MI Profile Tissue-based Profiling
Caris MI Profile
Caris MI Profile™ comprehensive testing delivers whole exome sequencing (WES – DNA) and whole transcriptome sequencing (WTS – RNA) for 23,000+ genes, as well as protein analysis and AI-predictive algorithms. Testing is designed to reveal a complete molecular blueprint that can guide more precise and individualized treatment decisions to help improve patient outcomes. The results also include AI signatures Caris GPSai (CUP cases) and Caris FOLFIRSTai (mCRC cases) to help confirm diagnosis and improve therapy selection.
This comprehensive testing provides actionable results to guide clinical decisions in easy-to-interpret report:
- Results with Therapy Associations – Easy to understand biomarker-therapy associations specific to your patient.
- Biomarker Levels – Drug associations with level of evidence:
- Level 1 – Biomarker test noted in FDA indication
- Level 2 – Endorsed by clinical guidelines
- Level 3 – Evidence exists in patient’s tumor type
- Therapies with Potential Benefit/Lack of Benefit – Therapies with potential benefit are noted in green while lack of benefit is noted in red.
- Important Notes – Significant information about drug/biomarker associations and comments from Caris pathologists and molecular geneticists, if applicable.
- Cancer-Type Relevant Biomarkers – Pre-defined biomarkers whose results will show regardless of presence or absence of an alteration.
- Clinical Trials – Clinical trial information, including Right-In-Time Clinical Trials, can be found in the report.
SPECIMEN TYPE(S)
Tissue (FFPE)
Tissue (Fresh)
APPLICATION
Profiling for therapy selection
DOCUMENT DOWNLOADS
The Most Comprehensive Molecular Profiling Available
TECHNOLOGY
Next-generation sequencing (NGS), IHC, CISH, PyroSeq
APPLICATION
Biomarker Analysis
BIOLOGICAL COVERAGE
Tissue (Fresh or FFPE)
MOLECULAR AI
Caris FOLFIRSTai (mCRC cases)
Caris GPSai (CUP cases)
GENES & DEPTH
23,000+ | 1,500x for clinical genes (DNA)
23,000+ | 17 million reads (RNA)
Next generation sequencing
Whole exome
Whole transcriptome
Alterations
SNVs, InDels, CNAs, Karyotyping, Viruses
Genomic Signatures / Other
gLOH, HRD, MSI, TMB, HLA Genotyping
Sample Quantity
≥20% tumor nuclei from FFPE block, unstained slides, core needle biopsy, fine needle aspirate, malignant fluid cell block, bone / bone metastasis.
Submit in 10% neutral buffered formalin from fresh tissue, core needle biopsy, bone / bone metastasis.
Performance
PPA
(DNA)
>97% for base substitutions at ≥ 5% mutant allele frequency;
>97% for indels at ≥ 5% mutant allele frequency;
>95% for copy number alterations (amplifications ≥ 6 copies)
(RNA)
>96% (all variants)
NPA
(DNA)
>99%
(RNA)
>99%
Actionable Insights from Tissue
Caris MI Profile comprehensive testing delivers whole exome sequencing (WES – DNA) and whole transcriptome sequencing (WTS – RNA) of 23,000+ genes, as well as protein analysis and predictive AI algorithms. The test is designed to reveal a more complete molecular blueprint that can guide precise and individualized treatment decisions to help improve patient outcomes.
Immunohistochemistry (IHC)
15+ tumor expressed proteins
Including CLDN18, HER2, FOLR1, MMR, PD-L1 (22c3, 28-8, SP142, SP263) and others
Order Profiling
Email the completed form(s) to CustomerSupport@CarisLS.com, or fax to 1.866.479.4925. When specimen is being prepared for shipment, please include completed forms with the shipper.
*Excluding EEA, EU, CH countries.
Tour Our Tissue Lab
Caris+Portal
Convenient Access to Caris Profiling
Caris+™Portal provides easy access for users to electronically submit orders, track case progress, view results and review Caris Life Sciences’ profiling information in one convenient location.
New users will select the Register link at the bottom of the login page and enter their name and their clinic or institution email address to verify the account.
Complete Molecular Intelligence Report
The Caris Molecular Profiling Report delivers high impact results, including potentially relevant, actionable clinical information, in an easy-to-interpret format. Every report includes access to the MI Portal and the Clinical Trials Connector™, which matches each patient’s unique biomarker expression profile to open, pertinent clinical trial opportunities.
| Technical Info | IHC | CISH |
|---|---|---|
| Sample Requirements
(see requisition for full details) | 1 unstained slide at 4μm thickness from FFPE block, with evaluable tumor present, per IHC test | 1 unstained slide at 4μm thickness from FFPE block, with at least 100 evaluable tumor cells present, per CISH test |
| Sensitivity/Specificity | >95% | >95% |
| Technical Info | NGS (WHOLE EXOME – DNA) | NGS (WHOLE TRANSCRIPTOME – RNA) |
|---|---|---|
| Sample Requirements | ≥20% tumor nuclei. Accepted specimen types: FFPE block, unstained slides, core needle biopsy, fine needle aspirate, malignant fluid cell block, bone/bone metastasis. See Tumor Profiling Requisition for complete details. | |
| Tumor 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 tumor samples | |
| Number of Genes | 23,000+ genes | 23,000+ genes |
| Average Depth of Coverage (DNA) Average Read Count (RNA) | 1,500x for clinical genes | 17 million reads |
| Positive Percent Agreement (PPA) | >97% for base substitutions at ≥ 5% mutant allele frequency; >97% for indels at ≥ 5% mutant allele frequency; >95% for copy number alterations (amplifications ≥ 6 copies) | >96% |
| Negative Percent Agreement (NPA) | >99% | >99% |
| Alterations | SNVs, Indels, CNAs, Karyotyping, Viruses | Gene Fusions and Variant Transcripts |
| Viruses | HPV 16 & 18 (Head & Neck, Anal, Genital, CUP)
EBV (Head & Neck, Esophagogastric Junction, Gastric Adenocarcinoma, CUP. If positive result in cancer type not listed here, EBER ISH reflex to confirm EBV result) MCPyV (Merkel Cell, Neuroendocrine – Poorly Differentiated (High-Grade)/Large or Small Cell Carcinoma, CUP) | |
| Genomic Signatures/Other | Genomic Loss of Heterozygosity (gLOH), Homologous Recombination Deficiency (HRD), Microsatellite Instability (MSI),
Tumor Mutational Burden (TMB), Human Leukocyte Antigen (HLA) Genotype Caris FOLFIRSTaiTM Caris GPSaiTM | |
Discover
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Caris has amassed an industry leading database of molecular and clinical data with more than 550,000 matched patient records. This data enables novel molecular signatures to help improve patient outcomes.
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