Tempus xF Liquid Biopsy Assay Demonstrates Extensive Analytical and Clinical Validity in npj Precision Oncology Study

On July 12, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported results from validation studies demonstrating the reliable analytical performance of the Tempus|xF liquid biopsy (Press release, Tempus, JUL 12, 2021, View Source [SID1234584789]). When validated against methods such as ddPCR, the Roche AVENIO kit, and the Tempus|xT solid tumor assay, xF demonstrated high sensitivity and specificity for calling SNVs, indels, CNVs, and gene rearrangements, making the liquid biopsy next-generation sequencing assay a preferred sequencing option should tumor tissue not be available.

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xF is Tempus’ non-invasive, 105-gene liquid biopsy panel focused on oncogenic and resistance mutations in cell-free DNA. Designed to provide clinical decision support for solid tumors, xF is an alternative to tissue-based biopsies in identifying biomarkers, detecting resistant mutations, monitoring response to treatment or disease progression, and spotting early recurrence in real time. npj Precision Oncology published xF’s analytical validation, highlighting the assay’s high sensitivity and specificity for detecting single-nucleotide variants, insertions/deletions, copy number variants, and gene rearrangements. The validation results show high accuracy in detecting clinically-actionable targets compared to orthogonal testing methods.

"This study underscores the clinical value of liquid biopsies, a non-invasive sequencing option and another powerful tool for oncologists to determine clinically-actionable alterations necessary for highly-effective and personalized treatment options," said Dr. Kimberly Blackwell, Chief Medical Officer at Tempus. "At Tempus, we have also found that xF is especially beneficial when used in combination with standard tissue sequencing for patients with advanced cancer, and therefore it is important to offer oncologists both a liquid biopsy and solid tumor assay on a single platform."

xF is part of Tempus’ library of assays conducted in its CLIA-certified and CAP-accredited laboratory, which also includes xE, an assay that analyzes the whole exome and xT, an assay that analyzes 648 genes in solid tumor and hematologic malignancies.