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

This Blood-based Multi-Cancer Early Detection Test Combines Protein Tumor Markers And Artificial Intelligence

SHENZHEN,China,Sept. 12,2022 --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."

About OncoSeek®

OncoSeek® has been developed as a multiple cancer detection test that uses artificial intelligence to distinguish between cancer cases and healthy cases by calculating the probability of cancer (POC) index based on the plasma levels of seven PTMs (including AFP,and CYFRA21-1) and age of the subjects. OncoSeek is a non-invasive,efficient,and cost-effective approach for multi-cancer early detection (MCED).

About SeekIn

SeekIn Inc is a biotech company founded in early 2018 in Shenzhen,focusing on blood-based pan-cancer early detection utilizing next-generation sequencing and artificial intelligence. Since founded,SeekIn has been committed to providing cutting-edge and cost-effective solutions for cancer early detection,postoperative recurrence monitoring,and treatment response evaluation. SeekIn also developed novel molecular tests for leukemia patients. Its cancer early detection technology has been applied to canines as well. With its proprietary technical advances,SeekIn has launched a number of research and clinical studies in collaboration with top-tier hospitals in China. SeekIn envisions that by leading a new norm for cancer early detection the clinical outcome of mid-/late-stage cancer patients can be reversed and the cancer mortality rate can be reduced by 15%. For more information about SeekIn's cutting-edge technologies and products,visit www.seekincancer.com.

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