Innovation & TechTempus' xT CDx Achieves Breakthrough Designation as First ADLT for Tumor Mutation...

Tempus’ xT CDx Achieves Breakthrough Designation as First ADLT for Tumor Mutation Profiling

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July 2024- Tempus 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.

Also Read: Good News! Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a)

“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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