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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMI Cancer Seek
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantCaris Life Sciences
4610 South 44th Place
Phoenix, AZ 85040
PMA NumberP240010
Date Received04/01/2024
Decision Date11/05/2024
Product Code PQP 
Docket Number 24M-5719
Notice Date 12/20/2024
Advisory Committee Molecular Genetics
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval order for MI Cancer Seek. 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 Table 1 below, in accordance with the approved therapeutic product labeling (see approval order for Table 1).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 Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 
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