Introduction
Caris MI Profile™ is a comprehensive tumour profiling platform designed to guide precision oncology. Through advanced whole exome sequencing (WES), whole transcriptome sequencing (WTS), and protein analysis, Caris MI Profile™ provides actionable insights that enables clinicians to identify most effective therapies and improve patient outcomes.
Caris MI Profile™ platform offers AI solutions such as Caris GPsai™ and Caris FOLFIRSTai™ to guide clinicians in diagnosis and treatment of cancer patients.
- GPSai™ is an AI-predictive algorithm cancer type similarity assessment functionality and is performed for Cancer of Unknown Primary (CUP) cases. It helps identify the tumour of origin by comparing molecular characteristics of patient’s tumour against 90 tumour categories in the Caris database with an accuracy of 94.8%.
- Caris FOLFIRSTai™ is a chemotherapy response predictor intended to gauge a metastatic colorectal cancer (mCRC) patient’s likelihood of benefit from first line FOLFOX+BV followed by FOLFIRI+BV, versus FOLFIRI+BV followed by FOLFOX+BV treatment.
Caris MI Profile™ offers a ‘’Look back’’ programme, that builds on the promise of personalised medicine by alerting ordering clinicians when a new drug or indication is approved that may provide previously profiled patients with a new treatment option(s).
By identifying genetic alterations, biomarkers and resistance mechanisms, Caris MI Profile™ offers an in-depth molecular analysis of tumours, thereby aiding in personalised treatment decisions.
DNA
Whole Exome Sequencing
(Mutations, Indels & Copy Number Alterations)
RNA
Whole Transcriptome Sequencing
(Fusions & Variant Transcripts)
Protein
Immunohistochemistry
Technical Information
The analysis covers DNA (SNVs, InDels, CNAs, viruses), RNA (gene fusions, expression, variant transcripts), and proteins (15+ tumour-specific antigens) using NGS, IHC, PyroSeq, and CISH. With whole exome (DNA) and transcriptome (RNA) sequencing, we analyze 23,000+ genes (1500x depth) and 17M RNA reads. We detect key alterations (e.g., fusions, CNAs) and genomic signatures (HRD, MSI, TMB). Clinical AI tools (Caris FOLFIRSTai™, GPSai™) and virus testing (HPV, EBV, MCPyV) enhance precision. Specimen requirements: 20% tumour (10 slides NGS only or 25 slides NGS+IHC).
| Technical Information | IHC | CISH | FISH |
|---|---|---|---|
| Sample Requirements (see requsition for full details) | 1 unstained slide at 4μm thickness from FFPE block, with evaluable tumour present, per IHC test | 1 unstained slide at 4μm thickness from FFPE block, with at least 100 evaluable tumour cells present, per CISH test | 2 unstained slides at 4μm thickness from FFPE block, with at least 100 evaluable cells present and 10% tumour, per FISH test |
| Sensitivity/Specificity | >95% | >95% | >95% |
| Technical Information | NGS (Whole Exome - DNA) | NGS (Whole Transcriptome - RNA) | |
|---|---|---|---|
| Sample Requirements | FFPE block or 10 unstained slides with a minimum of 20% malignant origin for DNA and 10% malignant origin for RNA. Needle biopsy is also acceptable (4-6 cores). | ||
| Tumour Enrichment (when necessary) | Microdissection to isolate and increase the number of cancer cells to improve test performance and increase the chance for successful testing from small tumour samples | ||
| Number of Genes | ~22,000 genes | ||
| Average Depth of Coverage (DNA) Average Read Count (RNA) | 1,000x for 720+ clinical and research genes and 400-500x for all other genes | 60 million | |
| Positive Percent Agreement (PPA) | > 95% for base substitutions at ≥ 5% mutant allele frequency; > 99% for indels at ≥ 5% mutant allele frequency; >95% for copy number alterations (amplifications ≥ 6 copies) | >97% | |
| Negative Percent Agreement (NPA) | >99% | ||
| Genomic and Transcriptomic Signatures and Panels | Microsatellite Instability (MSI) Tumor Mutational Burden (TMB) Loss of Heterozygosity (LOH) MI FOLFOXai™ * – AI predictor of FOLFOX response in metastatic colorectal adenocarcinoma | Human Leukocyte Antigen (HLA) Genotype* | |
| Genomic and Transcriptomic Signatures and Panels | MI GPSai™ * Genomic Prevalence Score – CUP, atypical presentation or clinical ambiguity cases | ||
Why choose Caris MI Profile™?
- Comprehensive Molecular Profiling:
- By analyzing DNA and RNA through WES and WTS, the platform offers a genomic and transcriptomic view of patient’s cancer.
- Incorporates protein analysis for tumour-relevant protein biomarkers.
- Personalized treatment:
- Matches patients with FDA-approved therapies, clinical trials, or off-label options by identifying clinically relevant biomarkers.
- Identifies resistance mechanisms to prevent the use of ineffective therapies.
- Advanced AI predictive algorithms:
- Caris GPsai™ is an AI-based cancer type similarity tool for CUP cases, identifying the tumour of origin with 94.8% accuracy.
- Caris FOLFIRSTai™ predicts chemotherapy response in metastatic colorectal cancer patients, guiding the optimal sequence of FOLFOX+BV and FOLFIRI+BV treatments.
- ‘’Look back’’ programme:
- The Caris MI Profile™ “Look Back” programme alerts clinicians when new drug approvals or indications offer previously profiled patients potential new treatment options.
- Extensive panel of biomarkers:
- A wide array of biomarkers is included, such as Microsatellite instability (MSI), tumour mutational burden (TMB), homologous recombination deficiency (HRD), and genomic loss of heterozygosity (gLOH).
Applications:
- Therapy selection: Finding treatments that are suited to a patient’s tumour characteristics
- Clinical trial matching: Using biomarker information to match individuals with suitable clinical studies.
- Resistance mechanism analysis: Identifying treatments that are likely to be ineffective.
- Cancer subtyping: Improving diagnostic accuracy and prognostic assessment.
How does Caris MI Profile™ work?
Caris MI Profile™ platform combines comprehensive molecular profiling of DNA, RNA, and proteins with advanced bioinformatics, providing clinicians with valuable insights to determine the most effective treatments, predicts resistance mechanisms, and tailor personalized treatment approaches for patients:
Research and Publications
Explore Caris Life Sciences’ latest research and clinical publications on precision oncology, molecular profiling and liquid biopsy by visiting Caris Life Sciences’ publications library.
