Research & Development
Ender Diagnostics Receives FDA Notification for Rapid and Reliable COVID-19 Tests
24 November 2020 - - The two COVID-19 tests from Switzerland-based Ender Diagnostics have received FDA approval, marking the entry of the Swiss company into the US market, the company said.

With the continued surge of COVID-19 cases in the US, the American subsidiary of ender diagnostics, ender diagnostics North America, is ready to deliver rapid and reliable COVID-19 testing kits to diagnostic laboratories wishing to increase their testing capacities.

The company is proud to be actively contributing to successfully manage the pandemic. The ender products are highly accurate and fast, allowing laboratories to increase their throughput significantly.

ender LAB and ender MASS are in-vitro diagnostic test kits based on a rapid molecular isothermal nucleic acid amplification technology. 

Both ender LAB and ender MASS are designed for use by laboratory professionals or trained operators on standard real-time PCR devices.

For ender LAB, the result is provided within 30 minutes after the extraction of the viral RNA, which makes it significantly faster than typically used PCR tests.

With a sensitivity of 97.7% and a specificity of 100%, ender LAB is the appropriate solution for a clinical set-up, where all infected individuals must be identified reliably.

The ender MASS test does not require a conventional RNA extraction, saving hours of lab time and decreasing the use of consumables.

It detects the SARS-CoV-2 virus within 30 minutes after sample preparation, making it the optimal laboratory-based solution for mass-testing in a public health set-up.

ender diagnostics is a private company headquartered in Bern, Switzerland, and has a US subsidiary with offices in New Jersey and Miami, specialized in developing molecular diagnostic test kits for the rapid and reliable detection of SARS-CoV-2, the virus which causes COVID-19.

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-how and financing.


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