En Carta Diagnostics is preparing to launch an at-home Lyme disease molecular test using an aptamer sensor coupled with isothermal amplification and a cartridge-based workflow. The company says it received a breakthrough device designation for the test earlier this year, secured €5 million ($5.7 million) in private financing, and is exchanging with the FDA through the Q-submission program. The plan targets regulatory certification in the EU, with a clinical trial funded by the financing intended to support market authorization. En Carta’s approach uses a microneedle patch to sample skin interstitial fluid from the bite site, followed by loop-mediated isothermal amplification and a DNA aptamer “flip open” readout concept. The company also plans to sell a reader device alongside the cartridges. If the test reaches authorization, it would expand molecular diagnostics beyond lab settings and add a new entrant model for low-cost home sampling—an area that will be closely watched by clinical and payer stakeholders.