Sam Brusco, Associate Editor05.02.23
Artificial intelligence (AI) and precision medicine company Tempus has earned U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its xT CDx companion diagnostic test.
xT CDx is a 684-gene, next-generation sequencing (NGS) test for solid tumor profiling, including microsatellite instability status and companion diagnostic claims for colorectal cancer patients.
"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 told the press. “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.”
Tempus’ comprehensive collection of intelligent diagnostics, clinical trial matching capabilities, and growing library of multimodal data can help support therapeutic innovation. The company aims to apply xT CDx to support CDx claims in further collaborations with biopharmaceutical companies. The companion diagnostics are built on the company’s proprietary platform.
xT CDx is a qualitative NGS-based in vitro diagnostic device intended to detect substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insert and delete alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using 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.
Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified healthcare professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms.
xT CDx is a 684-gene, next-generation sequencing (NGS) test for solid tumor profiling, including microsatellite instability status and companion diagnostic claims for colorectal cancer patients.
"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 told the press. “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.”
Tempus’ comprehensive collection of intelligent diagnostics, clinical trial matching capabilities, and growing library of multimodal data can help support therapeutic innovation. The company aims to apply xT CDx to support CDx claims in further collaborations with biopharmaceutical companies. The companion diagnostics are built on the company’s proprietary platform.
xT CDx is a qualitative NGS-based in vitro diagnostic device intended to detect substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insert and delete alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using 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.
Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified healthcare professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms.