Tempus AI, Inc., a leader in artificial intelligence and precision medicine, announced that the Centers for Medicare & Medicaid Services (CMS) has granted Advanced Diagnostic Laboratory Test (ADLT) status for Tempus’ next-generation sequencing assay, xT CDx. xT CDx is the first Food and Drug Administration (FDA)-approved next-generation sequencing assay to perform matched normal sequence analysis to provide tumor mutation profiling for patients with solid organ neoplasms.
This CMS determination affirms that Tempus’ xT CDx meets the rigorous criteria for new ADLT status, which is reserved for novel products that provide new clinical diagnostic information that cannot be obtained any other way, or products cleared or approved by the FDA. The initial ADLT rate established by CMS is $4,500. During the nine-month period beginning July 1, 2024 and ending March 31, 2025, Tempus shall be reimbursed the established ADLT rate while it collects and submits to CMS the private payor payment amounts for xT CDx. Beginning April 1, 2025, CMS will establish a new Medicare rate based on the weighted median of private payer amounts.
“Since our inception, we have remained committed to expanding access to precision medicine solutions to all patients, and this designation is a significant milestone in our commitment to improving patient care through high-quality clinical laboratory testing,” said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. “We are grateful that CMS recognizes Tempus’ novel, high-quality approach to delivering physicians the molecular data necessary to improve patient outcomes.”
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xT CDx is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms.
The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling.
Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.
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.
Source: Businesswire
