Summary: Aces Diagnostics and Focus on Lyme have announced LymeSeek, a new diagnostic test for Lyme disease, capable of detecting the disease at all stages, including within 14 days of infection, with over 90% accuracy, aiming for FDA approval.
Takeaways:
- LymeSeek improves early-stage detection of Lyme disease, surpassing current tests’ accuracy of less than 50%.
- The test uses advanced biomarkers and machine learning to provide faster, more reliable diagnoses.
- Aces Diagnostics is pursuing FDA clearance, with plans to make the test widely available by late 2026.
Focus on Lyme and Aces Diagnostics Inc. announced a breakthrough in Lyme disease diagnosis with a new test that detects the disease at all stages, including the crucial first 14 days post-infection, with over 90% accuracy. Aces Diagnostics is developing and manufacturing this test, aiming for FDA clearance to make it accessible to all patients.
The New LymeSeek Diagnostic Test
LymeSeek, developed through a collaboration between Tulane University and Focus on Lyme, combines advanced biomarker research from Tulane’s Monica Embers and nine years of intensive work funded by Focus on Lyme. Enhanced by machine learning, this innovative diagnostic promises to reshape Lyme disease detection.
“Previous tests have been less than 50% accurate, especially in the early stages,” says Tammy Crawford, CEO of Aces Diagnostics. “This has led to countless patients being misdiagnosed or undiagnosed, resulting in prolonged suffering. LymeSeek will change that, providing a reliable diagnostic tool that can save lives.”
Impact of Lyme Disease
The CDC reports that nearly 500,000 people in the U.S. are diagnosed with Lyme disease each year. Globally, 14.5% of the population is affected, with many suffering from chronic symptoms due to delayed diagnosis. A Johns Hopkins study revealed that 38% of Lyme patients continue to experience symptoms six months post-diagnosis, underscoring the need for improved testing.
“Current Lyme testing involves multiple steps, with results taking over a week and requiring subjective interpretation,” says Aces Diagnostics Co-Founder Holly Ahern. “LymeSeek will replace this cumbersome process, enabling earlier diagnosis and reducing chronic illness caused by delayed or missed diagnoses.”
Crawford and Ahern are personally invested in this mission, both having daughters who battled Lyme disease.
“An early diagnosis could have spared them years of suffering,” says Crawford.
Aces Diagnostics Inc. brings together a team with over 50 years of combined experience in Lyme disease research, backed by a distinguished advisory board that includes experts from Johns Hopkins University, Columbia University, and Tulane University. The company is already advancing development and manufacturing efforts and pursuing early FDA clearance to make LymeSeek available to the public by the third quarter of 2026.
Further reading: Lyme Disease ImmunoBlot Test Gets FDA Clearance
