Barcelona – September 19, 2025 – ADmit Therapeutics S.L. announced today that its disruptive blood test for the prognosis of Alzheimer’s dementia, the MAP-AD® Test, has received the CE Mark under the In Vitro Diagnostic Regulation (IVDR, 2017/746). This certification confirms that the test complies with the European Union’s strict safety and performance standards, a significant milestone for the company and a contribution to providing advanced, personalized, and precision solutions for the early management of Alzheimer’s disease (AD).
Addressing a Critical Gap in Clinical Practice
Current diagnostic approaches for AD rely on identifying the presence of neuropathological changes associated with the onset of amyloid plaques in the brain, recently through blood tests. While the detection of amyloid proteinopathy serves as a central biomarker for the disease, a significant limitation lies in its lack of a direct correlation with cognitive decline, which creates a critical gap in patient prognosis. The MAP-AD® test is specifically designed to address this challenge.
The MAP-AD® Test
The MAP-AD® Test is a qualitative in vitro diagnostic (IVD) blood test for the prognosis of the progression from Mild Cognitive Impairment to AD dementia in adult patients between 55 and 85 years old. It consists of MAP-AD® Software and MAP-AD® Oligos. The MAP-AD® Software securely processes patient data, integrating the data from the new mitochondrial biomarkers obtained in the analysis of a blood sample in the laboratory using MAP-AD® Oligos, together with clinical data, for providing the prognosis of progression to dementia due to AD.
“Obtaining CE-IVDR certification for our prognostic test is a huge achievement for ADmit Therapeutics. Our solution is an AI-algorithm based on a holistic view of the disease, linking the biology of AD, bioenergetic decline, cognitive status, and key risk factors, which allows it to distinguish patients likely to progress to AD dementia from those who will remain cognitively stable, even in individuals with an amyloid-negative status,” said Dr. Marta Barrachina, CEO and co-founder of ADmit Therapeutics. She added: “It underscores our unwavering commitment to developing reliable, high-quality prognostic tools that can make a real difference in patient care.”
Looking to the future, ADmit Therapeutics is focused on obtaining additional regulatory approvals to offer its solution globally. The company remains committed to its mission of transforming patient health through precision diagnostics.
About ADmit Therapeutics
ADmit Therapeutics S.L., founded in 2017 in Barcelona, is a biotechnology company that emerged from the Bellvitge Biomedical Research Institute. Its goal is to create innovative solutions that help detect and manage neurodegenerative diseases, supporting neurologists so they can offer better treatment to affected people. The company has raised 10 million euros since its inception, from public and private investments from important and prestigious organizations such as the Alzheimer’s Drug Discovery Foundation, the EIC Fund, Clave Capital, Bstartup10, Ship2B, EIT Health, the Ministry of Science, Innovation and Universities, WA4STEAM, and other private investors.
