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Tempus Nabs CMS Advanced Diagnostic Laboratory Test Status for Tumor Mutation Profiling Test

NEW YORK – Cancer genomics firm Tempus AI said Tuesday that the Centers for Medicare and Medicaid Services has granted Advanced Diagnostic Laboratory Test status for a molecular assay that is used for tumor mutation profiling of patients with solid organ neoplasms.

The Chicago-based firm's xT CDx is a next-generation sequencing-based assay that is used for the detection of substitutions, insertions, and deletions in 648 genes and microsatellite instability status in DNA that is isolated from formalin-fixed paraffin-embedded tumor tissue specimens or matched normal blood or saliva specimens from patients who have solid malignant neoplasms. The results are used to identify patients who are likely to benefit from targeted therapies as well as to provide tumor mutation profiling.

The firm said that CMS has established a reimbursement rate of $4,500 for the next nine months, ending March 31, 2025. Tempus will collect and submit to the CMS the private payor payment amounts for the assay, and the CMS will establish a new Medicare rate on April 1, 2025, based on the weighted median reimbursement amounts from private payors.

Tempus noted that the Advanced Diagnostic Laboratory Test designation is used to identify novel products that provide new clinical information that cannot be obtained from other products that have been cleared or approved by the US Food and Drug Administration.

"We are grateful that CMS recognizes Tempus’ novel, high-quality approach to delivering physicians the molecular data necessary to improve patient outcomes," Tempus Chief Medical Officer Ezra Cohen said in a statement.

Tempus priced last month its initial public offering, through which the firm expects gross proceeds of $410.7 million. The firm's flagship product is its Tempus Platform, which is used to collect and use healthcare data for oncology. However, Guardant Health also filed last month a federal lawsuit accusing Tempus AI of infringing patents related to liquid biopsy sequencing methods.