Summary: Several studies validated Biofidelity’s Aspyre Lung diagnostic technology, showcasing its ability to provide reliable genomic profiling for actionable NSCLC variants.
Takeaways:
- High Accuracy: Aspyre Lung demonstrated 100% concordance with NGS in detecting actionable NSCLC variants, with 100% sensitivity and specificity even in low-tumor-content samples.
- Rapid Adoption: The technology is easily implemented in external laboratories, delivering reliable results from challenging samples within days.
- Clinical Impact: Aspyre Lung’s superior sensitivity identified variants missed by other methods, highlighting its potential to enhance clinical and research outcomes.
Biofidelity, a genomic solutions provider, announced the publication of data that highlights how Aspyre diagnostic technology addresses the urgent need for rapid, accessible molecular diagnostics informing actionable genomic variants in cancer.
“These studies demonstrate that Aspyre Lung solves many of the insurmountable issues that exist with current molecular testing methods, while delivering consistent and reliable results from challenging samples,” says Biofidelity Co-Founder and CEO Barnaby Balmforth, PhD. “Aspyre Lung is an entirely new category of molecular testing, Simplified Genomic Profiling (SGP) that provides simplicity, speed, reliability and ease of adoption.”
Studies Evaluating Aspyre Technology
Validation of a simple, fast, robust, and novel method for multi-variant genomic analysis of actionable NSCLC variants in FFPE tissue published in Frontiers in Oncology, demonstrates 100% concordance between Aspyre Lung and NGS, with 100% sensitivity and specificity even at low tumor content. The limit of detection was determined to be <3% variant allele fraction for DNA variants, and <100 copies for RNA fusions. The results were highly reproducible across operators, reagent lots, runs and real-time PCR instruments with a high degree of precision.
Evaluation of the Aspyre Lung Targeted Variant Panel: A rapid, low-input solution for NSCLC biomarker testing and experience from three independent sites published in Translational Lung Cancer Research demonstrates that Aspyre Lung Reagents can be easily set up and run at external laboratories within a few days, producing reliable results even from challenging sample types. Nucleic acid derived from 77 clinical samples was tested across three sites including Biofidelity, the Hospital of the University of Pennsylvania and the Precision Medicine Laboratory at the Medical College of Wisconsin. The samples included FFPE tissue, peritoneal and pleural effusions , fine needle aspirates (FNA), FNA rinses, and fresh tissue. The results were then compared between sites and to orthogonal next generation sequencing-based methods.
Further Reading
Evaluating Aspyre Lung Study Results
A comparison of Aspyre Lung results across the three sites gave 100% positive percent agreement (PPA) and 99.99% negative percent agreement (NPA). Further, a comparison of Aspyre Lung results to NGS results gave a PPA of 96.2% and NPA 99.97%. Aspyre Lung consistently yielded results from challenging cytology samples, with 100% PPA and 99.93% NPA.
The data also highlight that the sensitivity of Aspyre Lung enables the detection of variants that may be missed using current approaches, which has significant implications in both the clinical and research settings. Biofidelity identified a ROS1 gene fusion in one sample across three different sites which was not detected by NGS. Subsequent retesting using another orthogonal method gave a result in agreement with Aspyre Lung, indicating a false-negative with the original orthogonal method.
