SeekIn Receives CE-IVD Mark Approval for SeekInCure® Cancer Recurrence Monitoring Kit

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Nov 28, 2022, 08:00 ET

First-of-its-kind blood-based pan-cancer recurrence monitoring test

SHENZHEN, China, Nov. 28, 2022 /PRNewswire/ -- SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, today announced CE (Conformité Européenne) Mark approval for SeekInCure^® Cancer Recurrence Monitoring Kit and is now ready to launch this test in European Union and other countries that recognize CE-IVD Mark.

Cancer recurrence after the curative resection of the primary tumor arises from minimal residual disease (MRD) not detected in current practice via imaging, laboratory tests, or clinical assessment. Therefore, a sensitive and specific clinical tool that helps identify patients with MRD who are more likely to relapse or allows avoidance of unnecessary and potentially toxic therapy for lower-risk patients with no evidence of MRD is a major unmet need.

SeekInCure^® is applied to monitoring cancer recurrence and risk evaluation for post-operation cancer patients by monitoring the alterations of cancer genome in cell-free DNA (cfDNA) continually, combined with protein tumor markers, equipping big data and artificial intelligence. In addition, this approach does not require tumor analysis.

"This test only requires an 8ml blood draw within a month after radical surgery to assess whether MRD exists, meanwhile, peripheral blood can also be collected regularly after surgery to monitor cancer recurrence. We have conducted a prospective study to evaluate the effectiveness of SeekInCure to detect MRD in patients with hepatocellular carcinoma (HCC), and this study has confirmed the excellent performance of SeekInCure in the detection of MRD and the prognostic value of MRD in HCC patients. In addition, the blood-only features make it to be a cost-effective approach and faster turnaround time to allow clinicians to make a quick treatment decision," Mao Mao, M.D., Ph.D., SeekIn's founder and CEO, said in a statement. "CE-IVD Mark is a recognition of the performance of SeekInCure, and is also a milestone for SeekIn, representing our test may be more widely accessible to cancer patients around the world. We believe that SeekInCure^® can be a powerful tool for MRD detection and recurrence monitoring for the patients after radical surgery."

About SeekInCure^®SeekInCure^® is a blood-based cost-effective and tumor-naïve approach for molecular residual disease (MRD) assessment and recurrence monitoring for all cancer patients with radical surgery. Combining genomic/epigenetic signals (copy-number aberrations (CNA) and fragment size (FS)) and protein tumor markers quantification, the approach dynamically monitors the change of molecular tumor burden (MTB) in blood after surgery to identify patients with MRD who may benefit most from adjuvant therapies and to monitor for recurrence of the disease.

About SeekIn
SeekIn Inc is a biotech company founded in early 2018 in Shenzhen, China, focusing on blood-based pan-cancer early detection utilizing next-generation sequencing and artificial intelligence. Since its founding, 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.

SOURCE SeekIn Inc