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

Related Content

FDA approves first oral antiviral to treat adult patients with COVID-19

The US Food and Drug Administration (FDA) has announced that it has approved the oral …

ZOLL remedē System receives FDA approval for sleep apnoea treatment

ZOLL Medical Corporation has announced that it has received approval from the US Food and …

Artivion receives FDA PMA approval of PerClot; transfers designation to Baxter

US cardiac and vascular surgery company Artivion has announced that the US Food and Drug …

Latest content