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Diagnostic autoantibody assay to stratify bone marrow failure diseases

Periodic Reporting for period 1 - STRATIFY (Diagnostic autoantibody assay to stratify bone marrow failure diseases)

Reporting period: 2020-01-01 to 2021-12-31

The goal of STRATIFY was to validate a novel autoantibody to serve as a diagnostic test in aplastic anemia, which is a rare hematological autoimmune disease. We analyzed a cohort of over 400 patients with aplastic anemia, together with a control cohort of more than 800 plasma samples collected from healthy controls and patients with a wide array of different diseases. We showed that our novel biomarker is highly specific for aplastic anemia – it was not detected in any healthy controls and only occasionally seen in patients with other autoimmune diseases. Moreover, especially in older patients, the sensitivity of the novel diagnostic autoantibody was excellent.

Together with commercialization professionals from the Helsinki Innovation Services (HIS), we produced communication material and performed industry outreach, as well as submitted patent applications on both national and EU level. The non-confidential one pager and the confidential presentation covering the scientific findings were used to present the project to industry representatives and these tools will be used further after the funding period.

In conclusion, all the scientific goals of STRATIFY were reached. The newly discovered biomarker for aplastic anemia was confirmed as a promising candidate to be further developed for routine clinical use. IPR protection and the commercialization process were initiated, and the project will be continued.
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