Perspectum, a medical imaging technology company, has received a substantial research grant from the U.S. Food and Drug Administration (FDA). The nearly $250,000 grant, awarded under the Drug Development Tool (DDT) Research Grant program, will support the investigation of a novel biomarker for rare diseases. This research, conducted in collaboration with the Consortium for Autoimmune Liver Disease (CALiD), focuses on primary sclerosing cholangitis (PSC), a rare but serious liver disease affecting over 36,000 people in the U.S. PSC is the fourth leading cause of liver transplants, underscoring the critical need for effective treatments.
The biomarker under investigation has shown promise in preliminary research and could significantly improve the monitoring and treatment of PSC and other rare diseases. The research will leverage CALiD’s extensive database, one of the largest for PSC in North America. The study will involve at least 150 patients with serial MRCP+ reports, analyzing the correlation between changes in the biomarker and clinical outcomes. A successful outcome could lead to a non-invasive, reliable biomarker recognized by the FDA’s Biomarker Qualification Program. This would improve patient care and provide a valuable tool for clinical trials, addressing the current gap in drug development for rare diseases.
Currently, there are no FDA-approved pharmacotherapies for PSC, with liver transplantation being the only life-saving intervention. This makes the accurate characterization and monitoring of disease progression crucial for developing effective treatments. Pharmaceutical companies currently lack reliable, non-invasive biomarkers to efficiently track the effects of new treatments. Perspectum’s research aims to address this critical need. This grant builds upon Perspectum’s existing participation in the FDA’s Biomarker Qualification Program. The funding will allow Perspectum to gather evidence demonstrating the biomarker’s potential to assess therapeutic changes, advancing their mission to develop transformative biomarkers for rare disease treatment.
Perspectum’s technology, MRCP+, enhances the visualization and quantitative assessment of the biliary tree and pancreatic duct. Based on non-contrast Magnetic Resonance Cholangiopancreatography (MRCP) images, MRCP+ allows physicians to more accurately evaluate hepatobiliary structures. This leads to improved diagnosis, staging, and disease monitoring. MRCP+ is currently available for clinical use, holding both FDA 510(k) clearance and CE marking.
Perspectum is a global medical technology company with offices in the U.K. and the U.S. They are focused on developing digital technologies to improve the care of patients with chronic metabolic disease, multi-organ diseases, and cancer. Their work centers on precision medicine using advanced imaging, aiming to empower patients and clinicians through quantitative health assessments. These assessments enable early detection, diagnosis, monitoring, and targeted treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
