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ABCDx | Submit StrokeCheck for clearance in the US & EU

08.12.2020
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Targeting launches in the US & EU: 2021

 

Swiss diagnostics firm ABCDx is developing a point-of-care blood test for stroke to enable faster diagnosis and treatment of the condition. Targeting launches in the US and EU next year, the Geneva startup is now prepping for Regulatory Submissions.

The Geneva-based ABCDx presented data from an ongoing clinical study of the test at the World Stroke Organisation Conference (WSOC) held last month in Vienna. In data from 500 patients, the test was able to distinguish between sufferers of ischemic and hemorrhagic stroke with a sensitivity of 50 percent and a specificity of 100 percent.

The company with offices at Campus Biotech in Geneva (Switzerland) is planning to submit the test, called StrokeCheck, to the US Food and Drug Administration in 2021 and aims to launch it in the US following FDA clearance. To support commercialisation of the test, it is planning a Series A funding round targeting between $5 million and $10 million that it aims to close in Q1 2021.

 

Full Press Release.