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Geneseeq Gains CE Marks for NGS-based Test Kits for Solid Tumors and Hematological Cancer

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Summation

  • 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.
  • 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.
  • has announced that three of our next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime ™), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime™ HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus™ DNA/Hemarna™ RNA), have obtained the European Union’s CE Mark approval.

Geneseeq Technology Inc. has announced that three of our next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime ™), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime™ HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus™ DNA/Hemarna™ RNA), have obtained the European Union’s CE Mark approval. These approvals signify that GeneseeqPrime™ and GeneseeqPrime™ HRD are suitable for solid tumor genomic profiling, while Hemasalus™ DNA/Hemarna™ RNA is cleared for hematological cancer genomic profiling. In addition to the 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, Geneseeq currently offers five CE-marked cancer genetic testing kits tailored for various clinical situations.

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.

“The CE Mark validation for the GeneseeqPrime™, GeneseeqPrime™ HRD, and Hemasalus™ DNA/Hemarna™ RNA kits underscores our dedication’s commitment to high quality testing standards on a global level,” said Dr. Xue Wu, CEO of Geneseeq Canada. The 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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