GeneRulor Achieves Full Marks in CAP Proficiency Testing and Earns Authoritative Recognition

Recently, the College of American Pathologists (CAP) released the evaluation report for the first half of 2025 PT program NGSST-A 2025. GeneRulor achieved an outstanding 100% concordance between its test results and the reference answers, earning a Good rating. This fully demonstrates the laboratory’s international-leading technical capability in NGS testing.

CAP NGSST-A 2025 Performance Transcript: GeneRulor Achieves Full Marks in the International “Big Exam”

CAP — The “Gold Standard” of International Medical Laboratories

The College of American Pathologists (CAP) is currently the largest organization of pathologists worldwide and is recognized as one of the most authoritative institutions for clinical laboratory accreditation. Its clinical laboratory quality certification programs are acknowledged globally as the “gold standard” in the industry.

NGSST is a CAP proficiency testing program specifically designed to assess laboratories’ capability in detecting solid tumor samples. It evaluates global genetic diagnostic laboratories using NGS technology to detect gene variants and perform annotation. The assessment covers the full workflow from laboratory operation, bioinformatics analysis, to result interpretation, imposing stringent requirements on sequencing technology and data analysis of participating institutions.

NGSST-A Project Overview

The NGSST-A project primarily targets solid tumor tissues and utilizes Next-Generation Sequencing (NGS) technology. The evaluation included three samples (NGSST-01 to NGSST-03) and tested key genes including KIT, KRAS, MET, PIK3CA, TP53, BRAF, ERBB2, NRAS, EGFR, IDH1, MAP2K1, covering mutation types such as single nucleotide variants (SNV) and insertions/deletions (Indel).

With its mature UMI liquid-phase hybrid capture technology, GeneRulor achieves a sensitivity of 0.01%, enabling ultra-precise genetic testing. Based on this core technology platform, we have successfully applied it to:

• AAV vector integration detection – precisely identifying vector integration sites in the genome and potential risks.

• Off-target validation via liquid-phase hybrid capture – high-sensitivity methods meeting FDA/CDE off-target site verification requirements.

• Whole-exome capture – comprehensive evaluation of genomic variations and studies on genetic stability.

• Pathogen detection including HPV and HBV – providing precise support for clinical diagnosis.

GeneRulor Quality Management System

GeneRulor has established a comprehensive multi-layered quality management and certification system:

• Successfully obtained ISO 9001 quality management system certification, establishing a standardized framework to ensure quality control across the full process from R&D to services.

• Achieved CNAS laboratory accreditation, receiving authoritative recognition of technical and management capabilities with full marks in the annual re-evaluation.

• Progressing toward the internationally recognized CAP medical laboratory certification, having successfully passed CAP proficiency testing and actively applying for formal CAP accreditation, aiming to reach the “gold standard” of global clinical laboratories.

This progressive quality system — from domestic standards to national recognition to top international certification — fully reflects our relentless pursuit of technical precision and service quality. Through the integration of multiple certifications, we provide the most reliable technical support for precision medicine and gene editing safety assessment.

Collaborative Progress Leading a New Era of Safety

GeneRulor will continue to uphold the management philosophy of “quality first”, continuously improving its quality management system to deliver higher-quality services and reports with greater efficiency, allowing more people to benefit from the achievements of precision medicine.

Looking ahead, the success in CAP proficiency testing serves as a new starting point for GeneRulor to deepen cooperation with top global research institutions, pharmaceutical companies, and clinical organizations, jointly establishing industry standards for gene editing safety assessment.

We will continue to refine our technology platform, expand testing capabilities, and provide more comprehensive and precise safety assurance for translating gene therapy from the laboratory to the clinic.

Let us work together to open a new era of gene editing safety evaluation with the strictest quality standards and cutting-edge technological innovation, contributing more to human health.