January 2025—Biofidelity announced the publication of data that highlight how Aspyre technology addresses the need for rapid, accessible molecular diagnostics informing actionable genomic variants in cancer (Herlihy SE, et al. Transl Lung Cancer Res. 2024;13[11]:3083–3095). The study 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. The samples included FFPE tissue, peritoneal and pleural effusions, fine needle aspirates, fine needle rinses, and fresh tissue. A comparison of results across the three sites gave 100 percent positive percent agreement and 99.99 percent negative percent agreement. A comparison to next-generation sequencing results gave a PPA of 96.2 percent and an NPA of 99.97 percent.
The data also highlight that the sensitivity of Aspyre Lung enables the detection of variants that may be missed using current approaches. Biofidelity identified a ROS1 gene fusion in one sample that 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.
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