Caris MI TumorSeek Comprehensive Genomic Profile
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000560898.6
NYS CLEP
CAP
CANCER
Last updated in GTR: 2022-12-27
Last annual review date for the lab: 2024-03-25 LinkOut
At a Glance
Predictive; Therapeutic management
Neoplasm
ABI1 (10p12.1), ABL1 (9q34.12), ABL2 (1q25.2), ACKR3 (2q37.3), ACSL3 (2q36.1), ...
Molecular Genetics - RNA analysis: Whole Transcriptome Sequencing; ...
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Ordering Information
Offered by: Help
How to Order: Help
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 591
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument
RNA analysis
Whole Transcriptome Sequencing
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina NovaSeq 6000
Clinical Information
Test purpose: Help
Predictive; Therapeutic management
Recommended fields not provided:
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The MI TumorSeek Comprehensive Genomic Profile (CGP) panel is validated with an overall accuracy of ≥ 95% when detecting Single Nucleotide Variants (SNV), Insertions and Deletions by looking at over 7500 variants in DNA from 500+ samples, including a comparison to Sanger Sequencing calls for 20 SNV target areas and … View more
Assay limitations: Help
RNA: LOD of 50 ng RNA input and validated 10% as the minimal percent tumor nuclei in a specimen. DNA: LOD of 25 ng DNA input and validated 20% as the minimal percent tumor nuclei in a specimen.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Not provided
NYS CLEP Approval: Help
Number: 62841
Status: Approved
Additional Information

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.