with advanced cancer. FDA-cleared and CE-IVD-marked comprehensive tumor
profiling affords every patient access to personalized treatment options.
Product Features
- Trustworthy: FDA-cleared detection chemistry and CE-IVD-marked with overall clinical pass rate of 92.9%
- Fast: Results generated in less than a week via streamlined automation workflow and automated bioinformatics
- Actionable: 505 solid tumor-related genes, including all FDA-approved and professional guideline-supported biomarkers, with easy-to-interpret results
- Automated: On-site automation improves efficiency, consistency, and reduces human errors
Detection Chemistry Development & Validation
- Pan solid tumor: 35 solid tumor types across9 organ systems
- Robust: >7,300 analytical samples tested
- Rigorous: 15,000 hours of sequencing time
- Accurate: 13 orthogonal methods used for comparison, including PCR, IHC, FISH, RNA and DNA-based NGS approaches
Assay Specifications
| Sample requirements | FFPE Tissue, Slides, or Blocks |
| Tumor purity minimum | 20% |
| Regions analyzed | Coding regions of 505 genes; non-coding regions for translocations |
| Mutation Identification | MSI, TMB, Translocations , Indels, SNVs, & Amplifications |
| Read length | 2.23 Mb total |
| Average total coverage | 2,300x |
Sample Pathology Report
Comprehensive Anatomical Pathology
Our state-of-the-art anatomic laboratory is staffed by a team of board-certified pathologists who provide timely and expert interpretation across a range of subspecialties. We are proud to offer consultation services to ensure our physician partners receive the clarity and support needed to make critical treatment decisions with confidence.
Quantitative Polymerase Chain Reaction (qPCR)
Quantitative Polymerase Chain Reaction (qPCR) is a powerful, cost-effective, efficient, reliable, and rapid technology used in real-time to detect and quantify naturally occurring and mutated nucleic acids (DNA/RNA) present in a specimen. qPCR has widespread applications in clinical diagnostics.
Next-generation
Sequencing (NGS)
Next-Generation Sequencing (NGS) is a cutting-edge technology that is indispensable to providing the most accurate, complete, and tailored diagnostic information to clinicians for clinical care.
UTI – PCR Pathogen Identification & Resistance Gene Detection
We can detect bacteria in a higher number of symptomatic patients than with urine culture. PCR can also detect more polymicrobial infections compared to urine culture.