Pillar Biosciences has secured a unique CPT® PLA code (0523U) from the American Medical Association (AMA) for its FDA-approved oncoReveal™ CDx pan-cancer IVD NGS kit. This advancement supports contract labs in providing comprehensive tumor profiling across multiple cancer types with ease and efficiency.
The oncoReveal™ CDx kit utilizes the proprietary SLIMamp (Stem-Loop Inhibition-Mediated Amplification) technology to detect clinically relevant mutations in DNA from FFPE tumor specimens, targeting single nucleotide variants (SNVs), insertions, and deletions in 22 genes commonly associated with solid tumors. With FDA clearance on the Illumina MiSeq™ Dx, this assay delivers reliable, actionable results that help guide targeted cancer treatments.
Benefits for Contract Laboratories
- Broad Clinical Utility: Provides mutation profiling across 22 cancer-associated genes, supporting multiple therapeutic decision pathways.
- Enhanced Reimbursement Opportunities: Unique CPT code facilitates reimbursement for contracted testing, expanding diagnostic service options.
- High Sensitivity with Proprietary SLIMamp Technology: Accurate detection of mutations for better-informed oncology decisions.
- Indication as Companion Diagnostic: Identifies candidates for EGFR TKI in NSCLC and KRAS therapies in colorectal cancer, adding therapeutic value.
- First Multi-Cancer FDA PMA-Approved Kit: Establishes credibility and compliance, attracting biopharma and clinical partnerships.
The oncoReveal™ CDx kit enables contract labs to offer local NGS-based diagnostics, improving speed, affordability, and precision in oncology testing.
This article is an AI generated summary of a published press release: “Pillar Biosciences Receives CPT® Code for FDA Approved oncoReveal™ CDx Pan-Cancer Solid tumor IVD Kit“
