En Carta Diagnostics Receives FDA Breakthrough Device Designation for Revolutionary Lyme Disease Test
Key Insights
En Carta Diagnostics (search) received FDA Breakthrough Device Designation for EC Pocket Lyme (search), a molecular diagnostic test that detects Borrelia bacteria (search) directly from skin samples at tick bite sites.
The test addresses critical gaps in early Lyme disease (search) detection by using DNA identification before immune response appears, unlike current antibody tests that require 5-6 weeks.
With 476,000 new Lyme disease (search) cases annually in the US and increasing prevalence over 40 years, the portable test could serve 50 million people who experience tick bites yearly.
En Carta Diagnostics (search), a Paris-based deeptech startup, has received FDA Breakthrough Device Designation for EC Pocket Lyme (search), a revolutionary molecular diagnostic test designed to detect Lyme disease (search)-causing bacteria directly from skin samples. The designation marks a significant milestone for addressing one of the most challenging infectious diseases to diagnose at early stages.
Addressing Critical Diagnostic Gap
EC Pocket Lyme (search) represents a paradigm shift in Lyme disease (search) detection by targeting Borrelia bacteria (search) directly from skin interstitial fluid samples obtained from individuals with signs of tick bites or erythema migrans (search) (EM). The molecular assay delivers visual results through a single-use cassette format designed for accuracy, affordability, and accessibility.
Current standard-of-care relies on visual diagnosis of erythema migrans (search) rash and antibody detection tests. However, these approaches have significant limitations: EM can go unnoticed, and antibodies become detectable only five to six weeks after a tick bite, rendering early-stage immuno-based testing impossible. If left undiagnosed or untreated early, Lyme disease (search) can develop into acute illness and in rare cases can result in death.
Innovative Technology Platform
The EC Pocket Lyme (search) platform addresses these limitations through two key innovations. First, its microneedle-based sampler allows access to interstitial fluid directly at the tick bite site, unlocking a sample source previously inaccessible without invasive biopsy. Second, the portable molecular test accurately detects Lyme disease (search)-causing bacteria via DNA identification before the immune response appears.
The technology leverages aptamer-based technology developed through more than a decade of intensive research, enabling high-affinity and high-specificity binding to predefined targets. These molecular signatures can be programmed to detect a wide range of genetic, pathogenic, and veterinary indications, opening possibilities for a broad pipeline of future applications beyond Lyme disease (search).
Significant Market Impact
The global prevalence of Lyme disease (search) is most widespread in the Northern Hemisphere, with cases steadily increasing for over 40 years. The US sees an estimated 476,000 new cases of Lyme disease annually. The diagnostic platform could potentially serve the 50 million people who experience signs of tick bites each year.
"From an investment perspective, this milestone de-risks our development program and enhances our credibility with regulators and partners. If approved, our diagnostics platform will be the first one to aid in the early detection of the bacteria responsible for Lyme disease (search)," said Guillaume Horreard, co-founder and CEO of En Carta Diagnostics (search).
Regulatory Advantages
FDA Breakthrough Device Designation is reserved for technologies demonstrating potential to provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. Through this designation, the FDA will provide En Carta Diagnostics (search) with priority review and enhanced, interactive communication with FDA experts and senior leadership, supporting a more efficient path toward US commercialization.
"This Breakthrough Device Designation is a pivotal moment for us. It significantly strengthens our regulatory path by enabling closer collaboration with the FDA and accelerating our route to market, so patients can benefit from our technology sooner. The designation is also a powerful external validation of the quality, robustness and clinical relevance of our platform," said Dr. Margot Karlikow, co-founder and CTO of En Carta Diagnostics (search).
Company Background
Founded in 2022 by Harvard and Institut Pasteur alumni, En Carta Diagnostics (search) has built five prototypes and published ten papers in scientific journals demonstrating proof of concept on pathogens including Zika, chikungunya, Ebola, and typhoid. The company secured a commercial contract with a digital healthcare leader and raised €1.5M in 2024, reaching clinical stage prior to receiving FDA breakthrough designation.
The scientific team received a $17.7M DARPA project award in 2023 and collaborates with an extensive network of research institutes in Latin America. The company is a Creative Destruction Lab graduate, incubated at Paris Biotech Santé and 50 Partners Santé.