BioEcho Life Sciences announces that the company has recently received CE-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 obtain 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).
"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", said Dr. Frank Schäfer, Managing Director at BioEcho.
In current times, the CE-mark is especially valuable because validation processes in diagnostic laboratories are time-consuming. The CE-mark facilitates easy and quick integration into the diagnostic laboratory routine.
EchoLUTION RNA extraction method speeds up SARS-CoV-2 PCR tests
The EchoLUTION Viral RNA/DNA Swab Kit allows a very fast and efficient viral RNA purification within just 5 minutes. Unlike conventional bind-wash-elute methods, 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 built a highly flexible working environment, including scalable production capacities, which has enabled them to avoid any backorder situations even during these periods of high demands.
The products are available in Germany via direct sales and worldwide via distributors or upon request.
To obtain 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).
"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", said Dr. Frank Schäfer, Managing Director at BioEcho.
In current times, the CE-mark is especially valuable because validation processes in diagnostic laboratories are time-consuming. The CE-mark facilitates easy and quick integration into the diagnostic laboratory routine.
EchoLUTION RNA extraction method speeds up SARS-CoV-2 PCR tests
The EchoLUTION Viral RNA/DNA Swab Kit allows a very fast and efficient viral RNA purification within just 5 minutes. Unlike conventional bind-wash-elute methods, 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 built a highly flexible working environment, including scalable production capacities, which has enabled them to avoid any backorder situations even during these periods of high demands.
The products are available in Germany via direct sales and worldwide via distributors or upon request.
