Closely held En Carta Diagnostics has announced that its EC Pocket Lyme test for the early detection of Borrelia bacteria—the cause of Lyme disease—has received Breakthrough Design Designation (BDD) from the FDA.
EC Pocket Lyme is a molecular assay with a visual result, intended to 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, enabling easy large-scale distribution. Results are intended to aid in the diagnosis of Borrelia infections causing Lyme disease, in conjunction with clinical findings and other laboratory tests.
In a statement, Dr. Margot Karlikow, co-founder and CTO of En Carta, commented, “This BDD 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.”
Lyme disease is a tick-borne infection and remains one of the most challenging infectious diseases to diagnose at an early stage. Existing standard-of-care relies on visual diagnosis of a characteristic rash—EM—and tests that detect antibodies produced by the immune system in response to infection. However, EM can go unnoticed, and antibodies typically become detectable only five to six weeks after a tick bite, rendering early-stage immuno-based testing ineffective. If left undiagnosed or untreated early, Lyme disease can progress to acute illness and, in rare cases, result in death.
EC Pocket Lyme is set to address this limitation with two innovations. First, its microneedle-based sampler enables access to interstitial fluid right at the tick bite site, unlocking a sample source previously inaccessible without an invasive biopsy. Second, its portable and precise molecular test accurately detects Lyme disease-causing bacteria via DNA identification before the immune response appears. Individuals showing signs of a tick bite or a suspected EM will be able to rapidly assess their risk of Lyme disease.
Lyme disease is most prevalent in the Northern Hemisphere, and case numbers have been steadily increasing for more than 40 years. An estimated 476,000 new cases of Lyme disease occur annually in the U.S.
