A study of 431 patients demonstrates the test can detect cancer recurrence months ahead of standard imaging.
A new study published in Cell demonstrates that ultrasensitive circulating tumor DNA (ctDNA) monitoring can detect lung cancer recurrence months before standard imaging in patients with non-small cell lung cancer (NSCLC).
The study, led by professor Charles Swanton at the Francis Crick Institute and University College London in collaboration with Personalis Inc, analyzed 431 NSCLC patients tracked for a median of more than five years using the NeXT Personal test. Results showed the NeXT Personal test detected cancer recurrence a median of five to nine months, and up to 57 months, ahead of standard imaging post-surgery and during surveillance. The test demonstrated sensitivity and specificity for detecting residual and recurrent cancer throughout the patient course, with 36% to 43% of detections occurring in the ultrasensitive range.
“This latest TRACERx study underscores the critical role of ultrasensitive ctDNA monitoring in early-stage lung cancer,” says professor Charles Swanton, director of the Cancer Research UK Lung Cancer Centre of Excellence and chief clinician at Cancer Research UK, in a release. “The ability to detect residual disease at extremely low levels allows us to detect traces of cancer earlier after surgical resection in the adjuvant setting and more effectively identify patients at risk for relapse.”
Technology Enables Ultrasensitive Detection
The NeXT Personal technology leverages whole-genome sequencing and proprietary noise suppression to detect ctDNA at levels down to approximately 1 part per million. The study found that ctDNA detection pre-treatment, post-surgery, and during surveillance was associated with higher risk of relapse and worse overall survival.
The research also identified an intermediate risk patient subgroup with ultrasensitive ctDNA detections that could benefit from close clinical follow-up. For therapy monitoring, patients who did not clear their ctDNA during adjuvant chemotherapy were more than 5 times more likely to relapse than those who cleared their ctDNA.
“This publication in Cell confirms that NeXT Personal’s high test-sensitivity and specificity are not just technical specifications; they are key to unlocking clinical utility,” says Richard Chen, MD, chief medical officer and executive vice president of R&D at Personalis, in a release. “By pioneering ultrasensitive MRD testing, we are leading the way in enabling the next generation of cancer care and giving physicians the tools they need to better guide treatment decisions throughout the patient journey.”
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