ACES Diagnostics Research Demonstrates Potential of LymeSeek™ to Improve Detection of Early Lyme Disease

A peer-reviewed study in the Journal of Clinical Microbiology reports more than 90% sensitivity across disease stages and improved detection in the early diagnostic "gray zone."

PHOENIX, Oct. 6, 2026 /PRNewswire/ -- A new peer-reviewed study published in the Journal of Clinical Microbiology demonstrates the potential of LymeSeek™, a single-tier Lyme disease diagnostic test developed by ACES Diagnostics and its research collaborators, to improve detection of Lyme disease during the earliest stages of infection, when conventional serologic testing can have limited sensitivity.

The study, "Multiplex single-tier LymeSeek™ test improves sensitivity during the diagnostic gray zone of early Lyme disease," evaluated LymeSeek™, a multiplex bead-based flow immunoassay designed to detect IgM and IgG antibody responses to a novel combination of eight Borrelia burgdorferi antigens. A proprietary machine learning-developed algorithm analyzes patterns of antibody binding to provide a single "detected" or "not detected" result.

In an initial 467-sample training and validation cohort, LymeSeek™ achieved 90% sensitivity and 93% specificity across disease stages. In a separate evaluation of 50 patients with early Lyme disease, the test identified 100% of cases within 15–30 days of illness onset and 90% within two weeks.

The study also examined 30 clinically diagnosed Lyme disease cases that tested negative using standard two-tier serology. LymeSeek™ detected 70% of cases among patients presenting with erythema migrans (EM) and 60% of cases among patients with symptoms consistent with early Lyme disease but without EM, providing additional evidence of the test's potential in cases where conventional testing may not identify infection.

"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," said Tammy Crawford, Founder & CEO, ACES Diagnostics. "These findings demonstrate the potential of LymeSeek™ to provide clinicians with meaningful diagnostic information during precisely that period of uncertainty."

The research included a preliminary reproducibility assessment after transferring the LymeSeek™ assay from its original academic research environment at Tulane University to the manufacturing environment at Protavio Ltd. in Greece. In a separate cohort of more than 250 individuals, LymeSeek™ achieved 90% sensitivity and 98% specificity, with performance remaining consistent following technology transfer.

"These results reinforce the scientific foundation behind our approach to Lyme disease diagnostics," said study co-author Holly Ahern, Chief Scientific Officer, ACES Diagnostics. "Our goal is to help close the diagnostic gap that exists during early infection and ultimately give healthcare providers a more sensitive tool to support clinical decision-making."

ACES Diagnostics' development of LymeSeek™ is supported by Bay Area Lyme Ventures, the venture philanthropy initiative of Bay Area Lyme Foundation focused on accelerating promising innovations in Lyme disease diagnostics, therapeutics, and digital health technologies. Bay Area Lyme Ventures has supported ACES Diagnostics as part of its mission to advance promising innovations from research to clinical development and commercialization.

The Lyme Disease Biobank, a program of Bay Area Lyme Foundation, has contributed to this study and the broader research ecosystem supporting advances in Lyme disease research. With specimens from more than 1,250 participants, the Biobank provides biological samples to approved researchers working to better understand Lyme disease and develop improved diagnostics and therapeutics.

"For more than a decade, Bay Area Lyme Foundation has invested in the research and innovation needed to address significant gaps in Lyme disease diagnosis and treatment," said study co-author Liz Horn, PhD, MBI, Principal Investigator, Lyme Disease Biobank. "These results from ACES Diagnostics and LymeSeek are encouraging and demonstrate the potential for innovative diagnostic approaches to help address the challenges of detecting Lyme disease early."

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

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SOURCE Aces Diagnostics