Tempus, a provider in artificial intelligence and precision medicine, announced that the U.S. Food & Drug Administration (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.

“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,” said Kate Sasser, PhD, Chief Scientific Officer of Tempus. “This Breakthrough Device Designation from the FDA recognizes 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 tumors, 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 optimize existing therapies and facilitate the advancement and implementation of novel and transformative treatments.”

Solid Tumor Diagnostics

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.

Further reading: FDA Approves VENTANA PD-L1 as a CDx for NSCLC Subtype