Research & Development
Tempus’ companion diagnostic test gains Breakthrough Device Designation from FDA
Tempus has announced that the US Food and Drug Administration (FDA) has granted it Breakthrough Device Designation for its HLA-LOH assay as a companion diagnostic (CDx) test.
The test utilises a machine learning model to enable it to analyse sequence data produced by Tempus’ FDA-approved, next-generation sequencing-based xT CDx assay. This technology is intended to identify cancer patients with solid tumours who may benefit from specific targeted therapies when the patient’s tumour has experienced allele-specific loss of heterozygosity (LOH) for specific human leukocyte antigen (HLA) class 1 alleles.
“HLA-LOH provides a clear molecular distinction between cancer and non-cancer cells and is a potential biomarker for immune therapy resistance. The Tempus HLA-LOH test is intended to measure this biomarker and better understand which patients may respond to new therapies,” stated Kate Sasser PhD, chief scientific officer of Tempus. “This Breakthrough Device Designation from the FDA recognises the novelty and potential clinical impact of our HLA-LOH test for this promising biomarker. HLA-LOH is of special interest for the application of cell therapy to treat solid tumours, but also has broader potential for other precision medicine approaches in oncology, including in combination with other established biomarkers. The Tempus test is being developed to identify HLA-LOH and may help optimise existing therapies and facilitate the advancement and implementation of novel and transformative treatments.”