SeekIn Receives CE Mark Approval for SeekInClarity™ Cancer Treatment Response Monitoring Kit
First-of-its-Kind blood-based pan-cancer treatment response monitoring test
SHENZHEN, China, May 25, 2022 /PRNewswire/ -- SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, today announced CE (ConformiteEuropeenne) 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.
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.
"SeekInClarityTM 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."
SeekInClarityTM is the first-in-class blood-based pan-cancer treatment response monitoring test, which uses a cutting edge multivariable molecular tumor burden (MTB) algorithm. Molecular response index (MRI) model maps panoramic cancer genome by shallow whole-genome sequencing (sWGS), combining copy number aberration (CNA)，fragment size (FS) and 7 protein tumor markers, to predict tumor burden and therapeutic efficacy of late-stage cancer patients during treatment, including chemotherapy, target therapy and immunotherapy or combination therapies.
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 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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Source: SeekIn Inc
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