En Carta Diagnostics has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation (BDD) for EC Pocket Lyme, its test for the early detection of Lyme disease-causing bacteria.
 
As a molecular assay with a visual result, EC Pocket Lyme can detect Borrelia bacteria directly from skin interstitial fluid samples from individuals with signs of tick bites or erythema migrans (EM). The test is delivered in a single-use frugal cassette format designed for accuracy, affordability, and accessibility, allowing easy large-scale distribution. The results will aid in the diagnosis of infections with Borrelia bacteria causing Lyme disease, in conjunction with clinical findings and other laboratory tests.
 
FDA Breakthrough Device Designation is reserved for technologies that have demonstrated the 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 with a 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,” En Carta Diagnostics Co-Founder/Chief Technology Officer Dr. Margot Karlikow stated. 
 
A tick-borne infection, Lyme diseases is one of the most challenging infectious diseases to diagnose at an early stage. Existing care standards rely on visual diagnosis of a specific rash (erythema migrans or EM) and tests detecting the antibodies produced by the immune system in response to infection. However, 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 not treated early, Lyme disease can develop into an acute illness and, in rare cases, can result in death.
 
EC Pocket Lyme is set to address this limitation with two solutions. First, its microneedle-based sampler, which allows access to interstitial fluid right at the tick bite—thus unlocking a sample source previously inaccessible without an invasive biopsy. Second, its portable and precise molecular test designed to accurately detect Lyme disease-causing bacteria via DNA identification, before the immune response appears. People showing signs of a tick bite or a suspected EM will be able to rapidly determine whether they are at risk of Lyme disease.
 
The global prevalence of Lyme disease is most widespread in the Northern Hemisphere, and the number of cases has been steadily increasing for more than 40 years. There are an estimated 476,000 new cases of Lyme disease in the US, annually.
  
The EC Pocket Lyme platform is underpinned by more than a decade of intensive research and leverages aptamer-based technology, which enables high-affinity and high-specificity binding to predefined targets, according to the company. These molecular ‘signatures’ can be programmed to detect a wide range of genetic, pathogenic, and veterinary indications, opening the door to a broad pipeline of future applications beyond Lyme disease.
 
“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. I am convinced our work will become a go-to solution for the 50 million people who see signs of a tick bite each year. I am immensely proud of our team, who transformed, in record time, frontier synbio technology into a robust and cost-effective product,” En Carta Diagnostics Co-Founder/CEO Guillaume Horreard said.
 
En Carta Diagnostics is a deep-tech startup creating point-of-need molecular diagnostics that are as easy to use as rapid tests, with the precision of a PCR machine. Its first product focuses on the early diagnosis of Lyme disease, a growing health challenge in the United States and Europe with no effective solution currently on the market.

The company develops a patented molecular diagnostics platform with an exclusive worldwide license. Founded in 2022 by Harvard and Institut Pasteur alumni, En Carta Diagnostics has built five prototypes, published 10 papers in scientific journals on the proof of concept on pathogens including Zika, chikungunya, Ebola, and typhoid, and secured a commercial contract with a digital healthcare leader.
Its scientific team members received a $17.7 million DARPA project award in 2023 and collaborate with an extensive network of research institutes in Latin America. The company also raised €1.5 million in 2024 and reached the clinical stage before receiving FDA breakthrough designation. Located in Paris, En Carta Diagnostics is a Creative Destruction Lab (CDL) graduate, incubated at Paris Biotech Santé and 50 Partners Santé.