Therapy Areas: Devices
FDA Grants Breakthrough Device Designation to Tempus' HLA-LOH Companion Diagnostic Test
21 August 2023 - - The US Food & Drug Administration has granted US-based artificial intelligence and precision medicine company Tempus Breakthrough Device Designation for its HLA-LOH assay as a companion diagnostic test, the company said.

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 for specific human leukocyte antigen Class I alleles.

More than 90% of all yearly diagnosed cancers in US 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.

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare.

With one of the world's largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics.

The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data.