Personalis Publishes Landmark TRACERx Study Showing NeXT Personal Test Detects Lung Cancer Relapse Months Ahead Of Imaging

Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for precision oncology, today announced the publication of one of the largest and most comprehensive patient cohorts to date from the landmark TRACERx study, in the journal Cell. The study, titled "Longitudinal ultrasensitive ctDNA monitoring for high-resolution lung cancer risk prediction," demonstrates the clinical importance of ultrasensitive, tumor-informed molecular residual disease (MRD) testing in stage I to III non-small cell lung cancer (NSCLC).

The study, led by Professor Charles Swanton at the Francis Crick Institute and University College London (UCL) in collaboration with Personalis, analyzed 431 NSCLC patients tracked for a median of > 5 years using the NeXT Personal® test. It demonstrated that the NeXT Personal test allows for highly sensitive detection of small traces of circulating tumor DNA (ctDNA) in blood samples from lung cancer diagnosis through to surveillance, even in hard-to-detect subtypes.

Key Findings:

• Comprehensive Cancer Detection From Diagnosis Through Surveillance: NeXT Personal demonstrated exceptional sensitivity and specificity for detecting residual and recurrent cancer throughout the patient course at diagnosis (pre-surgery), post-surgical (landmark), during adjuvant, and during long-term surveillance monitoring, with many of the detections (~36-43%) in the ultrasensitive range.
• Cancer Detection Ahead of Imaging: Cancer was detected a median of ~5 to ~9 months and up to ~57 months ahead of standard of care imaging post-surgery and during surveillance.
• Ultrasensitive Detection and Risk Stratification: The study demonstrated NeXT Personal detection of ctDNA pre-treatment, post-surgery, and during surveillance was associated with higher risk of relapse and worse overall survival. The study also identified an intermediate risk patient subgroup with ultrasensitive ctDNA detections that can benefit from close clinical follow-up.
• Therapy Monitoring: Patients who did not clear their ctDNA during adjuvant chemotherapy were > 5 times more likely to relapse than those who cleared their ctDNA.

The study utilized Personalis' NeXT Personal technology, which leverages whole-genome sequencing and proprietary noise suppression to detect ctDNA at levels down to ~1 PPM. The Cell publication highlights that a significant portion of relapsing patients presented with ctDNA levels in the ultrasensitive range, detections which can be missed with less sensitive tests.