Rapid Agena iPLEX HS Lung Panel Demonstrates High Concordance With Next-Generation Sequencing and Accelerated Turnaround for Precision Treatment for Lung Cancer
Key Clinical Takeaways
- Design/Population: The Agena iPLEX HS Lung Panel was validated for clinical use using 109 lung cancer specimens previously characterized by NGS. Samples included FFPE tumor tissue, resections, and fine-needle aspirates.
- Key Outcomes: The assay achieved 97% to 100% sensitivity and 100% specificity for targeted variants, with a limit of detection of 1% to 3% VAF. All assays were completed within 72 hours of receipt.
- Clinical Relevance: The Rapid iPLEX HS Lung Panel provides an accurate, efficient, and clinically actionable platform for molecular testing in lung cancer, offering NGS-level accuracy with a faster, more cost-effective workflow suitable for routine clinical practice.
According to findings from a validation study, the Agena Bioscience iPLEX HS Lung Panel, which runs on the MassARRAY MALDI-TOF mass spectrometer and detects 70 somatically acquired recurrent variants, demonstrated robust analytical performance and rapid turnaround for detecting clinically actionable key molecular alterations among patients with lung cancer, better enabling the implementation of targeted therapies.
These results were presented by Laila Mnayer, PhD, Hartford Hospital, Hartford, Connecticut, at the 2025 Association for Molecular Pathology (AMP) Annual Meeting and Exposition in Boston, Massachusetts.
In this single-institution study, researchers collected 109 previously NGS-characterized clinical samples and extracted formalin-fixed, paraffin-embedded (FFPE) tumor-enriched samples (including tissue biopsies, resections, and fine-needle aspirates samples) using a minimum of 5 ng of DNA. Samples were then run through the panel and analyzed for sensitivity and specificity across variants.
At analysis, the panel achieved 97% to 100% sensitivity and 100% specificity across all interrogated variants. All samples previously confirmed negative by NGS (n = 19) were confirmed negative, and clinically relevant alterations were accurately identified across multiple genes, including:
- EGFR: All 14 exon 19/28 deletions or indels (variant allele frequency [VAF], 3.9% to 68%), 9 exon 20 missense mutations, and 10 exon 20 insertions were correctly identified.
- HER2: The recurrent exon 20 insertion (p.A775_G776insYVMA) was detected in 10 specimens (VAF, 11% to 86%).
- BRAF: Ten specimens harboring Class I to III pathogenic variants were accurately detected.
- KRAS: Ninety-seven percent of specimens with pathogenic variants (VAF, 2.8% to 69.1%) were correctly identified.
- PIK3CA: All 13 variants (p.E545K or p.H1047L/R; VAF, 7.6% to 73.4%) were detected.
The limit of detection for the assay ranged from 1% to 3% VAF, depending on variant type, and the assay workflow was completed within 72 hours.
As Dr Mnayer concluded, “concordance with NGS results in 109 previously characterized clinical specimens was excellent [and] the Rapid Lung panel (Agena iPLEX) has significantly improved workflow in the molecular pathology laboratory.”
Source:
Mnayer L, DeCarolis M, Nemic E, et al. Introduction of a rapid lung molecular panel into the molecular laboratory workflow significantly improves turnaround time of delivery of actionable results in lung cancer. Presented at the 2025 AMP Annual Meeting. November 11-15, 2025; Boston, Massachusetts. ST037.
