A-380 Maverick: Revolutionizing Immunoassay Testing with Photonic Ring Resonance Technology for Faster, More Accurate Results

Abstract Background Immunoassays have been the backbone of clinical diagnostics for decades, but current technologies—such as luminescence-based assays—have remained largely unchanged for over 40 years. These methods often require multiple steps, take longer to deliver results, and can suffer from higher variability. Genalyte*s Maverick works on label-free silicon chips with photonic ring resonance technology to miniaturize immunoassay testing. This breakthrough technology enables faster, more accurate, and more precise testing of analytes in under 30 minutes and opens the door for customized assays at the point of care. Methods The performance of the Maverick device was evaluated through method comparison studies for TSH (FDA-approved in July 2024) and hsCRP (under development). Both analytes were tested using the same predicate device: Beckman Coulter Unicel DxI 800, Access Immunoassay System. A total of 131 whole blood samples were tested for each analyte using Maverick and the predicate system. Deming regression analysis assessed method equivalency with slope, correlation coefficient (R²), and percent mean difference calculated for each analyte. Precision studies were also conducted to evaluate repeatability and site-to-site reproducibility across multiple external sites. Results Maverick demonstrated exceptional accuracy, with strong correlation (R² = 0.96) and slope values near 1.0 for both TSH and hsCRP. TSH: Slope 0.96 (95% CI: 0.93 - 0.99), R2 = 0.96 hsCRP: Slope 1.0 (95% CI: 0.98–1.0), R2 = 0.99 Percent mean differences for both analytes were within acceptable limits (-7.3% to -4.5% for TSH and -6.9% to -3.8% for hsCRP). Precision studies confirmed acceptable repeatability with CVs = 5%. Conclusion The Maverick silicon photonics platform offers a breakthrough in immunoassay diagnostics, providing fast, accurate, and precise results in under 30 minutes. Leveraging photonic ring resonance technology, Maverick eliminates the need for complex immunoassay labels and enables testing at the point of care. With FDA clearance for TSH, and RNP and the potential for custom assays, Maverick is positioned to modernize immunoassay testing, offering a more efficient, cost-effective, and reliable alternative to traditional methods.