AI-Powered Lyme Disease Diagnostic Test Debuts at ADLM 2025

Lyme disease is the most common vector-borne illness in the U.S., with an estimated 476,000 cases annually, though cases are likely underreported, according to the CDC. Though most prevalent in the Northeast, mid-Atlantic, and upper Midwest, cases have been reported in all 50 states and over 80 countries worldwide. Current Lyme disease diagnostics are complex. A new Lyme diagnostic test, utilizing artificial intelligence (AI) to enhance performance, has been introduced at this year’s ADLM Conference.

InBios International (Seattle, WA, USA) is developing the Lyme Detect Multiplex ELISA, an innovative array-based immunoassay in a traditional ELISA plate format that incorporates an automated software package to analyze, quantify, and, using machine learning interpretations, classify specimens. This novel approach is designed to significantly enhance workflow and acute-stage sensitivity for the diagnosis of Lyme disease.

InBios’ test advances beyond the standard two-tiered testing (STTT) and modified two-tiered testing (MTTT) for Lyme disease by combining IgG and IgM antibody detection in a single immunoassay. It simultaneously quantifies responses to a broad panel of B. burgdorferi antigens and utilizes machine-learning-guided analysis to determine the status of the clinical specimen, providing results in under two hours. Leveraging microarrays, machine learning, and automated interpretation, InBios’ assay significantly expands the amount and quality of data analyzed.

Pre-clinical and in-house performance testing compared InBios’ assay to the STTT and MTTT algorithms. Initial testing with blinded specimens indicated a statistically significant 30-40% sensitivity improvement for detecting early Lyme erythema migrans specimens when compared to STTT and a 15% improvement compared to MTTT, without compromising specificity. Minimal to no cross-reactivity was observed, even in problematic samples, including those positive for rheumatoid factor, syphilis, and fibromyalgia. The test debuted at ADLM 2025, where James Needham, PhD, InBios’ Director of Product Development, gave a talk titled “AI-Powered Lyme Diagnostics: The Future is Multiplexed” about the new diagnostic.

“InBios' new test simplifies the process, offering faster, more informative results compared to the traditional two-tier method,” said Needham. “It streamlines workflow by eliminating the need for sequential testing, which should result in faster turnaround times and reduced cost per patient.”

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InBios International