Tempus has received premarket approval from the US Food and Drug Administration (FDA) for its qualitative next-generation sequencing (NGS)-based in vitro diagnostic device, xT CDx.
The xT CDx device is designed to detect substitutions (single nucleotide variants and multi-nucleotide variants), as well as insertion and deletion alterations, in a set of 648 genes.
Additionally, it can determine the microsatellite instability status in the genes using DNA extracted from formalin-fixed paraffin-embedded tumour tissue specimens.
The test can also use DNA isolated from matched normal blood or saliva specimens obtained from cancer patients previously diagnosed with solid malignant neoplasms.
Tempus founder and CEO Eric Lefkofsky said: “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.”
The test also serves as a companion diagnostic (CDx) for the identification of patients who may find treatment with the targeted therapies listed in the Companion Diagnostic Indications table.
Furthermore, xT CDx offers tumour-mutation profiling for qualified healthcare professionals for the treatment of patients with previously diagnosed solid malignant neoplasms.
Tempus aims to leverage xT CDx to support CDx claims through additional collaborations with biopharmaceutical companies.
The company’s platform forms the foundation for these CDxs, offering a wide range of solutions for the development of novel drugs.
Additionally, it provides physicians with essential data to make informed decisions for the treatment of their patients.
