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ender diagnostics Receives FDA Notification for Rapid and Reliable COVID-19 Tests

·2-min read
  • Two ender diagnostics products – ender LAB and ender MASS – receive FDA notification

  • Ready to be launched to the USA

  • Rapid, reliable & cost-effective COVID-19 tests in 30 minutes

The two ender COVID-19 tests received the FDA notification, marking the entry of the Swiss company into the US market. 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. Heidi Horsch, the ender diagnostics CMO, outlines the advantage of ender MASS: «It enables the implementation of a sustainable testing strategy by reliably detecting contagious individuals carrying high viral loads. Because ender MASS only takes 30 minutes, it enables laboratories to significantly increase their testing throughput as well as addressing the supply chain shortages experienced during this pandemic».

For more information about ender diagnostics products please contact:

salesUS@enderdiagnostics.com
sales@enderdiagnostics.com

About ender diagnostics

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.

For more information visit the website www.enderdiagnostics.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20201124005684/en/

Contacts

For media inquiries please contact:
Tim Pfister, CEO, t.pfister@enderdiagnostics.com, +41 (0)76 469 37 46