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Qiagen MDx Sample Processing Platform Garners CE-IVD Mark

NEW YORK – Qiagen said on Tuesday that its QiaCube Connect MDx automated sample processing platforms for molecular diagnostic labs has received the CE-IVD mark.

The platform is now available to molecular diagnostic labs in the EU. Qiagen said it is also available in the US, Canada, and other markets but does not yet have other regulatory approvals. Qiagen is currently pursuing those approvals individually, a company spokesperson said in an email.

QiaCube Connect MDx is part of the QiaCube product line (including QiaCube Connect and QiaCube HT for life sciences research), but is designed specifically for in vitro diagnostic applications. It can be used with Qiagen's QiaAmp DSP kits and PaxGene Blood RNA extraction kits.

Th fully automated platform is compliant with medical device design standards and regulations, and can be used with more than 80 Qiagen kits and more than 140 standard protocols, including preparation of SARS-CoV-2 and other viral samples for diagnostic testing. Specifically, the system eliminates manual processing by automating the lysis, bind, wash, and elute steps of Qiagen's spin column technology for DNA, RNA, and protein sample processing.

"Many labs are currently facing huge demand for testing, and an increasing complexity of sample types and protocols," Jean-Pascal Viola, senior vice president, head of molecular diagnostics and corporate business development at Qiagen, said in a statement. "Customer feedback on QiaCube Connect for life sciences applications has been overwhelmingly positive. Given that many processes in molecular diagnostics also require efficiency, automation, and connectivity, it was a natural progression to develop this solution for use in diagnostics as well."