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

Tuesday, September 13, 2022

SeekIn Inc., a leading provider of blood-based cancer early detection and monitoring technology, has announced that its OncoSeek® Multi-Cancer Detection Test has received CE (Conformité Européenne) Mark approval. This approval enables the company to launch the test in the European Union and other countries that recognize the CE mark.

Early detection of cancer is crucial for improving treatment strategies and patient outcomes. Blood-based tumor marker measurements have been extensively used over the years to screen for malignancies at early or preclinical stages. This method offers several advantages, including non-invasiveness, automation, quantification, objectivity, and relative affordability compared to histology, endoscopy, and imaging. However, the limited sensitivity and specificity of single biomarkers for early cancer identification have hindered their widespread use in general population screening.

OncoSeek® is a specialized panel that includes seven protein tumor markers (PTMs): AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA21-1. These PTMs are quantified using the Roche cobas e411 instrument, enabling the early detection of 12 common cancers. SeekIn has developed a multivariate algorithm for cancer detection by integrating the measurements of these seven PTMs and the age of the individual, powered by artificial intelligence technology. The results have demonstrated that OncoSeek® outperforms traditional clinical methods, offering a novel blood-based test for detecting multiple types of cancer.

"This is a highly cost-effective cancer early detection test, making cancer screening accessible to low-income individuals," stated Dr. Mao Mao, Founder and CEO of SeekIn. "Based on the analysis of approximately 10,000 plasma samples, OncoSeek® exhibits an almost two-fold increase in sensitivity compared to current clinical methods, with a specificity of around 90%. Moreover, this method is simple and fast, enabling rapid and accurate test reporting. Obtaining the CE Mark is a significant milestone for SeekIn, as it allows us to bring the OncoSeek® test to patients and healthcare providers in Europe. We will continue our efforts to meet additional regulatory requirements in Europe and obtain regulatory approvals in other territories, such as China."

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