En Carta Diagnostics, a Paris-based start-up developing rapid point-of-need molecular diagnostics kits, has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its EC Pocket Lyme.
As a molecular assay with a visual result, EC Pocket Lyme is intended for the detection of Borrelia bacteria - the cause of Lyme disease - 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 commercialisation.
“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.
Lyme disease, a tick-borne infection, remains one of the most challenging infectious diseases to diagnose at an early stage. Existing standard-of-care relies on visual diagnosis of a specific type of 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 acute illness and in rare cases can result in death.
EC Pocket Lyme is set to address this limitation with two innovative solutions. First, its microneedle-based sampler, that allows access to interstitial fluid right at the tick bite - 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 over 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. 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.