Geneseeq Technology Inc. Received FDA 510(k) Clearance for GENESEEQPRIME® Assay
On September 02, 2025, Geneseeq Technology Inc. announced that the U.S. Food and Drug Administration (FDA) had granted 510(k) clearance for its GENESEEQPRIME® NGS Tumor Profiling Assay. This in vitro diagnostic (IVD) test kit used next-generation sequencing (NGS) to detect gene alterations in patients with solid malignant neoplasms.
The GENESEEQPRIME® assay was designed to interrogate 425 cancer-related genes and detect multiple types of genomic alterations, including single-nucleotide variants (SNVs), insertions/deletions (indels), and selected gene amplification and translocations....