GeneseeqPrime and GeneseeqPrime HRD are indicated for solid tumour genomic profiling while Hemasalus DNA/Hemarna RNA is approved for haematological cancer genomic profiling
Geneseeq gets CE Mark for three cancer test kits. (Credit: National Cancer Institute on Unsplash)
Geneseeq Technology has secured the European Union’s CE Mark approval for GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime HRD), GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus DNA/Hemarna RNA).
The Canada-based precision oncology company said that all three tests are next-generation sequencing (NGS)-based cancer genetic testing kits.
GeneseeqPrime and GeneseeqPrime HRD are indicated for solid tumour genomic profiling while Hemasalus DNA/Hemarna RNA is approved for haematological cancer genomic profiling.
According to Geneseeq Technology, the GeneseeqPrime kit uses a set of 437 genes that are associated with solid tumours. The reportable range consists of tumour mutational burden (TMB), microsatellite instability (MSI), and DNA mismatch repair (MMR) genes.
Additionally, the range includes single nucleotide variants (SNVs), insertions and deletions (indels), copy number variants (CNVs), and gene translocations and large genomic rearrangements (LGR).
It provides information on key oncogenic genes and potential drug resistance pathways to guide therapeutic decisions, the precision oncology company said.
In addition to the data offered by GeneseeqPrime, the GeneseeqPrime HRD report integrates the homologous recombination deficiency (HRD) status to suggest PARP inhibitor therapies.
The third test kit which received the CE Mark, which is Hemasalus DNA/Hemarna RNA, examines genetic variants and translocations in 475 genes at the DNA level. This is in addition to detecting translocations in 232 genes at the RNA level.
The kit is said to simplify clinical diagnosis and therapy planning for people with haematological malignancies.
Furthermore, the Geneseeq cancer genetic testing kit features an assay kit for sequencing, an automated reporting system, and an end-to-end service that includes assay setup and customer assistance.
Geneseeq Canada CEO Xue Wu said: “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.”
The Canadian company presently offers five CE-marked cancer genetic testing kits designed for different clinical scenarios.
Earlier this year, Geneseeq launched the CE-marked GENESEEQ multi-cancer minimal residual disease detection (Shielding ULTRA MRD) and GENESEEQ multi-cancer early detection (CanScan MCED) kits.