Analysis from TRACERx Study Reveals More Sensitive and Earlier ctDNA Detection in Lung Cancer Patients by Personalis' MRD Technology
NeXT Personal® ctDNA assay shown to be more sensitive and predictive of clinical outcomes in early-stage lung cancer patients
Demonstrates importance of an ultra-sensitive ctDNA approach
The findings come from an analysis by Professor
Lung cancer is the second most common cancer in the
Higher sensitivity for early-stage lung cancer
In this analysis, NeXT Personal showed significantly higher sensitivity in early-stage NSCLC patients compared to two previous publications on the TRACERx cohort. Pre-surgery, the assay demonstrated 100% sensitivity for ctDNA in pre-surgical non-LUAD samples and 81% pre-surgical ctDNA sensitivity for LUAD, one of the most common types of lung cancer but also one of the most challenging to detect in blood. The pre-surgical sensitivity for early-stage LUAD was up to 4X higher than in previous studies on the TRACERx cohort, depending on stage. This high sensitivity enhanced the assay’s ability to detect recurrence and monitor lung cancer effectively.
Ability to identify low and high recurrence risk prior to surgery
The study demonstrated that pre-surgical ctDNA levels with NeXT Personal could be used to classify early-stage lung cancer patients into lower- and higher-recurrence risk groups. Furthermore, the analysis showed that the ultra-low levels of ctDNA detection enabled by NeXT Personal were critical to determining patient recurrence risk. For example, LUAD patients who were ctDNA-negative before surgery with NeXT Personal strikingly exhibited a 100% 5-year overall survival rate and 94% relapse-free survival rate in the TRACERx cohort. In comparison, patients who were ctDNA-positive prior to surgery had a high risk of cancer recurrence over 5 years.
Earlier detection for earlier potential intervention
The results presented at ESMO also showed that NeXT Personal enabled earlier detection of residual or recurrent lung cancer after surgery in the TRACERx cohort. The results show a median lead time of approximately 6 to 11 months for ctDNA detection ahead of traditional imaging, and significantly longer than previous TRACERx results. The ability to identify potential recurrence months earlier offers the possibility to intervene and accelerate treatment in high-risk patients.
The promise of helping lung cancer patients throughout their journey
Overall, the TRACERx results raise the potential of using NeXT Personal to help inform patient management throughout the patient journey, from pre-surgery to post-surgery and longer-term monitoring.
"Existing tests for lung cancer patients often fall short in detecting residual or recurrent cancer early. Our NeXT Personal test is designed to change that by being significantly more sensitive. We are thrilled that the TRACERx results presented at ESMO demonstrated higher sensitivity for the most common types of early-stage lung cancer, including the most challenging subtypes. That sensitivity translated into a better understanding of recurrence risk for patients, and earlier detection of recurrence. We hope that earlier detection can ultimately be life-saving, offering patients a greater chance at successful treatment," said
The NeXT Personal technology leverages whole genome sequencing and advanced noise suppression with NeXT SENSE™ technology to identify a unique genetic signature derived from a patient’s tumor based on up to ~1,800 variants. This unique signature is tracked in the patient’s blood over time to find residual or recurrent cancer, achieving an industry-leading sensitivity of down to ~1 PPM. This enhanced sensitivity offers the potential for earlier recurrence risk assessment and intervention, earlier detection, more precise monitoring, and substantial advancement in lung cancer care.
"Patients often live in fear of undetected cancer leading to a relapse. Our new assay is a transformative leap forward—it's like turning on a spotlight in a previously dark room. It finds what other tests often miss, providing a new level of certainty and peace of mind. This isn't just about technology; it's about giving patients and their families a clearer path forward in their fight against cancer," said
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