Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.