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Tempus Submits PMA Application for Tumor Profiling Assay to FDA

NEW YORK – Tempus said on Tuesday that it has submitted a premarket approval application for its next-generation sequencing-based xT-Onco tumor profiling assay to the US Food and Drug Administration.

The firm has submitted companion diagnostic claims, tumor profiling claims, and microsatellite instability status, using DNA isolated from formalin-fixed paraffin-embedded tumor tissue specimens, and matched normal specimens. Tempus will perform the assay at its lab in Chicago.

"Oncologists throughout the country leverage Tempus' sequencing assays to inform data-driven treatment decisions and deliver personalized patient care," Lauren Silvis, Tempus senior VP of regulatory affairs, said in a statement. "This regulatory milestone demonstrates our commitment to expanding the promise of precision medicine in oncology to more patients and providers."

The xT platform uses NGS to detect somatic single nucleotide variants, insertions, and deletions across 648 genes, as well as gene fusions using whole-transcriptome sequencing, and integrates the molecular data with structured patient clinical data.

Tempus received CE marking for the assay in November 2020.