Key Investor Signals
EC Pocket Lyme received FDA Breakthrough Device Designation.
The FDA granted Breakthrough Device Designation to EC Pocket Lyme, En Carta's rapid molecular test for detecting Borrelia bacteria in skin interstitial fluid near a tick bite.
Raised €1.5M in early financing led by CentraleSupélec Venture.
En Carta Diagnostics raised €1.5 million in May 2024, led by Venture, to advance its Lyme diagnostic platform and prepare industrial scale-up.
AAZ-LMB commercialization partnership
partnered with En Carta to co-develop and commercialize rapid molecular tests and self-tests for and screening in Europe.
Other Positive Signals
- Holds an exclusive worldwide license to its patented platform.
- Launched a clinical study of microneedle-based sampling for early Lyme detection.
- Reported 98.5% diagnostic accuracy for across 268 patient samples.
- Built five prototypes and published around ten proof-of-concept papers across multiple .
- Scientific team members received a $17.7M in 2023.
Team
Margot Karlikow, PhD
Co-founder
- 5 years as a postdoctoral researcher at the University of Toronto’s Pardee Lab, focused on low-cost diagnostics.
- Led field validation of portable Zika and diagnostics on real patient samples in Latin America, published in Nature Biomedical Engineering.
- Demonstrated 98.5% diagnostic accuracy for Zika testing on 268 patient samples, showing direct experience taking diagnostics beyond the lab.
- 6 years as a PhD student at Institut Pasteur’s Viruses and RNA Interference team, building deep expertise in viral infection biology.
Guillaume Horreard
Co-founder
- Former Product Manager at XE.com, working on a global platform with 218M unique visitors and USD 10B+ in transfers.
- 5+ years managing complex product projects across smart-grid and IT systems, combining energy infrastructure, software, cybersecurity, and cloud computing.
- Former Technical Product Manager at ENEDIS / ERDF, leading SEQUOIA from POC to industrial deployment across 30 sites.
- Engineering graduate from CentraleSupélec / École Centrale Paris, one of France’s top engineering schools.
Product
En Carta Diagnostics is developing EC Pocket Lyme, a portable molecular test for early Lyme disease. The test is designed to detect Borrelia bacteria directly from skin interstitial fluid collected near a tick bite or erythema migrans rash.
Local skin-fluid sampling
A microneedle-based sampler collects interstitial fluid from the skin near the suspected infection site. This targets the area where Borrelia bacteria may be present during early infection.
Direct bacterial detection
EC Pocket Lyme is designed to detect Borrelia rather than antibodies produced by the patient. This could allow testing before the immune response becomes detectable through standard serology.
Single-use point-of-need format
The molecular assay is being developed in a portable, single-use that does not depend on centralized laboratory infrastructure. The format is intended for near-patient settings such as and pharmacies.
Market Overview
Lyme disease creates a large diagnostic burden across the United States and Europe. Around 476,000 people are estimated to be diagnosed and treated annually in the US, while approximately 132,000 cases are reported each year in Europe. The potential testing population is larger because millions of people experience tick bites without knowing whether they have been infected.
The main gap occurs during early infection. Standard tests detect antibodies produced by the immune system, which may remain undetectable for several weeks after infection. This creates demand for molecular tests that detect the pathogen directly and can be used closer to the patient.
Estimated number of people diagnosed and treated for Lyme disease each year in the United States.
Estimated number of people bitten by ticks each year in the United States.
Sensitivity of standard two-tier antibody testing during early Lyme infection.
Projected global market growth from 2025 to 2030, representing a 10.5% compound annual growth rate.
Comparable Outcomes
T2 Biosystems / T2Lyme
developed molecular diagnostic systems for rapid pathogen detection, including , a direct-from-blood test designed to detect Lyme disease-causing Borrelia bacteria in early-stage patients. The company went public on Nasdaq in 2014. Based on the IPO price and shares outstanding after the offering, the transaction implied an IPO valuation of approximately $326 million.
Mesa Biotech / Accula
developed , a rapid for infectious disease testing. The system was designed to bring molecular testing closer to patients in settings such as physician offices, pharmacies, and near-patient care environments. acquired Mesa Biotech for approximately $450 million in cash, with up to $100 million in additional milestone payments. Mesa had generated approximately $45 million in 2020 revenue before the acquisition.
Cepheid / GeneXpert
built , a fully automated molecular diagnostics platform designed to deliver rapid genetic testing for infectious diseases and other clinical applications. Its model combined instruments, cartridges, and a broad test menu across decentralized and laboratory settings. Danaher acquired Cepheid for approximately $4.0 billion in enterprise value. Cepheid had generated a revenue of $539 million in 2015.
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Sources
This profile was built from public company materials, ecosystem sources, market references, and professional profiles.