Pillar Biosciences Secures U.S. Nationwide Medicare Coverage for oncoReveal® CDx Pan-Cancer NGS Kit
04 April 2025 | Friday | News
Pillar Biosciences, Inc., the leader in Decision Medicine™, announced they have received nationwide Medicare coverage by the Centers for Medicare & Medicaid Services (CMS) for oncoReveal® CDx pan-cancer solid tumor in vitro diagnostic (IVD) NGS kit.
oncoReveal® CDx is a NGS based IVD kit that uses Pillar's proprietary SLIMamp (Stem-Loop Inhibition-Mediated amplification) technology for detection of single nucleotide variants (SNVs), insertions and deletions in 22 genes using DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. The oncoReveal® CDx IVD 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. Additionally, oncoReveal® CDx has also been approved as a companion diagnostic to identify patients who may benefit from EGFR TKI therapy (class approval) in NSCLC and ERBITUX® and VECTIBIX® for KRAS in CRC. oncoReveal® CDx has been FDA cleared on the Illumina MiSeq™ Dx. The oncoReveal® CDx IVD is reported to payers using the Proprietary Laboratory Analysis CPT code 0523U.
"Next generation sequencing holds profound promise to change the course of disease for so many cancer patients, but only if it is accessible," said Traci Pawlowski, Vice President and Head of Clinical Solutions at Illumina. "We are proud to partner with leaders like Pillar Biosciences to make genomic testing more accessible and affordable, so that more patients can benefit from targeted therapy breakthroughs."
"This is an important and exciting milestone in the launch of oncoReveal® CDx for Pillar," said Brian Wright, Chief Marketing Officer of Pillar Biosciences. "In partnership with Illumina, we have enabled rapid and affordable FDA approved NGS testing to be performed locally in any NGS lab. 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. We expect Medicare contractors to report their proposed pricing for oncoReveal® CDx to CMS in Q2 of this year."
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Pillar Biosciences, Inc., the leader in Decision Medicine™, announced they have received nationwide Medicare coverage by the Centers for Medicare & Medicaid Services (CMS) for oncoReveal® CDx pan-cancer solid tumor in vitro diagnostic (IVD) NGS kit.
oncoReveal® CDx is a NGS based IVD kit that uses Pillar's proprietary SLIMamp (Stem-Loop Inhibition-Mediated amplification) technology for detection of single nucleotide variants (SNVs), insertions and deletions in 22 genes using DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. The oncoReveal® CDx IVD 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. Additionally, oncoReveal® CDx has also been approved as a companion diagnostic to identify patients who may benefit from EGFR TKI therapy (class approval) in NSCLC and ERBITUX® and VECTIBIX® for KRAS in CRC. oncoReveal® CDx has been FDA cleared on the Illumina MiSeq™ Dx. The oncoReveal® CDx IVD is reported to payers using the Proprietary Laboratory Analysis CPT code 0523U.
"Next generation sequencing holds profound promise to change the course of disease for so many cancer patients, but only if it is accessible," said Traci Pawlowski, Vice President and Head of Clinical Solutions at Illumina. "We are proud to partner with leaders like Pillar Biosciences to make genomic testing more accessible and affordable, so that more patients can benefit from targeted therapy breakthroughs."
"This is an important and exciting milestone in the launch of oncoReveal® CDx for Pillar," said Brian Wright, Chief Marketing Officer of Pillar Biosciences. "In partnership with Illumina, we have enabled rapid and affordable FDA approved NGS testing to be performed locally in any NGS lab. 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. We expect Medicare contractors to report their proposed pricing for oncoReveal® CDx to CMS in Q2 of this year."
