En Carta Diagnostics has announced that its test for the early detection of Borrelia bacteria (the cause of Lyme disease) has received Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA).
The EC Pocket Lyme is a molecular assay with a visual result and is intended for the detection of 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.
Through the FDA Breakthrough Device 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.
Why this matters
Lyme disease, a tick-borne infection, remains one of the most challenging infectious diseases to diagnose at an early stage.
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.
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.
New way of delivering fast and accurate Point-of-Need diagnostics
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.
"From an investment perspective, this milestone de-risks our development programme 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,” said Guillaume Horreard, co-founder and CEO of En Carta Diagnostics.