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NPJ Precision Oncology Publishes Tempus Study on Validation of its HLA-LOH Investigational Assay
CHICAGO--(BUSINESS WIRE)-- Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care,
About this update from Tempus Ai, Inc.
[{"type":"text","content":" CHICAGO--(BUSINESS WIRE)--\nTempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced that the validation study of its human leukocyte antigen (HLA) loss of heterozygosity (LOH) investigational assay has been published in npj Precision Oncology. Titled, “Detecting HLA loss of heterozygosity within a standard diagnostic sequencing workflow for prognostic and therapeutic opportunities,” the study included analytical validation of an investigational test that detects HLA-LOH based on analysis of data generated from Tempus’ FDA-approved, next generation sequencing-based xT CDx assay. The test uses a machine learning model to analyze sequenced data produced by Tempus’ xT CDx assay to identify patients with solid tumors that have experienced allele-specific LOH for specific HLA Class I alleles and may benefit from treatment with specific, targeted therapies.\n\n\nThe study evaluated the test’s ability to accurately detect HLA-LOH in clinical samples with >=40% tumor cells. In collaboration with A2 Biotherapeutics, Tempus analyzed data from an observational clinical trial (NCT04981119), and demonstrated the feasibility of identifying HLA-LOH patients and accruing them into prospective studies by leveraging analysis of routinely obtained clinical diagnostic data. Results support the assay's use as an investigational device for precision oncology clinical trial use.\n\n\n“Tempus’ HLA-LOH test is particularly significant for use in clinical trials that apply cell therapy to solid tumors, and it also has wider implications for precision medicine, including its use alongside other established biomarkers,” said Kate Sasser, PhD, Chief Scientific Officer at Tempus. “As validated in this study, the HLA-LOH test may help identify patients most likely to benefit from new and exciting therapies.”\n\n\nIn 2023, the U.S. Food & Drug Administration (FDA) granted Breakthrough Device Designation for the use of Tempus’ HLA-LOH assay as a companion diagnostic test. The HLA-LOH assay is an investigational device that is not currently available for clinical use.\n\n\nAbout Tempus\n\n\nTempus 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 multimod...