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Seegene Obtains CE Mark for Self-Collection Swab With Four SARS-CoV-2 MDx Tests

NEW YORK ─ Seegene said Wednesday that it has obtained CE marking for the use of its Combo Swab self-collection device with four of the firm's SARS-CoV-2 molecular diagnostic assays, enabling its use in the EU and other regions that accept the designation.

Combo Swab can be used with Seegene's multiplex Allplex SARS-CoV-2 Assay, Allplex SARS-CoV-2 Master Assay, Allplex SARS-CoV-2 Variants I Assay, and Allplex SARS-CoV-2/FluA/FluB/RSV Assay.

The self-collection device enables specimen collection from nasal and oral cavities under the supervision of a healthcare professional, and its availability with the Seegene RT-PCR-based diagnostic assays can improve testing efficiency by enabling a reduction in the time for testing of large groups, the firm said.

South Korea-based Seegene added that the new testing option will also expand access to COVID-19 testing and reduce workloads for healthcare workers.

Further, Combo Swab can reduce the risk of accidental exposure to SARS-CoV-2 for clinicians who can maintain a safe distance during testing, the firm said, adding that clinical data show that the device enables a testing accuracy of more than 96 percent.

"With the rapid spread of the Delta variant, surveillance testing is the key to curb the further spread of COVID-19," Min-Cheol Lee, the firm's chief technology officer, said in a statement.

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