MI Cancer Seek Tumor Profiling
MI Cancer Seek
MI Cancer Seek™ is 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. MI Cancer Seek is available for adult and pediatric (ages 1-22) patients.
FDA-Approved CDx Indications and Tumor Profiling
MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic device using total nucleic acid (TNA) isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the detection of SNVs, InDels, MSI, TMB in patients with previously diagnosed solid tumors, and CNA in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table, in accordance with the approved therapeutic product labeling.
Additional Services
Beyond the MI Cancer Seek FDA-approved indications, additional sequencing-based features are reported.
- DNA: gLOH, HRD, HLA Genotype, Chromosomal Alterations, Viruses (HPV 16 & 18, EBV, MCPyV)
- RNA: Expression, Fusions, Variant Transcripts
- AI Signatures: Caris GPSai™, Caris FOLFIRSTai™
MI Cancer Seek will be available for clinical ordering soon.
SPECIMEN TYPE
Tissue (FFPE)
APPLICATION
Solid tumor profiling for therapy selection
DOCUMENT DOWNLOADS
MI Cancer Seek Companion Diagnostic Indications
Indication |
Biomarker |
Therapy |
Breast Cancer |
PIK3CA (C420R; E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y) |
PIQRAY® (alpelisib) |
Colorectal Cancer (CRC) |
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) |
|
BRAF V600E |
BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab) |
Melanoma |
BRAF V600E |
BRAF inhibitors approved by FDA* |
|
BRAF V600E or V600K |
MEKINIST® (trametinib) or BRAF/MEK inhibitor combinations approved by FDA* |
Non-Small Cell Lung Cancer (NSCLC) |
EGFR exon 19 deletions and exon 21 L858R alterations |
EGFR Tyrosine Kinase Inhibitors approved by FDA* |
Solid Tumors |
MSI-H |
KEYTRUDA® (pembrolizumab), JEMPERLI (dostarlimab-gxly) |
Endometrial Carcinoma |
Not MSI-H |
KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib) |
*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. LENVIMA® (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
MI Cancer Seek - Technical Specifications and Performance
TECHNOLOGY
Next-generation sequencing of total nucleic acids
VARIANT COVERAGE
Somatic Tumor:
SNVs InDels CNAs
GENOMIC SIGNATURES
MSI TMB
SPECIMEN QUANTITY†
≥50ng of total nucleic acid
(~10 slides at 20% tumor nuclei)
BREAST |
PIK3CA | PPA: 99.4% |
| NPA: 100% | ||
CRC |
KRAS & NRAS Wild-type |
PPA: 100% |
| NPA: 97.2% | ||
| BRAF V600E | PPA: 99.4% | |
| NPA: 100% |
MELANOMA |
BRAF V600E | PPA: 98.7% |
| NPA: 99.4% | ||
| BRAF V600E/K | PPA: 98.9% | |
| NPA: 99.3% |
NSCLC |
EGFR exon 19 deletions and exon 21 L858R alterations |
PPA: 98.1% |
| NPA: 99.4% |
Solid Tumors |
MSI-H | PPA: 97.5% |
| NPA: 98.5% |
Endometrial |
Not MSI-H | PPA: 98.4% |
| NPA: 97.6% |
†The minimum assay input requirement to perform MI Cancer Seek is ≥50 ng of total nucleic acid. If insufficient quantity is submitted (<50 ng), the order for MI Cancer Seek will automatically reflex to MI Tumor Seek Hybrid™ (LDT).
Intended Use
MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer.
MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table, in accordance with the approved therapeutic product labeling.
Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.
Enhance Molecular Insights with Additional Services
MI Cancer Seek is a single assay that analyzes total nucleic acids for both DNA and RNA. Typically, DNA and RNA analysis by NGS requires two separate testing processes, which may require more tissue and more time. By combining WES and WTS into one assay, however, MI Cancer Seek provides a comprehensive molecular blueprint that saves tissue without compromising results.
Easy-to-Interpret Results
for Clarity in Treatment Planning
Treatment Planning:
- Navigate among FDA-approved drugs and therapies with potential benefit or lack of benefit
- Identify therapies that may not have been considered
- Match patient to clinical trials based on tumor biology
Evidence-guided:
- Drug associations based on peer-reviewed literature and clinical treatment guidelines
- Testing methodologies consistent with industry guidelines
EHR Compatible:
- HITECH compliant
- Easy installation
- Secure encryption
- Real-time sync
Technical Information
For complete product information, including companion diagnostic indications and performance characteristics, view the Technical Information document.
Limitations
FDA Evidence Levels
Contraindications
Warnings and Precautions
Limitations
|
FDA Evidence Levels
| FDA Evidence Levels
Genomic findings other than those listed in the Intended Use are not prescriptive or conclusive for labeled use of any specific therapeutic product. Test results should be interpreted in the context of pathological evaluation of tumors, treatment history, clinical findings, and other laboratory data. Classification Criteria for FDA Evidence Levels
|
Contraindications
There are no known contraindications.
Warnings and Precautions
Biopsy may pose a risk to the patient when archival tissue is not available for use with the assay. The patient’s physician should determine whether the patient is a candidate for biopsy.
Testing Menu
It is more important than ever for cancer patients to have comprehensive molecular testing on their tumors.
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