Swiss-based start-up ender diagnostics develops rapid molecular tests for the detection of SARS-CoV-2. The first rapid test has just been CE -certified and can now be used in laboratories worldwide.
What makes the ender LAB and subsequent ender MAS test outstanding is not just that the result is obtained within 30 minutes, but also that its accuracy is comparable to the current gold standard. The ender team has extensive experience in developing molecular biological rapid tests.
PR_CE mark for ender LAB_20200615
HEMEX supports ender’s team with clinical, regulatory and marketing services. HEMEX’s regulatory experts will support with the CE-certification of the test as an in vitro diagnostic medical device under the European In Vitro Diagnostic Regulation (IVDR).