ender diagnostics launches second CE-certified COVID-19 test – enabling rapid, high volume testing in schools, manufacturing facilities, hospitals and care homes
Bern, Switzerland, 12 August 2020
- ender MASS detects SARS-CoV-2 in 30 minutes thanks to a simplified and accelerated process
- Enables flexible testing in critical settings, with capacity to run up to eight times more tests than conventional PCRs
- US FDA clearance anticipated in September 2020
- Development of mobile, point-of-care test moving rapidly ahead
ender diagnostics, a Swiss company specializing in the development of rapid molecular biological tests, today announced the launch of ender MASS, its second CE-marked test to detect SARS-CoV-2, the virus which causes COVID-19. ender MASS is highly specific, easy-to-use and fast – providing results from a simple nasopharyngeal swab in only 30 minutes. It is designed to enable rapid diagnosis for critical settings including schools, manufacturing facilities, travel, hospitals and care homes, as well as enabling centralized laboratories to accelerate and increase throughput.
Reliable and rapid testing has emerged as one of the most important factors in controlling and limiting the spread of infection in the COVID-19 pandemic. One of the most critical challenges around the world has been limited testing capacity in laboratories due to shortages of viral RNA extraction kits, testing reagents and qualified technicians.
ender diagnostics specializes in isothermal PCR-based test kits for laboratory and on-site diagnosis. It has already launched the ender LAB test in June 2020, which enables laboratories to directly detect SARS-CoV-2 on standard real-time PCR (polymerase chain reaction) devices within 30 minutes, significantly faster than currently available PCR tests, which take several hours. The newly approved ender MASS offers further benefits by enabling detection in a simplified and accelerated process, considerably reducing the workload for medical professionals and laboratories. It is designed to enable on-site and pop-up labs to operate rapid testing in diverse settings, potentially including travel-related locations such as airports and cruise ships. The simplified workflows and analysis mean laboratories can process up to eight times as many tests compared to conventional PCR testing over the same period.
Tim Pfister, CEO of ender diagnostics, comments: «Constant rapid and flexible testing is the key to controlling the Covid-19 pandemic and enabling countries and economies around the world to open up and recover. Combined with a mobile lab infrastructure, the fast and easy-to-use ender MASS test would enable detection of coronavirus infection directly on-site in a wide range of locations, such as schools, hospitals, care homes, factories and in challenging locations such as airports and cruise ships prior to boarding. With a fully portable version of our testing system also advancing rapidly, ender diagnostics is well placed to make a significant contribution to helping avoid partial or large-scale lockdowns around the world.»
The company is also moving ahead with development of a mobile point-of-care test for acute COVID-19 cases, called ender MOBILE. Launch in Europe is planned during fall this year.
About ender diagnostics
ender diagnostics is a private company headquartered in Bern, Switzerland, and with US offices in Miami. ender diagnostics focuses on the development of rapid molecular tests for the detection of SARS-CoV-2. The ender team has extensive experience in developing molecular biological rapid tests for infectious diseases. The company is supported by several private investors with know.