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Tempus Gains FDA Premarket Approval for NGS Solid Tumor Profiling Test

NEW YORK – Tempus said Monday that the US Food and Drug Administration has given premarket approval for the firm's companion diagnostic test for colorectal cancer treatment.

Chicago-based Tempus' xT CDx is a 648-gene next-generation sequencing test that can be used to provide solid tumor profiling in cancer patients with solid malignant neoplasms. It detects single- and multi-nucleotide variants, insertions, and deletions and microsatellite instability status from formalin-fixed, paraffin-embedded tumor tissue specimens and DNA isolated from matched normal blood or saliva specimens.

The test is intended as a companion diagnostic that could help identify which patients would benefit from treatment with targeted therapies. It is performed at Tempus' facility in Chicago.

Tempus CEO Eric Lefkofsky said in a statement that the premarket approval is a significant milestone for the company as it tries to establish a regulatory pathway for its testing platform, "which offers solutions to advance both clinical care and support cutting-edge research. We designed xT CDx to be a smart test that can empower physicians to provide personalized care for their patients and support researchers in developing better therapeutics," he said.