Figure 1. C2inform assay protocol
![](https://oncodna.com/content/uploads/2024/02/c2inform-assay-protocol.png)
Figure 2. Study design
![](https://oncodna.com/content/uploads/2024/02/study-design.png)
Table 1. Patient Characteristics
![](https://oncodna.com/content/uploads/2024/02/patient-characteristic.png)
Figure 3. The association of relapse with presence of ctDNA in (A) the landmark cohort and (B) the EGFR mutated and wild type (WT) subgroups
![](https://oncodna.com/content/uploads/2024/02/association-ctdna-detection-relapse.png)
ctDNA was detected (C2inform positive) in 83% of patients that relapsed (sensitivity 83%), compared to 16% that did not relapse (specificity 84%)
Figure 4. Plasma samples from 43 patients in the landmark cohort were collected post-surgery and analyzed for the presence of ctDNA (C2inform positive). All post-surgery plasma samples are shown.
![](https://oncodna.com/content/uploads/2024/02/landmark-cohort-patient-level-overview.png)
Figure 5. Association of C2inform status at landmark with relapse
![](https://oncodna.com/content/uploads/2024/02/association-ctdna-detection-recurrence-free-survival.png)
![](https://oncodna.com/content/uploads/2024/02/lung-aacr-2022-poster_page-0001-scaled.jpg)
Overview: The pivotal role of early detection of cancer recurrence and the precise monitoring of minimal residual disease (MRD) after surgery cannot be overstated, especially in the context of non-small cell lung cancer (NSCLC) where circulating tumor DNA (ctDNA) plays a critical role in clinical outcomes. To address the challenges of ctDNA detection in NSCLC patients undergoing potentially curative resections, we adopted a cutting-edge whole genome sequencing (WGS) method, MRDetect, designed for unmatched sensitivity and specificity in ctDNA analysis.
Study Design: Our exploratory study aimed to assess the efficacy of the MRDetect method across several key stages: before surgery, immediately after, and during subsequent follow-ups, in patients diagnosed with stage IB-IIIA NSCLC. Participants were monitored through standard computed tomography imaging, while ctDNA was meticulously extracted from plasma samples. The MRDetect technique, leveraging WGS with a tumor-specific approach and enhanced by AI-driven error correction models, was pivotal in distinguishing ctDNA signals amidst a backdrop of low tumor burden, thereby providing a nuanced prognosis for recurrence risk. This study also evaluated the assay’s predictive power for recurrence, based on critical samples collected at a median of 1.6 months post-operation.
Outcomes: The pilot encompassed 52 NSCLC patients, yielding 88 plasma samples over a median follow-up period of 32.6 months. Notably, among 43 patients with critical post-operative samples, the median age was 62, with a predominant male demographic (70%) and a high prevalence of adenocarcinoma (79%) and EGFR mutations (49%). The MRDetect assay demonstrated a commendable sensitivity of 83% in detecting radiological recurrence, including a remarkable 86% sensitivity in patients with EGFR mutations. The median relapse-free survival for patients identified as MRD positive by MRDetect was 15.2 months. Moreover, the assay showcased an 84% specificity in patients without recurrence, with consistent performance across EGFR mutation statuses. Longitudinal analysis further confirmed the assay’s high specificity (93%) in predicting the absence of recurrence.
Conclusion: The MRDetect platform, integrating WGS with sophisticated AI algorithms, proves to be a potent tool in identifying MRD with high accuracy in NSCLC patients, irrespective of EGFR mutation status. As the landscape of adjuvant therapies for NSCLC evolves, possessing such an ultra-sensitive MRD assay is invaluable for personalizing treatment plans, optimizing the selection and timing of adjuvant therapies to enhance patient outcomes.