Aces Diagnostics Announces Key Development Partnerships for Novel LymeSeek™ Test

PHOENIX, Dec. 16, 2025 /PRNewswire/ -- Aces Diagnostics Inc., a biotechnology company dedicated to delivering accurate and accessible diagnostics for Lyme disease, announced significant progress toward commercialization of its flagship LymeSeek™ test through new development partnerships with Protavio and Repado.

LymeSeek is an innovative, single-blood-draw diagnostic that uses a multiplexed immunoassay and proprietary machine-learning algorithm to achieve more than 90% accuracy across all stages of Lyme disease, including the earliest weeks of infection. This represents a significant advance over current standard-of-care testing, which often fails to detect early-stage cases. LymeSeek is moving through final product development ahead of clinical validation, regulatory submission, and review by the U.S. Food and Drug Administration.

Lyme disease is a high-incidence infectious disease with a global prevalence estimated at 14.5% of the world's population. In the United States alone, the Centers for Disease Control and Prevention (CDC) reports approximately 476,000 diagnosed cases each year, making Lyme disease one of the three most frequently diagnosed infectious diseases nationwide.

To support FDA and ISO 13485 requirements, Aces Diagnostics has partnered with global leaders to advance LymeSeek's core components. Protavio, a multiplex proteomics company based in Athens, Greece, is leading the development of the IVD-grade test kit, ensuring the immunoassay's design and manufacturing meet stringent regulatory and quality standards.

Repado, an ISO 13485-certified software firm specializing in life science and healthcare, is developing the LymeSeek Analysis software. The platform incorporates Aces Diagnostics' machine-learning algorithm and generates the final diagnostic report, supporting accuracy, objectivity, and regulatory compliance.

"The development of LymeSeek is a mission-driven effort for our entire team, and these strategic partnerships are instrumental to its success," said Tammy Crawford, CEO of Aces Diagnostics Inc. "Protavio's excellence in assay development and manufacturing, combined with Repado's cutting-edge software development for our machine-learning algorithm, ensures we're building a robust, high-quality, scalable diagnostic solution. LymeSeek will move the needle for patients, giving doctors an accurate tool to diagnose Lyme disease earlier, when it's most treatable, and reducing the risk of long-term complications."

With combined strengths in biomarker research, precision manufacturing, and regulatory-compliant medical software, Aces Diagnostics and its partners aim to bring forward the first clinically accurate in-vitro diagnostic capable of detecting all stages of Lyme disease. LymeSeek represents the culmination of years of research and collaboration and seeks to close the diagnostic gap that leaves hundreds of thousands of patients without early answers each year.

To learn more about Aces Diagnostics' work to revolutionize Lyme disease testing, visit acesdiagnostics.com.

Media Contact:
Ashlee Singleton
480-695-2039
[email protected] 

SOURCE Aces Diagnostics