En Carta Diagnostics, a start-up company developing molecular diagnostics kits, has announced that its EC Pocket Lyme test has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).
The goal of EC Pocket Lyme is to detect Borrelia bacteria in interstitial fluid samples taken from the skin of people with signs of tick bites or erythema migrans (EM). It has been designed with affordability and accessibility in mind, being delivered in a single-use cassette format that can be widely distributed. Results from EC Pocket Lyme can be combined with other tests and clinical findings to assist with the diagnosis of the Borrelia infections that cause Lyme disease.
Lyme disease is an infection transmitted through tick bites. It is difficult to diagnose at an early stage, with current diagnostics including observation of the disease’s visual symptoms and antibody detection tests. There is an unmet medical need for better Lyme diagnostic tests, since, if not treated early, Lyme can cause serious illness and even death.
The FDA grants Breakthrough Device Designation to products that can help with the diagnosis or treatment of very serious diseases. The FDA will now give priority review to EC Pocket Lyme, as well as giving En Carta increased communication with experts.
Cases of Lyme have been increasing for more than four decades. The US sees around 476,000 new Lyme cases every year.
Dr Margot Karlikow, co-founder and chief technology officer of En Carta, said: “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 [sooner].”
