Epicore Biosystems is collaborating with the Middle East Cystic Fibrosis Association to advance a next-generation wearable microfluidic device platform for the monitoring and ongoing management of cystic fibrosis, the company said. The company said the collaboration pairs its on-body sweat induction and sensing technology with MECFA's work to expand access to cystic fibrosis care across the Middle East, North Africa and Central Asia, and is aimed at widening access to sweat chloride monitoring in the Middle East and other underserved regions.
Sweat chloride concentration is the gold-standard biomarker for diagnosing cystic fibrosis and, increasingly, for monitoring how well a patient responds to CFTR modulator therapy, according to the company. The measurement itself, it said, has not fundamentally changed in decades: a technician stimulates sweat production using pilocarpine iontophoresis, the sweat is collected in a separate device and the sample is sent to a laboratory. Epicore's device in development, the Chloride Tracker, combines sweat induction and chloride sensing in a single wearable sensor and mobile application, capturing and analysing sweat in real time without off-body laboratory analysis. The company said the technology has been clinically tested across multiple cystic fibrosis studies, with results published in Nature Digital Medicine and Science Translational Medicine.
The company said the need for a simple, low-cost system is especially acute across the Middle East and other low- and middle-income regions, where newborn screening for cystic fibrosis remains rare and specialised diagnostic infrastructure is scarce. It said Türkiye is currently the only country in the region operating a national newborn screening programme. Clinical testing of the Chloride Tracker in the region will be led by Marmara University in Istanbul, which the company described as home to the largest cystic fibrosis centre in Europe.
MECFA's president and chief executive, Christine Noke, said families navigating the disease deserve access to testing that is fast and accurate and does not require a specialised clinic visit, a need she described as especially urgent in the communities MECFA serves. Prof. Dr. Bülent Karadağ, director of the Marmara University Cystic Fibrosis Centre and a MECFA vice president, said a device that can confirm and track the disease without a laboratory would let physicians across the region monitor children early enough to change the course of their lives.
The collaboration is focused on expanding access across MECFA member countries and other comparable low- and middle-income settings. The company said development of the platform for clinical trial endpoints and post-therapy monitoring in the United States and European markets is continuing in parallel, supported by its internal research and development and global partnerships.
