Performance of Aspyre Lung on cytology specimens.

e15069 Background: For patients with Non-Small Cell Lung Cancer (NSCLC), testing for actionable variants is essential to guiding therapeutic treatment plans in alignment with established cancer care guidelines. Tumor tissue for pathologic diagnosis is required, however, limited availability often leaves many patients with insufficient material for genomic testing, leading to the use of cytotoxic chemotherapy instead of effective and better-tolerated targeted therapies. Technologies capable of rapidly providing genomic data from scant tissue samples represent an unmet need in the patient journey for making timely clinical care decisions. Cytopathology specimens and fine-needle aspirations (FNA) are common techniques for obtaining diagnostic material as they are less-invasive than excisional biopsies, but samples are minimal and often contain only small numbers of tumor cells, posing challenges for comprehensive genomic testing. Methods: In this study a NSCLC patient sample set, consisting of 67 DNA or TNA samples from 36 patients from the Hospital of the University of Pennsylvania, was evaluated on the Aspyre Clinical Test for Lung in Biofidelity’s CAP/CLIA laboratory. Samples were remnant nucleic acid derived from FNA rinses or pleural fluid previously characterized by NGS using Oncomine Precision Assay on the Ion Torrent Genexus System (ThermoFisher). Samples were tested by Aspyre at 20ng DNA and 6 ng TNA, except for three run at lower inputs. Results: 66 DNA or TNA samples passed Aspyre Lung QC, one failed. 21 samples were positive for variants in the Aspyre Lung panel: 16 for single nucleotide variants (KRAS, EGFR), three insertions/deletions (EGFR), one for MET exon 14 skipping, and one ROS1 gene fusion. Three low input samples (one DNA, two TNA) all passed Aspyre Lung QC; the DNA low input sample was positive for an EGFR exon 20 insertion. All Aspyre Lung results were concordant with NGS. Conclusions: We demonstrate that Aspyre Clinical Test for Lung, a unique simplified genomic profiling platform for fast and affordable biomarker testing, performs effectively on cytopathology samples containing limited cellular material. The use of these samples for biomarker testing enables pathologists to preserve valuable tissue specimens while minimizing the need for additional invasive patient procedures. The Aspyre Clinical Test for Lung is a robust platform for analyzing these sample types, delivering actionable biomarker results comparable to NGS in cases where limited input poses a challenge.