SeekIn Receives CE-IVD Mark Approval for PanCanSeek® Cancer Mutation Detection Kit

First-of-its-kind one-for-all cancer mutation detection test

SHENZHEN,China,Dec. 19,2022 -- SeekIn Inc,a leader in blood-based cancer early detection and monitoring technology,today announced CE (Conformité Européenne) Mark approval for PanCanSeek® Cancer Mutation Detection Kit and is now ready to launch this test in European Union and other countries that recognize CE-IVD Mark.

Cancer is a multiparametric molecular disease. Genetic profiling is a routine component of the diagnostic workup for an increasing number of cancers and is used to predict clinical outcomes and responses to targeted therapies. However,different cancer types may have different driver genes or special DNA alteration types. At present,multiple platforms to obtain the genetic information are needed for clinical management,which increase the cost and require more samples. Whole-genome sequencing (WGS) is an unbiased method of detecting all types of mutations and could potentially be used to replace current testing schemes. With the development of sequencing technology,together with the increased cost-effectiveness of next-generation sequencing (NGS),WGS and the associated data analysis and interpretation have matured from a research-use-only tool to a clinical-grade technology. Furthermore,the turnaround time has become clinically acceptable. These features of WGS suggest that it could improve genomic profiling in patients with cancer. In addition,genomic analysis is essential for diagnostic classification and risk assessment in patients with leukemia.

PanCanSeek® is developed as the world's first integrated solution for leukemia cytogenetics and molecular diagnostics. It uses high-depth WGS,which can cover four different detection techniques – karyotyping for CNV,FISH for gene fusion,qPCR for single mutation and targeted NGS panel for multiple mutations. All the mutation information of the genome can be obtained from this single test,so that molecular typing,prognosis stratification,treatment guidance,and efficacy prediction can be performed faster,more accurately and more effectively.

"SeekIn not only focuses on solid tumors,but also develops its own cutting-edge technology for hematologic malignancies. PanCanSeek® Cancer Mutation Detection Kit is a streamlined approach by using whole-genome sequencing for genomic profiling of leukemia patients. This test detects all types of genomic mutations. Based on the mutational information,hematologists can make a comprehensive evaluation of disease status and formulate a new treatment plan," Mao Mao,M.D.,Ph.D.,SeekIn's founder and CEO,said in a statement. "In addition,PanCanSeek® has received CE-IVD Mark approval which represents a significant milestone for SeekIn. This CE-IVD Mark demonstrates the accuracy of this test and facilitates the adoption of it in the European market."

About PanCanSeek®

PanCanSeek® requires ~2ml bone marrow from leukemia patients for high-depth WGS (50x coverage) to detect all types of mutations including single nucleotide variants (SNVs),small insertion and deletion (InDels),copy number aberrations (CNAs),and structure variants (SVs). The test is intended to be used in molecular classification,and efficacy prediction. PanCanSeek® Cancer Mutation Detection Kit is also suitable for patient who is suffering from complex leukemia by analyzing the genomic profiling result to explore the genetic causes of the disease and find the appropriate treatment strategies.

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 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.

View original content:https://www.prnewswire.com/news-releases/seekin-receives-ce-ivd-mark-approval-for-pancanseek-cancer-mutation-detection-kit-301705978.html