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Ender Diagnostics Receives CE Mark for SARS-CoV-2 PCR Test

NEW YORK ─ Ender Diagnostics on Wednesday announced it has received CE marking for its ender Mass PCR test to detect SARS-CoV-2.

The Bern, Switzerland-based firm has launched the test for use in the European Union and other countries that accept the designation.

The ender Mass test, designed to provide results from a nasopharyngeal swab in 30 minutes, enables on-site and pop-up labs to operate rapid testing in diverse settings, the company said. The test enables rapid diagnosis in critical settings including schools, manufacturing facilities, hospitals, and care homes, and it enables centralized laboratories to accelerate and increase throughput.

Ender Diagnostics develops isothermal amplification-based test kits for laboratory and on-site diagnosis. The company noted it launched a second test, ender Lab, in June 2020, that enables laboratories to detect SARS-CoV-2 on standard real-time PCR instruments within 30 minutes.

The company said the test's simplified workflows and analysis mean laboratories can process up to eight times as many tests compared to conventional PCR testing over the same period.

"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," Tim Pfister, the firm's CEO, said in a statement.

The company said it is developing a mobile point-of-care test for acute COVID-19 cases, with a planned launch in Europe during the fall.