En Carta Diagnostics received FDA Breakthrough Device Designation for EC Pocket Lyme, a rapid molecular point‑of‑care assay that detects Borrelia DNA from skin interstitial fluid using a microneedle sampler and isothermal amplification. The designation enables closer agency interaction and an accelerated regulatory pathway for commercialization. En Carta said its platform leverages aptamer-based target capture and loop-mediated isothermal amplification to deliver high-affinity detection in a single‑use cassette designed for decentralised testing. Company executives noted the designation de‑risks the program from a regulatory and investment standpoint and could enable earlier access in endemic regions. If approved, the device would be the first POC molecular Lyme test intended for early detection at the site of tick bites, with potential to expand the platform to other infectious and veterinary targets.