NEW YORK – Molecular diagnostics company Omixon has obtained CE mark for the AzureSeq-200 RT-PCR kit, an extraction-free viral RNA detection kit to detect SARS-CoV-2. The firm had previously signed an exclusive licensing agreement with SeqOnce Biosciences to obtain CE mark and distribute the kit in Europe, the Middle East, and Africa.
Under the licensing deal, Omixon will now sell Omixon branded CE-marked products licensed from SeqOnce in Europe, Middle East, and Africa, while SeqOnce will sell SeqOnce branded AzureSeq products in the rest of the world. Additional terms of the deal were not disclosed.
The AzureSeq-200 CE-IVD workflow detects viral RNA without RNA-extraction. Omixon said in a statement that it is the first CE-marked qPCR method clinically validated for direct viral detection without RNA extraction and without a proprietary closed system.
"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," said Attila Bérces, CEO of Omixon. "Curbing coronavirus transmission is vital for both transplant recipients as well as for the general population."
Barna Vasarhelyi, director of the Institute for Laboratory Medicine at Semmelweis University in Budapest, added that RNA extraction is a time-consuming and intensive use of skilled technician time, and it uses specific reagents which are expensive and frequently in short supply during the pandemic.
"For these reasons, there is an urgent need for a qPCR method using original specimens without RNA extraction," Vasarhelyi said.