SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, announced CE (ConformitéEuropéenne) Mark approval for SeekInClarityTM Cancer Treatment Response Monitoring Kit and is now ready to launch this test in European Union and other countries that recognize CE mark.
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Only up to one third of patients could clinically benefit from therapeutic treatment for cancer. The use of ctDNA as a marker of tumor burden is a new approach for treatment response monitoring. Emerging evidence has indicated that the presence of ctDNA may precede radiological relapse. According to RECIST criteria, traditional imaging techniques require four to six treatment cycles to determine the effectiveness of a particular treatment for a particular patient, in contrast noninvasive ctDNA detection may provide complementary evaluation as early as one cycle of treatment. The potential of dynamic monitoring technology lies in its ability to detect tumor recurrence earlier than traditional imaging, to evaluate prognosis effectively, and to eventually help patients improve survival rate. As a blood-based assay, ctDNA can overcome shortcomings of cancer tissue accessibility, radiation damage and tumor heterogeneity, and as a result, is increasingly used to guide cancer treatment.
“SeekIn ClarityTM Cancer Treatment Response Monitoring Kit is developed by a combination strategy based on shallow whole-genome sequencing (sWGS) and protein analysis (PTMs) in blood. We utilize Molecular Response Index (MRI) model to calculate molecular tumor burden (MTB) so that we can fully capture the overall genomic landscape of a tumor and better evaluate the efficacy of various therapies including chemotherapy, targeted therapy, immunotherapy or combination therapy,” Mao Mao, M.D., Ph.D., SeekIn’s founder and CEO, said in a statement. “CE marking represents a significant milestone for SeekIn to realize the commercialization and compliance process of therapy evaluation. SeekIn will bring SeekInClarity test to patients and healthcare providers in Europe. We will continue our efforts to meet additional regulatory requirements in Europe, and to obtain global regulatory approvals in other territories such as China and Japan.”