NEW YORK – Pillar Biosciences announced Thursday that its OncoReveal CDx pan-cancer test for solid tumors has received national coverage from the US Centers for Medicare and Medicaid Services.
The next-generation sequencing-based assay uses Pillar's proprietary Stem-Loop Inhibition-Mediated amplification (SLIMamp) technology to detect single nucleotide variants, insertions, and deletions in 22 genes using DNA isolated from formalin-fixed paraffin-embedded tumor tissue specimens. The test is intended to provide pan-cancer tumor mutation profiling for previously diagnosed cancer patients with solid malignant neoplasms, Pillar Biosciences said in a statement.
The test is also approved as a companion diagnostic to identify patients who might benefit from EGFR tyrosine kinase inhibitor therapy in non-small cell lung cancer and for Eli Lilly's Erbitux (cetuximab) and Amgen's Vectibix (panitumumab) for KRAS in colorectal cancer.
OncoReveal CDx was approved by the US Food and Drug Administration to run on Illumina's MiSeqDx instrument in 2024, Pillar noted. In 2023, Pillar and Illumina partnered to distribute Pillar's oncology tests globally as part of Illumina's cancer portfolio.
"In partnership with Illumina, we have enabled rapid and affordable FDA-approved NGS testing to be performed locally in any NGS lab," Pillar Chief Marketing Officer Brian Wright said in a statement. "With over 66 million people in the US covered by Medicare, this favorable decision will help ensure highly accurate, actionable, and reimbursable NGS testing is available to clinical laboratories and biopharmaceutical companies and enable faster treatment decisions and deliver improved outcomes that are accessible to everyone, everywhere."
Wright added that Pillar expects Medicare contractors to report their proposed pricing for the assay in Q2 2025. The test received the Proprietary Laboratory Analysis code 0523U in October.