FDA Bestows Breakthrough Device Designation Upon Tempus' Pioneering Hla-loh Companion Diagnostic Test

Tuesday, August 15, 2023

Tempus, a frontrunner in precision medicine and artificial intelligence, has marked a significant milestone: its groundbreaking HLA-LOH assay has earned Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA), serving as a pivotal companion diagnostic (CDx) test.

Leveraging the capabilities of machine learning, this assay interprets sequence data produced by Tempus' FDA-approved xT CDx assay, an innovative next-generation sequencing platform. Its core purpose lies in identifying cancer patients with solid tumors who stand to gain from targeted therapies personalized to their unique requirements. Particularly, this is pertinent when tumors display allele-specific loss of heterozygosity (LOH) linked to specific human leukocyte antigen (HLA) Class I alleles.

HLA-LOH introduces a distinct molecular differentiation between cancerous and non-cancerous cells, potentially acting as a critical biomarker to evaluate resistance to immune-based treatments. Tempus' HLA-LOH examination is finely tuned to accurately identify and dissect this biomarker, supplying crucial insights into patient responses to emerging medical interventions.

The FDA's acknowledgment of the Breakthrough Device Designation spotlights the revolutionary essence of Tempus' HLA-LOH assay and its potential influence on clinical practice. HLA-LOH holds significant promise, particularly within the realm of cell therapy for solid tumors, and broadens its scope to multiple precision medicine strategies in oncology, often in conjunction with established biomarkers.

Tempus is unwaveringly dedicated to refining the HLA-LOH assay for effective biomarker identification and analysis, aiming to enhance existing therapies and pave the way for novel treatment modalities. Given that solid tumors account for over 90% of annual cancer diagnoses in the U.S., frequently detected at advanced stages or accompanied by metastasis, treatment avenues are severely limited. Tempus' HLA-LOH test endeavors to bridge this gap by presenting targeted therapeutic pathways to address this pressing unmet need.

The FDA's Breakthrough Devices Program stands as a testament to advancing healthcare accessibility, ensuring that pioneering medical devices promptly reach patients to amplify the diagnosis and management of severe conditions. This initiative expedites the complete lifecycle of medical devices, spanning from development and evaluation to review, all while upholding the stringent benchmarks of safety and efficacy that define transformative strides in healthcare.

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