MI Cancer Seek
FDA premarket approval P240010 · decided 2024-11-05
Approval details
- PMA number
- P240010
- Trade name
- MI Cancer Seek
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Caris Life Sciences
- Date received
- 2024-04-01
- Decision date
- 2024-11-05
- Days to decision
- 218 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Phoenix, AZ
- 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
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