BioEcho Wins In Vitro Diagnostic CE Mark Approval for SARS-CoV-2 RNA Extraction Kit

BioEcho has received the In Vitro Diagnostic CE Mark Approval for its new SARS-CoV-2 RNA extraction kit which enables viral RNA purification within 5 minutes.

BioEcho Life Sciences, a progressive biotechnology company developing novel DNA & RNA extraction tools and methods, has announced that the company received the CE-IVD mark approval for their EchoLUTION Viral RNA/DNA Swab Kit product line, which has been classified as a medical device Class A IVD in the European Union.

To secure this certification the products have to comply with the regulation 2017/746 of the European Parliament and of the Council from April 2017 on in vitro diagnostic medical devices (IVDR).

Dr. Frank Schäfer, Managing Director at BioEcho commented:

“Receiving the CE-IVD mark for our viral RNA and DNA extraction kit does not only officially substantiate our internally set quality standards but also facilitates the global fight against COVID-19 by providing faster test solutions.”

In recent times, the CE-mark is particularly helpful because validation processes in diagnostic laboratories can be very time-consuming. The CE-mark facilitates fast and easy integration into the diagnostic laboratory workflow routine.

EchoLUTION RNA extraction method accelerates SARS-CoV-2 PCR tests

The EchoLUTION Viral RNA/DNA Swab Kit enables a very fast and efficient viral RNA purification within just 5 minutes. By contrast to conventional bind-wash-elute methods, with the EchoLUTION RNA extraction method, all impurities are held back by the purification matrix and the nucleic acid is running through in a single purification step. This results in highly pure RNA for extremely reliable RT-qPCR with no inhibitory effects or reagent carry-over. The speed of the extraction method contributes to faster COVID-19 tests in general. The system is compatible with commonly available transport media.

BioEcho has established a highly flexible working environment, including scalable production capacities, which has allowed them to avoid any backorder circumstances even during these periods of high demands. The products are available in Germany through direct sales and globally via distributors or upon request.

About BioEcho

BioEcho Life Sciences GmbH is a dynamically growing, innovative company founded in 2016 in Germany by a team of industry experts from the field of nucleic acid purification. The company uses its know-how to overcome the limitations of conventional methods in molecular biology.

Just like its customers, BioEcho’s mission is to always be one step ahead. Therefore, they develop and produce next-generation technologies and products to enable molecular biology and diagnostic laboratory workflows of higher convenience, higher robustness, and higher sustainability due to less hazardous reagents and reduced plastic waste.

One of BioEcho’s top assets is having close customer relationships. For more information about the EchoLUTION Viral RNA/DNA Swab Kit, please visit the company website or contact the BioEcho team for any request via