International oncology guidelines, such as those from NCCN, ESMO and CSCO, recommend the use of liquid biopsy as an alternative when tumor tissue samples are inaccessible. Currently, most approved NGS IVD kits on ChinaтАЩs market are designed for tumor tissue testing. GeneseeqтАЩs NGS liquid biopsy kit is capable of identifying mutations in multiple key tumor driver genes in a single test with world-leading detection performance, and provides companion diagnostics for a range of targeted therapies. This kit is expected to fill the gap and marks a pioneering step in ChinaтАЩs precision oncology healthcare.

The kit uses advanced non-invasive liquid biopsy testing technology to accurately identify tumor-driving mutations by analyzing circulating tumor DNA (ctDNA) in the blood, without the need for tumor tissue samples. As a valuable complement to traditional tumor tissue testing, it greatly assists clinicians for timely treatment-decision making and drives personalized precision medicine.

Dr. Xiaonan Wang, CTO of Geneseeq, stated, тАЬThis kit is the third NGS IVD product from Geneseeq to enter the NMPA Innovative Medical Device program, following the previous NMPA approvals of the тАШEGFR/ALK/ROS1/BRAF/KRAS/HER2 Mutation Detection KitтАШ and the тАШGeneseeqPrime NGS TMB Testing KitтАШ for tumor tissue testing. From 6 genes to 400+ genes, from tumor tissue to liquid biopsy testing, Geneseeq has always been patient-need driven, continuously exploring the translation of cutting-edge technologies into clinical practice. The successful inclusion of this kit in the Innovative Medical Device program highlighted GeneseeqтАЩs R&D strength and innovation capability in the field of precision medicine. We believe that with the continuous technology innovation and clinical application, more and more patients will benefit from the technological advancements for life quality improvement.тАЭ

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CE-Marked GENESEEQ multi-cancer minimal residual disease detection (Shielding ULTRA MRD) and GENESEEQ multi-cancer early detection (CanScan MCED) kits introduced earlier this year

The GeneseeqPrime kit utilizes a set of 437 genes linked to solid tumors and the reportable range includes single nucleotide variants (SNVs), insertions and deletions (indels), copy number variants (CNVs), gene translocations and large genomic rearrangements (LGR), as well as tumor mutational burden (TMB), microsatellite instability (MSI), and DNA mismatch repair (MMR) genes. This test provides clinically relevant data that informs and guides therapeutic decisions. It offers crucial insights into pivotal oncogenic genes and possible mechanisms of drug resistance. Apart from the data provided by GeneseeqPrime, the GeneseeqPrime HRD report also incorporates the homologous recombination deficiency (HRD) status that can be used for recommendations in PARP inhibitor treatments. The Hemasalus DNA/Hemarna RNA investigates genetic variations and translocations in 475 genes at the DNA level, while also identifying translocations in 232 genes at the RNA level. This kit aids with clinical diagnosis and facilitates treatment planning for individuals afflicted by hematological malignancies.

тАЬThe CE Mark validation for the GeneseeqPrime, GeneseeqPrime HRD, and Hemasalus DNA/Hemarna RNA kits underscores our dedicationтАЩs commitment to high quality testing standards on a global level,тАЭ said┬аDr. Xue Wu, CEO of Geneseeq Canada. ┬аThe Geneseeq cancer genetic testing kit encompasses a comprehensive assay kit for sequencing, an automated reporting system, and a seamless end-to-end service that covers assay setup and customer support. These kits will now be accessible to healthcare professionals in Europe, enabling them to formulate treatment plans for individuals affected by cancer.

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