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SeekIn Receives CE Mark Approval for OncoSeek® Multi-Cancer Detection Test

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SeekIn Receives CE Mark Approval for OncoSeek® Multi-Cancer Detection Test | Pharmtech Focus

SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, today announced CE (Conformité Européenne) Mark approval for OncoSeek® Multi-Cancer Detection Test and is now ready to launch this test in European Union and other countries that recognize CE mark.

Early detection of cancer is paramount for improving treatment strategies and survival outcomes. Immunological measurement of blood-based tumor markers has been performed over many years on a large population of individuals in screening malignancies at early or preclinical stages. This method has significant advantages, including being non-invasive, automated, quantitative, objective, and relatively inexpensive compared with histology, endoscopy, and imaging. However, the relatively low sensitivity and specificity for early cancer identification have generally limited the widespread use of single biomarkers for screening purposes in a general population setting.

OncoSeek®, a customized panel of seven selected protein tumor markers (PTMs) including AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA21-1, quantified them on Roche cobas e411 instrument performing for 12 common cancers early detection. It established a multivariate algorism for cancer detection by integrating the measurement of these seven PTMs and age of the subject which was empowered by artificial intelligence technology. The results showed that OncoSeek significantly outperformed the traditional clinical method, representing a novel blood-based test for multiple cancer detection.

“This is a very cost-effective cancer early detection test, making it possible for some low-income people to receive cancer screening,” Mao Mao, M.D., Ph.D., SeekIn’s founder and CEO, said in a statement. “Based on the analysis of ~10,000 plasma samples, with specificity at ~90%, the sensitivity of OncoSeek® for cancer detection is almost two times higher than that of using current clinical method. At the same time, this method is very simple and fast, which can quickly and accurately issue a test report for the subject. CE Marking represents a significant milestone for SeekIn in bringing OncoSeek® test to the patients and healthcare providers in Europe. We will continue our efforts to meet additional regulatory requirements in Europe, and to obtain regulatory approvals in the other territories such as China.”

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