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Geneseeq Nabs CE Marks for Cancer Test Kits

NEW YORK – Geneseeq Technology said Tuesday that it secured CE marking for two next-generation sequencing-based kits for solid tumor profiling and one NGS-based kit for hematological cancer genomic profiling.

The Toronto-based cancer detection firm said it received marketing clearances that will let it sell in Europe its GeneseeqPrime, GeneseeqPrime HRD, and Hemasalus DNA/Hemarna RNA kits.

"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," Geneseeq Canada CEO Xue Wu said in a statement. "These kits will now be accessible to healthcare professionals in Europe, enabling them to formulate treatment plans for individuals affected by cancer."

GeneseeqPrime is used to analyze 437 genes linked to solid tumors and detect single nucleotide variants, insertions and deletions, copy number variants, gene translocations and large genomic rearrangements, tumor mutational burden, microsatellite instability, and DNA mismatch repair genes. The results are used to guide therapeutic decisions through understanding of oncogenic genes and potential drug resistance, the firm said. GeneseeqPrime HRD is also used to analyze genomic alterations as well as homologous recombination deficiency-related genomic instability information that can help guide PARP-inhibitor treatments.

Hemasalus DNA/Hemarna RNA is used to identify genetic variations and translocations in 475 genes in DNA and translocations in 232 genes in RNA to aid diagnosis and treatment planning for patients with hematological malignancies.

In January, Geneseeq received CE marking for its multi-cancer minimal residual disease detection and multi-cancer early detection kits for use in solid tumor patients.