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FDA-approved companion diagnostic

MI Cancer Seek (MCS)

Tissue-based whole-exome and whole-transcriptome NGS assay using total nucleic acid from FFPE tumors to detect key biomarkers and support targeted therapy selection.

Lab-developed CDxMethod: NGSSpecimen: Tissue (FFPE)Biomarker: Multiple genomic alterations
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P240010
Supplements
Manufacturer
Caris Life Sciences
Approval date
November 5, 2024
Test specifications
Methodology
NGS
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
What this test is

MI Cancer Seek (MCS) is an FDA-approved next-generation sequencing assay that performs simultaneous whole exome and whole transcriptome analysis on total nucleic acid from FFPE solid tumors. It detects multiple clinically relevant genomic alterations and expression changes, providing a comprehensive profile to support biomarker-driven treatment decisions in adult and pediatric patients ages 1–22.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerPIK3CAC420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047YPIQRAY
Colorectal Cancer (CRC)BRAFV600EBRAFTOVI + ERBITUX
KRAS and NRASwild-type (absence of mutations in exons 2, 3 and 4)VECTIBIX
Endometrial Carcinoma (EC)Not MSI-HighNot Microsatellite Instability-High (Not MSI-H)KEYTRUDA + LENVIMA
MelanomaBRAFV600ETAFINLAR, ZELBORAF
V600E and V600KBRAFTOVI + MEKTOVI, COTELLIC + ZELBORAF, TAFINLAR + MEKINIST
V600E or V600KMEKINIST
Non-Small Cell Lung Cancer (NSCLC)EGFR (HER1)Exon 19 deletion or exon 21 L858R substitution mutationGILOTRIF, IRESSA, LAZCLUZE + RYBREVANT, TAGRISSO, TARCEVA, VIZIMPRO
Solid TumorsMSI-HighMicrosatellite instability-HighJEMPERLI, KEYTRUDA

Performing lab

Caris Life Sciences

Tissue Lab (03D1019490)

Caris Life Sciences® (Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer that is actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms at scale, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of next-generation sequencing, AI and machine learning technologies, and high-performance computing provides a differentiated platform to develop the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development. 

Caris was founded with a vision to realize the potential of precision medicine in order to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets.

Order this test

If your organization is connected to Casandra, you can place an electronic order for MI Cancer Seek (MCS) directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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