Omixon launches AzureSeq-200 CE kit for one-step RT-PCR detection of SARS-CoV-2 and announces exclusive agreement with SeqOnce Biosciences
BUDAPEST, PASADENA, Calif. and CAMBRIDGE, Mass., Oct. 7, 2020 /PRNewswire-PRWeb/ -- Global molecular diagnostics company Omixon, headquartered in Budapest with US offices in Cambridge, MA, announce the launch of Omixon AzureSeq-200 CE IVD kit for the detection of novel coronavirus SARS-CoV-2 by RT-PCR. The AzureSeq-200 CE IVD technology uses a revolutionary workflow that detects viral RNA without RNA-extraction. To our knowledge, this is the first CE-marked, qPCR method clinically validated for direct viral detection without RNA extraction and without any specialized closed system.
Omixon signed an exclusive licensing agreement with SeqOnce Biosciences to CE-mark and distribute the AzureSeq-200 CE IVD RT-PCR kit in Europe, Middle East and Africa. The AzureSeq-200 CE IVD is the first in vitro diagnostic kit introduced to the European, Middle Eastern and African market that does not require RNA extraction without proprietary closed systems. Omixon carried out the validation of the AzureSeq-200 CE IVD kit to determine its sensitivity, specificity and limit of detection to conform to the conformity assessment for in vitro diagnostic use.
"The standard way of PCR, generally applied for the identification of SARS-CoV-2 virus detects
RNA extracted from the sample. RNA extraction is time consuming (takes several hours) thus requiring a greater amount of human resources, as well as being reagent intensive and expensive. Specific reagents are required, which are expensive and often in short supply these days. For these reasons, there is an urgent need for a qPCR method using original specimens without RNA extraction. In our lab the AzureSeq-200 CE IVD test provided fully concordant results with those obtained with classic qPCR tests. If we implement it, the turnaround time for reports will be shortened significantly," says Professor dr. Barna Vasarhelyi, Director of the Institute for Laboratory Medicine at Semmelweis University.
"While Omixon maintains its focus on transplant patients, we felt that we had the competence to bring the benefits of innovation by SeqOnce to the EMEA market in the form of a regulatory compliant product. Curbing coronavirus transmission is vital for both transplant recipients and as well as for the general population," said Attila Bérces, CEO of Omixon.
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Contacts at Omixon
Attila Berces, PhD
Chief Executive Officer
attila.berces@omixon.com
+36 70 574 8001
Nora Nagy, MBA
Head of Market Development and Marketing
nora.nagy@omixon.com
+36 30 633 3050
About Omixon
Omixon is a global molecular diagnostics company, headquartered in Budapest, Hungary, with US offices in Cambridge, MA that commercializes disruptive technologies for clinical and research laboratories. Omixon's flagship product, Holotype HLA, is the world's leading NGS-based HLA genotyping product that delivers the most accurate high-resolution HLA genotyping available, and is used in more than 50 hospitals worldwide. Omixon's research software, HLA Explore analyzes data from any sequencing technology and determines HLA genotypes from Whole Exome/Genome Sequencing experiments. Omixon maintains an active grant-funded research program with a product pipeline focused on pre- and post-transplantation, and HLA genotyping applications beyond transplantation. For more information, visit http://www.omixon.com
SOURCE Omixon Biocomputing Kft.
