CMS awards Tempus AI with ADLT status for xT CDx test

Tempus AI announced that the Centers for Medicare & Medicaid Serviceshas granted Advanced Diagnostic Laboratory Test status for Tempus’ next-generation sequencing assay, xT CDx. xT CDx is the first Food and Drug Administration-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.