Successful simplified genomic profiling of cytology specimens using Aspyre Clinical Test for Lung (Tissue)

Mon, 08 Jun 2026 00:05:07 -0700

Cytology specimens from patients with non–small cell lung cancer were tested using Aspyre Clinical Test for Lung (Tissue) and the results compared to an orthogonal assay. 84/85 samples passed quality control, and all detected variants matched expected results including SNVs from KRAS, SNVs and indels from EGFR, MET exon 14 skipping and gene fusions in ROS1 and ALK. These findings support the use of Aspyre Clinical Test for Lung (Tissue) with minimally invasive cytology specimens to obtain reliable first-line genomic profiling, facilitating timely decision-making and preserving scarce tumor tissue.

Abstract

Background

Testing patients with non–small cell lung cancer for actionable variants is essential for guiding treatment decisions in accordance with established cancer care guidelines, though limited quantity and quality of tumor tissue often leaves insufficient material for comprehensive testing. Cytopathology specimens obtained through minimally invasive techniques are a potential source of diagnostic material for genomic profiling, though typically challenging to analyze.

Methods

A total of 85 DNA or total nucleic acid non–small cell lung cancer samples derived from 45 fine-needle aspirate rinse or pleural fluid samples from the Hospital of the University of Pennsylvania archive were tested using the Aspyre Clinical Test for Lung (Tissue) in Biofidelity’s CAP/CLIA laboratory. All samples were previously characterized by the Oncomine Precision Assay Genexus assay (the orthogonal reference method).

Results

Eighty-four of 85 passed Aspyre Lung quality control, one failed. Twenty-six samples were positive for variants in the Aspyre Lung panel: 17 for single nucleotide variants (KRAS, EGFR), three for EGFR insertions/deletions, two for MET exon 14 skipping, and five for gene fusions. Eighty-two of 85 samples were run at standard input levels; three of 85 were run at low input but passed Aspyre Lung controls and include one EGFR exon 20 insertion variant-positive. All results were concordant between methods. Positive Percent Agreement and Negative Percent Agreement were 100%.

Conclusions

Aspyre Clinical Test for Lung performs effectively on samples derived from fine needle aspirate rinses and pleural fluid. Using these cytology-based specimens for biomarker testing enables pathologists to perform simplified genomic profiling while preserving valuable tissue specimens, potentially reducing the need for additional invasive procedures.

Issue Information

Mon, 08 Jun 2026 00:02:24 -0700

No abstract is available for this article.