is an important step toward ensuring that NeXT Personal becomes accessible to a broader patient population. We hope to work with healthcare providers and payers to secure approval for its use in early-stage breast cancer, which could lead to better, more proactive care for patients.”
Conclusion: A New Era in Breast Cancer Detection
The study published in Annals of Oncology represents a significant milestone in the detection and management of early-stage breast cancer. Personalis’ NeXT Personal test, with its personalized, ultra-sensitive ctDNA detection, has the potential to change the way clinicians monitor and treat breast cancer. By identifying recurrence months or even years before conventional imaging, the test could help save lives by enabling earlier treatment. As the research continues to show promising results, expanding access to this cutting-edge technology will be crucial in the ongoing fight against 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 Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).
About the Institute of Cancer Research, London
The Institute of Cancer Research, London, is one of the world’s most influential cancer research organisations.
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 London, it is one of the UK’s leading higher education institutions, placing first for biological sciences and second overall in the definitive ‘REF2021’ rankings of UK university research quality, impact and environment, and provides postgraduate higher education of international distinction.
The ICR’s mission is to make the discoveries that defeat cancer.
For more information visit ICR.ac.uk
