MI Cancer Seek
The First and Only Simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based Assay with FDA-Approved CDx Indications for Molecular Profiling of Solid Tumors
#1 most-ordered
Comprehensive tissue-profiling test
6-9 days
Average testing turnaround time upon specimen receipt
23,000+ genes
Simultaneously analyzed using WES + WTS
3,100+ Locations
Integrated via EHR ordering
<$100 USD
Typical patient out-of-pocket cost
What it is:
MI Cancer Seek® analyzes 23,000+ genes through simultaneous WES/WTS Sequencing of DNA and RNA from a single tissue sample.
Not available in all locations.
Why it matters:
The result is a complete molecular blueprint that empowers clinicians to make more informed personalized therapy decisions for adult and pediatric patients with advanced solid tumors.
MI Cancer Seek
Designed for patients with
solid tumor cancers
Eligible patients:
- Patients with previously diagnosed malignant solid tumors
- Adult and pediatric patients with advanced or metastatic disease
Patients who may benefit from targeted therapies, include patients with:
TESTING WORKFLOW
How MI Cancer Seek Works
MI Cancer Seek is authorized as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed below.
Tumor Tissue Collected
A tissue sample is collected during a biopsy or surgical removal of your tumor.
DNA and RNA Sequencing Performed
Simultaneous WES/WTS delivers a more complete picture of the biomarkers driving your cancer.
Genomic Alterations Identified
Advanced bioinformatics identify clinically relevant genomic alterations and molecular signatures from DNA and RNA sequencing data.
Clinical Report Delivered
Results are delivered to the ordering physician within 6-9 days of specimen receipt, providing molecular insights to help personalize treatment based on the patient’s distinct cancer.
Test results
Easy-to-Interpret Results to Guide Treatment
Treatment Planning
- Identify FDA-approved therapies with potential benefit
- Flag therapies that may not help
- Match patients to clinical trials based on tumor biology
EHR-Compatible
- Real-time sync
- HITECH compliant
- Secure encryption
Evidence-Guided
- Drug associations based on peer-reviewed literature and clinical treatment guidelines
- Testing methodologies consistent with industry guidelines
FDA-Approved CDx Indications
Biomarker to Therapy
MI Cancer Seek is authorized as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed below.
Colorectal Cancer
IF BIOMARKER
KRAS wild-type (absence of mutations in exons 2, 3, and 4) and
NRAS wild-type (absence of mutations in exons 2, 3, and 4)
VECTIBIX® · panitumumab
IF BIOMARKER
BRAF V600E
BRAFTOVI® · encorafenib
in combination with ERBITUX® (cetuximab)
Breast Cancer
IF BIOMARKER
PIK3CA mutations (C420R; E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y)
PIQRAY® · alpelisib
Melanoma
IF BIOMARKER
BRAF V600E
BRAF inhibitors · FDA-approved
* see FDA-approved list
IF BIOMARKER
BRAF V600E or V600K
MEKINIST® · trametinib
or BRAF/MEK inhibitor combinations approved by FDA
* see FDA-approved list
Solid Tumors
IF BIOMARKER
MSI-H
KEYTRUDA® (pembrolizumab),
JEMPERLI® (dostarlimab-gxly)
Non-small cell lung cancer (NSCLC)
IF BIOMARKER
EGFR exon 19 deletions and exon
21 L858R alterations
EGFR Tyrosine Kinase Inhibitors approved by FDA*
Endometrial Carcinoma
IF BIOMARKER
NOT MSI-H
KEYTRUDA® · (pembrolizumab)
in combination with LENVIMA® (lenvatinib)
A Comprehensive Approach
The Difference Adds Up
FDA-APPROVED CDX INDICATIONS
(Tumor Type – Biomarker)
- Breast Cancer – PIK3CA
- CRC– KRAS wt, NRAS wt, BRAF V600E
- Melanoma – BRAF V600E, BRAF V600K
- NSCLC – EGFR exon 19 deletions and exon21 L858R alterations
- Solid Tumors – MSI-H
- Endometrial Carcinoma – Not MSI-H
MI CANCER SEEK PLATFORM FEATURES
- WES/WTS
- 23,000+ genes sequenced
- Comprehensive results
PROFESSIONAL SERVICES
(Included with the MI Cancer Seek Test)
- Features by WES – gLOH, HRD, HLA Genotype, Chromosomal alterations, Viruses
- Features by WTS – Expression, Fusions, Transcripts
- AI Signatures – GPSai, FOLFIRSTai
AVAILABLE ADD-ON TESTING & ADDITIONAL FEATURES
- IHCs – 25+ Tumor-specific proteins
- ISH – EBER
- Pyrosequencing – MGMT Methylation
- Look-Back Program
- Quick Turnaround Time (6-9 days)
- COSMIC Mutational Signatures
AFFORDABILITY
Financial Flexibility for Patients
At Caris, we believe cancer testing should be accessible to everyone. Our team is ready to support you with any insurance or billing questions.
Many patients don’t realize
- If you are uninsured or worried about cost, we offer financial assistance programs to help eligible patients get the testing they need without added stress.
- Caris maintains in-network coverage with most major commercial payers nationwide, including national coverage through Medicare and Medicare Advantage. Qualifying Medicare/Medicaid patients have no out-of-pocket responsibility.
- Most patients will be responsible for less than $100 USD out-of-pocket, including co-pays, co-insurance and deductibles. If your invoice is $100 USD or more, Caris will call you to discuss financial assistance options.
Publication Highlight
Clinical and analytical validation of MI Cancer Seek®, a companion diagnostic whole exome and whole transcriptome sequencing-based comprehensive molecular profiling assay
Specimen Requirements
Sample and Laboratory Specifications
Specimen Type
FFPE Tumor Tissue
Minimum Input
≥50 ng DNA from extracted tumor nucleic acid
Variant Coverage
- SNVs
- InDels
- CNAs
- Genomic Signatures: MSI, TMB
Document Downloads
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. Not available in all locations.
Important Note
Scope of MI Cancer
Seek Label
The content of this page contains references to some offerings that do not have FDA CDx approvals but are
included in the MI Cancer Seek test result from WES/WTS hybrid tissue NGS platform. In interacting with
customers, avoid inferring that all available services are FDA-approved. See table below for a summary of
services in and out of scope of FDA-approved labeling for MI Cancer Seek.
- SNVs, InDels in 228 genes (as listed in the MCS labeling)
- Microsatellite Instability (MSI)
- Tumor Mutational Burden (TMB)
- Copy Number Alteration (CNA) in one gene in patient with breast cancer
- 8 Companion Diagnostic (CDx) Indications
- Remainder of reportable genes
- gLOH, HRD, HLA Genotype, Chromosomal alterations, Viruses
- Expression, Fusions, Variant transcripts
- AI Signatures, e.g. Caris GPSai, Caris FOLFIRSTai
*For the most current information about the device indications for the therapeutic products in this group, go to:
https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools#Group_Labeling
PIQRAY® is a registered trademark of Novartis AG. VECTIBIX® is a registered trademark of Immunex Corporation. BRAFTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various other countries. ERBITUX® is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. MEKINIST® is a registered trademark of Novartis AG Corporation Switzerland. KEYTRUDA® is a registered trademark of Merck. JEMPERLI® (dostarlimab-gxly) is a registered trademark owned by the GSK group of companies. LENVIMA® (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
Next Steps
MI Cancer Seek
