ADmit Therapeutics (ADmit) implemented a new generation sequencing infrastructure in-house for the epigenetic analysis of samples encouraging the optimization and the introduction of several improvements in their protocols for time-effective management of the the MAP-AD platform. The standardization of the protocols was consolidated by the establishment of a Quality Management System (QMS) certified with the ISO13485 and based on the requirements of the European regulation for in vitro diagnostic devices (IVDR).
The company designed and developed the MAP-AD Test®, a medical device comprised by a kit with reagents for the analysis of distinctive methylation patterns in blood samples, and a dedicated medical software that computes the probability of progression to ADD using the methylation patterns and patient clinical information. This is the first epigenetic prognostic model, amyloid-beta (Aβ) independent, intended to provide the prognosis of progression from MCI to ADD. The product validation and verification, including the analytical validation, were performed to demonstrate the robustness of the medical device developed.
During the project, a multicentric observational study was performed to evaluate the clinical performance of the MAP-AD Test®. The recruitment of patients for the study was hampered by the COVID-19 pandemic worldwide situation. Nonetheless, 600 prospective and retrospective samples from three groups [cognitively normal subjects (CN), MCI patients non-progressed to ADD, and MCI patients that progress to ADD] were collected from Spanish hospitals and private collections, and American and Australian biobanks. The performance of the MAP-AD Test® for the classification of those MCI patients that will progress to ADD yielded a sensitivity and specificity of 95% and 71%, respectively. Moreover, the model showed a positive predictive value of 77% and a negative predictive model of 93%, and an area under the curve (AUC) of 90.3%. No adverse effects or device deficiencies were reported during the clinical performance study. This data was part of the performance evaluation of the test for the CE-mark submission.
The present project allowed to conclude that the MAP-AD Test® is a safe medical device that provides results that correlate with ADD progression in MCI patients. The probability of progression from MCI to ADD can be used by neurologists in patients and the appropriate action may be taken according to standard clinical practice. This cutting-edge technology and previous prototypes have been presented at several international congresses and fairs such as the Clinical Trials on Alzheimer’s Disease (CTAD) Congress, Alzheimer’s & Parkinson’s Disease Conference (AD/PD), and the Bio International Convention (BIO).
Finally, the company closed a €5,4 million Equity Round with Clave Capital, EIC Fund, and Alzheimer’s Drug Discovery Foundation (ADDF), among other investors, allowing the consolidation of the company and start preparing for the market launch of the MAP-AD Test®.
