Abstract 497: Real world experience of Aspyre Lung (Tissue) LDT: Simplified genomic profiling

Abstract Aspyre Clinical Test for Lung (Tissue) tests lung FFPE and blood samples for actionable biomarkers across 11 genes and 114 variants associated with NSCLC (ALK, BRAF, EGFR, ERBB2, KRAS, MET, RET, ROS1, NTRK1/2/3). The assay uses standard PCR equipment and interrogates RNA and DNA directly for clinically actionable alterations in a cost effective and rapid manner. We present results from the initial cohort of clinical samples sent to Biofidelity Inc. Laboratory (a CAP/CLIA site). De-identified demographic and clinical data were obtained, and collated alongside laboratory data. Clinical sample and internal laboratory processing characteristics analyzed included biopsy type, pathology diagnosis, tumor content, % necrosis, number of slides used, turnaround time (TAT), variant(s) identified, and assay validity. Samples that did not meet all validated requirements were also analyzed separately. 113 clinical samples were analyzed. At the time of data cut-off, mean patient age was 65.9 yrs (range 38-94 yrs), 58 Male, 55 Female, mean tumor content 46% (range 0-95%), mean necrosis 5% (range 0-80%), 15 were resections, 18 FNA, 35 CNB, 4 cytology, 19 cryobiopsies, 11 transbronchial biopsies, 11 unknown. 92% of samples were processed within 2 business days, with an average of 5.7 slides (cut at 5 µm) used (median 4). 64 samples were adenocarcinoma/ adenosquamous, 24 samples were squamous cell carcinoma, 1 spindle cell carcinoma, 7 NSCLC, 1 small cell carcinoma and 16 not known or no pathology report. Overall, 49 samples were positive for a variant, and 64 had no variant identified. Variants included SNV in BRAF, EGFR, and KRAS, EGFR exon 19 deletions and exon 20 insertions, MET exon 14 skipping and gene fusions. Aspyre Clinical Test for Lung has a high assay success rate and proven rapid 2-day TAT. This makes it suitable as a first-line testing option, or for samples that are scant, of low quality, or fail next-generation sequencing (NGS) quality control, and can provide a large fraction of NSCLC patients with actionable biomarker information. The Aspyre assay is uniquely suited to inform patient decisions using very small samples that are not otherwise amenable to comprehensive genomic profiling by NGS. Aspyre Clinical Test for Lung simplified genomic profiling is transformative for cancer care management, and enables more patients with NSCLC to benefit from more effective and better tolerated targeted therapies. Citation Format: Elizabeth Gillon-Zhang, Eleanor Gray, Ryan Evans, Julia Brown, Candace King, Katherine Knudsen, Ethan Clark, Mary Beth Rossi, Cory Kiser, Amanda Green, Honey V. Reddi, Barnaby Balmforth, Jeffrey Gregg, Wendy Levin, Shari Brown. Real world experience of Aspyre Lung (Tissue) LDT: Simplified genomic profiling [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 497.