We're proud to announce that the U.S. Food and Drug Administration (FDA) has granted approval for a tumor-only indication for our xT CDx next-generation sequencing platform. With this expanded label, Tempus is the first laboratory to hold FDA companion diagnostic (CDx) approval for both tumor-only and tumor-normal comprehensive genomic profiling.
Read on:
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*xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes in patients with previously diagnosed solid malignant neoplasms. The assay uses DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens and, when available, patient-matched blood or saliva specimens. Additionally, the device detects microsatellite instability (MSI) status based on a genomic signature from the tumor specimen only. The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.