Periodic Reporting for period 1 - PANOSTICS (The AA2-Ratio: A Novel Diagnostic Biomarker for Primary Aldosteronism) Reporting period: 2015-04-01 to 2015-08-31 Summary of the context and overall objectives of the project PANOSTICS is a biomarker implementation project conducted by Attoquant Diagnostics GmbH, a mass spectrometry service provider based in Vienna, Austria. Attoquant is specialized in the quantification of peptide hormones in biological samples by mass spectrometry, with a special focus on the patient specific profiling of the Renin-Angiotensin-Aldosterone-System, a peptide hormone system that is critically involved in the regulation of blood pressure. Attoquant’s services like the proprietary RAS-FingerprintTM are appreciated by research groups and biotech companies in the field world-wide and represent high quality diagnostic tools that are used in biomarker research and for the development of personalized treatment schemes in cardiovascular diseases like hypertension. The main objective of this Phase I of PANOSTICS was the development of a business and commercialization strategy for the validation and clinical implementation of the AA2-Ratio as a novel diagnostic biomarker for primary aldosteronism (PA) in hypertensive patients. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Technical and economic risks were assessed in detail and national healthcare systems as well as regulatory requirements were analyzed in terms of financial and regulatory aspects in order to identify preferred sites of market entry. Clinical centers being specialized in the diagnosis of PA have been identified and a validation study aimed to proof the enhanced diagnostic performance of the AA2-Ratio in the detection of PA has been designed under consideration of statistical requirements. Different commercialization scenarios have been assessed in terms of economic feasibility and marketing and distribution strategies for target markets have been developed. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) The AA2-Ratio represents a novel concept of PA diagnostics that is applicable in patients on anti-hypertensive therapy. This serves as the basis for the widespread implementation of PA screening into clinical routine of hypertension management, which would greatly improve the cure rate for PA and therefore prevent a significant number of cardiovascular events caused by uncontrolled hypertension. The focus of this project was the development of an implementation and commercialization plan aiming to make the AA2-Ratio available for hypertensive patients in Europe. The test will be based on the quantification of certain hormones in patient serum samples by mass spectrometry and will be offered as a diagnostic service to specialized clinical centersPA is a severe, but curable form of treatment resistant hypertension. Treatment resistant hypertension affects more than 1 out of 50 Europeans and clinical guidelines recommend screening for PA among this high cardiovascular risk patient cohort. Unfortunately, adherence to these guidelines in clinical practice is poor, which is caused by the low diagnostic performance of currently available tests in patients on anti-hypertensive therapy and results in a high number of preventable cardiovascular events. The broad implementation of the AA2-Ratio into clinical practice would result in an improvement of the cure rate for PA and therefore prevent hypertension associated cardiovascular events, which are major cost drivers for health care systems in Europe. The AA2-Ratio - Direct Ways in the Diagnosis of Primary Aldosteronism
