Tempus granted FDA premarket approval for colorectal cancer CDx

Tempus on Monday announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for its xT CDx sequencing test as a companion diagnostic.

xT CDx is a 648-gene next-generation sequencing test (NGS) for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients.

The NGS test detects substitutions — single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs) and insertion and deletion alterations (INDELs) — in 648 genes, as well as microsatellite instability (MSI) status. It uses DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens and DNA isolated from matched normal blood or saliva specimens from previously diagnosed cancer patients with solid malignant neoplasms.

“This is a significant milestone for Tempus as we continue to establish a regulatory pathway for our platform, which offers solutions to advance both clinical care and support cutting-edge research,” Eric Lefkofsky, founder and CEO of Tempus, said in a statement. “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.”

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