Natera, Inc. announced a new study published in The Journal of Thoracic and Cardiovascular Surgery demonstrating the ability of Natera's personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to risk stratify and detect recurrence early in patients with resected stage I-II non-small cell lung cancer (NSCLC). Worldwide, lung cancer is the second most commonly diagnosed cancer. In the U.S., NSCLC accounts for 81% of all lung cancer diagnoses.

About 25-30% of NSCLC patients are diagnosed with stage I-II disease. These patients typically undergo curative-intent complete surgical resection and may be treated with adjuvant systemic therapy. Key findings include: Patients who were ctDNA-positive within 6 months post-resection and prior to adjuvant treatment were 53-times more likely to recur (p. ctDNA detection demonstrated a median lead time of 5.5 months when compared to confirmation of recurrence by radiographic imaging.

Post-operative surveillance strategies were altered in 100% of ctDNA-positive patients (earlier radiographic imaging), and patients with PET scans positive for malignant features received early referrals for treatment. The study builds on previous Signatera data across early- and late-stage NSCLC. This includes a 2023 publication in Frontiers in Oncology, demonstrating Signatera's ability to risk stratify and detect progression early in unresectable NSCLC, as well as the EMPower Lung-1 trial presented at the 2023 ASCO annual meeting, which showed Signatera's ability to monitor response to immunotherapy and predict clinical outcomes in advanced NSCLC patients.

This recent work also builds upon the 2017 TRACERx Nature publication that first reported Signatera's ability to detect relapse early with high sensitivity and specificity in patients with resected NSCLC.