Tempus receives FDA Premarket Approval for in vitro diagnostic scan
James Spargo | May 3, 2023 | News story | Medical Communications | Diagnostics, FDA, Oncology, Tempus, in vitro
US-based artificial intelligence (AI) and precision medicine company Tempus has announced that the US Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application for its companion diagnostic test xT CDx.
xT CDx is a 648-gene next-generation sequencing (NGS)-based in vitro diagnostic device which is used for solid tumour profiling, including microsatellite instability (MSI) status and companion diagnostic claims for colorectal cancer patients. It detects substitutions (single nucleotide variants [SNVs] and multi-nucleotide variants [MNVs]) and insertion and deletion alteratons (INDELs) using DNA isolated from matched normal blood or saliva samples from previously diagnosed patients with solid malignant neoplasms.
It is intended as a companion diagnostic (CDx) to identify potentially eligible patients for treatments listed in the Companion Diagnostic Indications table, and can also be used for providing tumour mutation profiling by qualified healthcare professionals.
Eric Lefkofsky, founder and CEO of Tempus, stated: “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. We designed xT CDx to be a smart test that can empower physicians to provide personalised care for their patients and support researchers in developing better therapeutics.”
James Spargo
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