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SeekIn Nabs CE Mark for Cancer Assay

NEW YORK — Cancer diagnostics firm SeekIn said Monday it has secured CE marking for its OncoSeek Multi-Cancer Detection Test.

The Shenzhen, China-based biotechnology firm said it is ready to launch the test in Europe and other countries that recognize the CE mark. The firm also is working to obtain regulatory approvals in China and other regions.

The panel is implemented on the Roche Cobas e411 platform. SeekIn officials said the panel is noninvasive, automated, quantitative, objective, and inexpensive in comparison with histology, endoscopy, and imaging, and it could help expand access to early cancer detection.

The OncoSeek panel is used to quantify seven protein tumor biomarkers in blood and analyzed with the patient's age to detect 12 common types of cancer. The biomarkers include AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA21-1. The company said the results outperform traditional cancer detection methods.

SeekIn CEO Mao Mao said in the announcement that based on an analysis of 10,000 plasma samples, the OncoSeek panel had approximately 90 percent specificity and a sensitivity "almost two times higher than that of using current clinical method."

SeekIn also received CE marking earlier this year for its SeekInCare Cancer Detection Kit, LeukoPrint Molecular Karyotyping Kit used to diagnose and stratify leukemia patients, and SeekInClarity Cancer Treatment Response Monitoring Kit.