Research & Development
Tempus AI receives AMA PLA code for PurISTSM algorithmic test
8 July 2024 -

Tempus AI Inc (NASDAQ: TEM), a provider of artificial intelligence and precision medicine, announced on Monday that its PurISTSM algorithmic test received a proprietary laboratory analysis (PLA) code from the American Medical Association (AMA).

Effective from 1 October 2024, this marks the first common procedural terminology (CPT) code for an algorithm-only analysis based on previously-sequenced RNA data, facilitating reimbursement for AI-enabled algorithms.

PurISTSM identifies the molecular subtype of patients with unresectable stage III or IV pancreatic ductal adenocarcinoma (PDAC) using RNA profiling. The test classifies patients into basal or classical subtypes, aiding in first-line therapy management. A clinical validation study confirmed its efficacy in stratifying overall survival among classical patients treated with FOLFIRINOX or gemcitabine nab-paclitaxel.

RNA-based assays, including the new Category I CPT codes for RNA sequencing in solid tumours and hematolymphoid cancers, are gaining recognition for their clinical efficacy. Public and private payers increasingly deem RNA profiling medically necessary and reimbursable, with Medicare Administrative Contractor National Government Services and commercial payer Cigna listing the new RNA code as a covered test.

Tempus' RNA assay, xR, employs high-throughput hybridization-based capture technology to detect gene rearrangements and altered splicing in cancer patients. RNA sequencing provides significant clinical insights, as evidenced in various studies, enhancing patient matching to precision therapies and improving detection of oncogenic fusions.

On 27 June 2024, Tempus submitted its xR assay to the FDA for 510(k) premarket clearance, potentially qualifying for Advanced Diagnostic Laboratory Test status. PurISTSM is part of Tempus' AI-enabled test suite, which includes HRD, Tumor Origin, DPYD and UGT1A1, all leveraging sequencing data from xT and xR assays to enhance clinical utility.

Tempus aims to advance precision medicine through AI, offering solutions to physicians for personalised patient care and facilitating therapeutic discovery and development. According to the company, the new PLA code for PurISTSM could revolutionise reimbursement for clinically significant AI-driven insights.