Single-Tier Lyme Disease Test Shows High Sensitivity in Early Infection

Lyme disease can be difficult to diagnose during the earliest stages of infection, when conventional serologic testing may have limited sensitivity. Patients may present during a diagnostic gray zone in which standard two-tier serology does not yet identify infection. To improve detection during this early window, a new single-tier diagnostic test analyzes antibody responses to Borrelia burgdorferi antigens.

LymeSeek, developed by ACES Diagnostics and research collaborators, is being evaluated as a single-tier Lyme disease diagnostic test. The assay is a multiplex bead-based flow immunoassay designed to detect immunoglobulin M and immunoglobulin G antibody responses to eight Borrelia burgdorferi antigens. A proprietary machine learning-developed algorithm analyzes antibody-binding patterns and provides a single “detected” or “not detected” result.

The peer-reviewed study, published in the Journal of Clinical Microbiology on October 5, evaluated LymeSeek in several sample cohorts. In an initial 467-sample training and validation cohort, the test achieved 90% sensitivity and 93% specificity across disease stages. In a separate evaluation of 50 patients with early Lyme disease, LymeSeek identified 100% of cases within 15–30 days of illness onset and 90% within two weeks.

The study also assessed 30 clinically diagnosed Lyme disease cases that tested negative with standard two-tier serology. LymeSeek detected 70% of cases among patients with erythema migrans and 60% of cases among patients with symptoms consistent with early Lyme disease but without erythema migrans. In a preliminary reproducibility assessment following transfer from Tulane University to the manufacturing environment at Protavio Ltd. in Greece, the test achieved 90% sensitivity and 98% specificity in a separate cohort of more than 250 individuals.

ACES Diagnostics is preparing to begin clinical trials of LymeSeek at three laboratory sites in October 2026. The company has initiated the FDA 510(k) pathway and is targeting market availability in early Q2 2027, pending regulatory clearance.

“Early diagnosis remains one of the most important challenges in Lyme disease because the tests clinicians rely on today can have limited sensitivity during the first weeks of infection. These findings demonstrate the potential of LymeSeek to provide clinicians with meaningful diagnostic information during precisely that period of uncertainty,” said Tammy Crawford, Founder & CEO, ACES Diagnostics.

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