Personalis NeXT Personal Test Demonstrates Ultrasensitive ctDNA Monitoring Capabilities Across Multiple Cancer Types
Key Insights
Personalis published two studies showing their NeXT Personal (search) test can detect circulating tumor DNA at ultrasensitive levels across 24 different cancer types, with 98% detection rate at baseline.
The test identified molecular response to immunotherapy a median of 23 days after treatment initiation and detected disease progression 161 days before imaging in advanced cancer patients.
Patients achieving durable molecular clearance had 100% overall survival, while those with early ctDNA (search) increases had zero percent overall response rate to immunotherapy.
Personalis has published compelling evidence demonstrating the clinical utility of its ultrasensitive molecular residual disease assay, NeXT Personal (search), in monitoring immunotherapy response across a broad spectrum of solid tumors. Two recent publications highlight the test's ability to detect circulating tumor DNA (ctDNA (search)) at levels that could be missed by less sensitive approaches, potentially enabling earlier clinical intervention.
Breakthrough Detection Capabilities Across Cancer Types
The NeXT Personal (search) test achieved remarkable performance across diverse cancer populations. In a study published in Clinical Cancer Research analyzing 202 patients with stage IV solid tumors spanning 24 different cancer types, the test detected ctDNA (search) in 98% of patients at baseline. This robust performance was maintained across all tumor types, demonstrating the test's broad applicability in advanced cancer management.
The assay uses a personalized approach that tracks up to 1,800 tumor-specific variants unique to each patient's tumor, enabling ultrasensitive detection of small traces of ctDNA (search) from blood samples. This comprehensive genomic profiling approach allows the test to maintain sensitivity even as cancer evolves over time.
Early Molecular Response Predicts Clinical Outcomes
A separate study published in npj Precision Oncology, led by researchers at UC San Diego Moores Cancer Center (search), examined 39 patients with advanced solid tumors across nine different cancer types treated with immune checkpoint inhibitors. The findings revealed that molecular response, defined by ctDNA (search) dynamics, was detectable early—a median of 23 days after starting immunotherapy.
Patients who achieved an early molecular response demonstrated significantly longer progression-free survival compared to those who did not. The study found that patients with decreasing ctDNA (search) levels early in immunotherapy treatment had significantly higher overall survival, while patients with increasing ctDNA levels early during treatment had a zero percent overall response rate.
Superior Lead Time Over Standard Imaging
The NeXT Personal (search) test demonstrated substantial advantages over conventional imaging approaches. For patients whose disease progressed, the test identified molecular progression a median of 161 days—over five months—before imaging could detect the progression. This extended lead time could provide crucial opportunities for treatment modification before clinical deterioration becomes apparent.
Critical Role of Ultrasensitive Detection
The studies emphasized the importance of ultrasensitive detection capabilities, particularly in advanced tumors. Even in advanced cancers where ctDNA (search) shedding can be higher, 33% of positive ctDNA detections occurred in the ultrasensitive range below 100 parts per million (PPM). These detections could be missed with less sensitive testing approaches, potentially leading to delayed recognition of treatment response or progression.
Durable Clearance Correlates with Survival
The most striking finding involved patients who achieved durable molecular clearance, defined as negative ctDNA (search) for at least 180 days. These patients demonstrated 100% overall survival in the Clinical Cancer Research study. Additionally, patients who achieved molecular complete response (ctDNA clearance) had seven times higher overall survival than patients who did not achieve ctDNA clearance.
"We continue to expand the clinical evidence that NeXT Personal (search) can be used to monitor therapy response in advanced cancer patients on immunotherapy," said Richard Chen, M.D., M.S., Chief Medical Officer and Executive Vice President of R&D at Personalis. "This pan-cancer study builds on our recent publication in Clinical Cancer Research, similarly showing the impact of ultrasensitive ctDNA (search) testing in late-stage cancers."
Addressing Immunotherapy Monitoring Challenges
The research addresses a critical clinical need in cancer care. While immunotherapy has transformed cancer treatment, only 10-40% of patients achieve durable benefit, making it essential to monitor patient response effectively. Traditional imaging approaches can be insufficient for detecting early response patterns, particularly given immunotherapy's unique response characteristics.
Dr. Rodrigo Toledo, Group Leader of the Biomarkers and Clonal Dynamics Laboratory at VHIO and senior author of the Clinical Cancer Research study, noted that "immunotherapy has revolutionized cancer care, but response patterns can be difficult to interpret using imaging alone. Our findings show that ultrasensitive ctDNA (search) dynamics provide a clear, early molecular view of benefit or non-response, offering a powerful tool to guide patient management across a broad spectrum of solid tumours."
The studies collectively demonstrate the potential for ultrasensitive ctDNA (search) monitoring to transform cancer management by providing earlier, more precise indicators of treatment response across diverse cancer types and immunotherapy regimens.