Tempus today announced that the FDA has granted the company Breakthrough Device Designation for its HLA-LOH assay as a companion diagnostic (CDx) test. The test uses a machine learning model to analyze sequence data produced by Tempus’ FDA-approved, next generation sequencing-based xT CDx assay. It is intended to identify cancer patients with solid tumors who may benefit from treatment with specific targeted therapies when a patient’s tumor has experienced allele-specific loss of heterozygosity (LOH) for specific human leukocyte antigen (HLA) Class I alleles.
More than 90% of all yearly diagnosed cancers in U.S. patients comprise solid tumors. Many individuals afflicted by solid tumors receive late-stage diagnoses or encounter metastatic disease during relapse, leaving them with limited treatment options. Tempus’ HLA-LOH test is designed to identify an emerging biomarker that can help address the unmet need for better targeted therapies for these patients.
The FDA's Breakthrough Devices Program aims to provide healthcare providers and patients with timely access to medical devices that provide more effective diagnosis or treatment of serious conditions or diseases. This program accelerates the development, assessment, and review processes, while simultaneously upholding the necessary standards for safety and effectiveness.
