Lucid Diagnostics is getting ahead of the supply chain curve by partnering with Coastline International, a high-volume manufacturer.

The company said Coastline International will manufacture its EsoCheck devices.

EsoCheck is commercialized in the U.S. as a 510(k)-cleared esophageal cell collection device. EsoGuard, used with EsoCheck, a laboratory developed test, was granted FDA Breakthrough Device designation and is the subject of multiple ongoing clinical trials.

Lucid is building nationwide direct sales and marketing teams targeting primary care physicians, specialists, and institutions, as well as a network of Lucid Test Centers, where at-risk GERD patients can undergo the EsoCheck procedure for EsoGuard testing.

“The successful transition of EsoCheck production to a high-volume manufacturer reflects our deep commitment to drive efficiencies throughout the entire commercialization cycle,” said Lishan Aklog, M.D., Lucid’s Chairman and CEO. “This transition will reduce the per-unit manufacturing cost of EsoCheck devices by about 60% and provide scalable manufacturing capacity to accommodate accelerating growth in EsoGuard Esophageal DNA Test testing volume. Following this transition, EsoCheck manufacturing capacity is now approximately 20,000 units per year. The system has been designed to allow capacity to be scaled to over one million units per year by adding additional manufacturing lines as demand dictates.”

Lucid was spun out from PavMed in February of 2021. Aklog was a guest on Episode 29 of Let’s Talk Medtech and spoke about the firm’s goals. You can access that episode below.