April 3, 2025—Pillar Biosciences announced it has received nationwide Medicare coverage by the Centers for Medicare and Medicaid Services for the OncoReveal CDx pan-cancer solid tumor in vitro diagnostic next-generation sequencing kit. OncoReveal CDx is an NGS-based IVD kit that uses the company’s proprietary stem-loop inhibition-mediated amplification, or SLIMamp, technology for detecting single nucleotide variants, insertions, and deletions in 22 genes using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens. The kit is intended to provide pan-cancer tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for previously diagnosed cancer patients with solid malignant neoplasms. OncoReveal CDx has been FDA cleared on the Illumina MiSeq Dx.
The company says it expects Medicare contractors to report their proposed pricing for OncoReveal CDx to the CMS in the second quarter of this year. The kit is reported to payers using the proprietary laboratory analysis CPT code 0523U.