Clinical results show high sensitivity for colorectal cancer relapse and ultra-low detection limits for lung cancer.


Personalis Inc announced clinical data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating the performance of its NeXT Personal molecular residual disease (MRD) test across multiple solid tumor types. The findings, led by studies in colorectal and lung cancers, emphasize the clinical utility of detecting circulating tumor DNA (ctDNA) at ultra-low levels.

The prospective VICTORI study, led by the University of British Columbia, monitored more than 100 Stage I-IV resectable colorectal cancer patients. According to an interim analysis, the test showed 100% sensitivity for cancer relapse during surveillance, detecting all relapses ahead of clinical imaging. The test also demonstrated 82% landmark sensitivity four weeks after surgery for patients who later relapsed, providing an early signal to inform treatment pathways.

“Our ASCO data continues to build on a compelling body of evidence, including recent landmark publications, that show ultrasensitive MRD detection with NeXT Personal enables early detection of patients at risk for relapse, across a broad set of solid tumor types,” says Richard Chen, MD, MS, president and chief medical officer of Personalis, in a release.

Detection Limits in Lung Cancer

In an oral presentation using the TRACERx cohort, investigators from University College London analyzed 431 Stage IA-IIIB non-small cell lung cancer patients. The study showed a median limit of detection of 1.66 parts per million (ppm).

The analysis found that approximately 21% of pre-operative adenocarcinoma and 18% of post-operative landmark detections were below 10 ppm. Patients with post-operative detections below 10 ppm experienced a 3-fold increased risk of recurrence compared to patients with undetectable ctDNA, according to the press release.

Evidence Across Solid Tumors

Presentations at the meeting also highlighted the performance of the test in other tumor types:

  • Ovarian Cancer: In a study of 72 patients with high-grade epithelial ovarian cancer evaluated after chemotherapy and surgery, ctDNA detection correlated with a 3.5-fold risk increase for progression.

  • Endometrial Cancer: Investigators at MD Anderson Cancer Center found that ctDNA clearance post-treatment in 99 patients reduced recurrence risk 29-fold.

  • Melanoma: A study of 98 patients showed that increasing ctDNA during adjuvant therapy was associated with a 5-fold higher risk of distant metastasis. Ultrasensitive monitoring identified recurrences a median of 212 days prior to imaging.

  • Renal Cell Carcinoma: In advanced cases, the test showed a pre-treatment baseline detection rate of 84%. Patients who did not achieve molecular ctDNA clearance during first-line therapy experienced a seven-fold increase in the risk of progression and a nearly 4-fold increase in the risk of death.

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