Performance Evaluation of NSCLC Biomarker Assay

This technical report evaluates the performance of the Aspyre Lung assay, developed by CellCarta in collaboration with Biofidelity, for biomarker testing in non-small cell lung cancer (NSCLC). The report details the assay's capability to detect 114 somatic variants across 11 genes using low input samples from both formalin-fixed paraffin-embedded (FFPE) tissues and liquid biopsies. The methods section outlines the multiplex PCR and rolling circle amplification techniques employed in the assay, as well as the recommended input levels for optimal performance. Results indicate that the Aspyre Lung assay demonstrates high sensitivity, specificity, and analytical accuracy, achieving 0% false positives across extensive variant calls. The report also discusses the assay's validation process, including limit of detection studies and independent evaluations confirming its reliability for clinical trial settings. The findings suggest that Aspyre Lung addresses clinical practice gaps by providing a non-invasive, cost-effective solution for NSCLC biomarker testing, particularly in cases where traditional tissue biopsies are not feasible.