FDA Approves 648-Gene Sequencing Test for Solid Tumor Profiling

Tempus has received its first premarket approval from the FDA for its xT CDx, a 648-gene next-generation sequencing test for molecular profiling of all solid malignant tumors.

xT CDx is also intended as a companion diagnostic to identify colorectal cancer patients who may benefit from treatment with certain targeted therapies.

The test uses DNA isolated from tumors and matches that DNA with DNA isolated from normal blood or saliva specimens from previously diagnosed cancer patients.

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