CMS has issued its final payment determination for Pillar Biosciences’ oncoReveal CDx, confirming a crosswalk-based national rate of $1,352.09, service beginning January 1, 2026. The decision, which aligns with CMS’ preliminary ruling from August, marks a meaningful advance for Medicare beneficiaries and reinforces oncoReveal CDx’s position as a front-line, multi-cancer NGS testing kit in the U.S. market.
For Pillar, the finalized pricing represents both reimbursement clarity and a significant commercial inflection point. OncoReveal CDx remains the first PMA-approved multi-cancer IVD kit available in the U.S., offering actionable, NGS-based results that support therapy selection across multiple tumor types. CMS’ determination provides a nationally stable rate that laboratories can plan around, removing reimbursement ambiguity that often slows adoption of new diagnostic kits. The company emphasized that the decision will accelerate beneficiary access across Medicare’s 66 million covered lives, a key driver for scaling precision oncology testing.
Pillar executives framed the ruling as a reinforcement of the company’s broader Decision Medicine strategy. CEO Gang Song noted that CMS’ confirmation underscores the kit’s clinical utility and quality, while the commercial team highlighted the broader market-opening effect for PMA diagnostics within oncology. With more than 20 NGS panels already available in IVD and RUO formats, and additional assays in development, the company is positioning oncoReveal CDx as a foundational component in a diversified testing portfolio powered by its SLIMamp and PiVAT technologies.
The pricing determination gives laboratories operational predictability heading into 2026, a year expected to bring high utilization of multi-cancer test panels driven by evolving therapy-selection standards, metastatic disease workflows, and payer pressure for accurate yet cost-efficient NGS solutions. For a kit structured around local-lab deployment and reduced cost of execution, the clarity of CMS’ national rate is likely to strengthen competitive positioning relative to centralized, higher-cost sequencing pathways.