ender diagnostics launches their second CE-certified COVID-19 test, which will enable rapid, and high-volume testing in schools, manufacturing facilities, hospitals, and care homes.

One of the essential elements for the control of COVID-19 is reliable and rapid testing. However, testing capacity is a significant global challenge due to shortages in healthcare services.

Our portfolio company ender diagnostics launches ender MASS, its second CE-marked test to detect SARS-CoV-2, the virus behind the COVID-19 pandemic. With ender MASS, it only takes 30 minutes to diagnose COVID-19. It considerably reduces the workload for medical professionals and laboratories. Moreover, it enables on-site and pop-up labs to operate rapid testing in diverse settings, potentially including travel-related locations.

«Constant rapid and flexible testing is key in controlling the COVID-19 pandemic, and enabling countries and economies around the world to open up and recover.» comments Tim Pfister, CEO of ender diagnostics «ender diagnostics is well placed to make a significant impact to help avoid partial or large-scale lockdowns around the world. » 

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HEMEX supports the ender team with clinical, regulatory, and marketing services. HEMEX’s regulatory experts will support the CE-certification of the test as an in vitro diagnostic medical device under the European In Vitro Diagnostic Regulation (IVDR). 

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