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Paneles comerciales disponibles para la
determinación de TMB
Company/Institution
CLIA or RUO
Test Name
# Genes
Status
Foundation Medicine, Inc
1,2
CLIA
FoundationOne CDx™
324
FDA-approved
Memorial Sloan Kettering
3
CLIA
MSK-IMPACT
468
Market authorization from FDA
Illumina
4
RUO
TruSight
®
Tumor 170
170
Research use only
Thermo Fisher
5
RUO
Ion AmpliSeq
TM
Comprehensive Gene Panel
409
Research use only
Qiagen
6
RUO
QiaSeq DNA Comprehensive Cancer Panel
275
Research use only
Roche
7
RUO
SeqCap EZ Comprehensive Cancer
578
Research use only
Caris Life Sciences
8
RUO
MI Tumor Seek
TM
592
Research use only
CLIA=Clinical Laboratory Improvement Amendments; RUO=research use only.
1. FDA [press release]. November 30, 2017. 2. Foundation Medicine.
https://www.foundationmedicine.com/genomic-testing/foundation-one.Accessed November 30, 2017. 3. FDA [press release]. November 15, 2017.
4. Illumina.
https://www.illumina.com/content/dam/illumina-marketing/documents/products/whitepapers/trusight-tumor-170-tmb-analysis-white-paper-1170-2017-001.pdf.Accessed November 30, 2017. 5. Thermo
Fisher.
https://www.thermofisher.com/order/catalog/product/4477685.Accessed November 30, 2017. 6. Qiagen.
http://www.transmedchina.com/upload/file/20170703/20170703160737033703.pdf. Accessed December 4, 2017. 7. Roche.
http://sequencing.roche.com/en/products-solutions/by-category/target-enrichment/shareddesigns.html.Accessed December 4, 2017. 8. Caris Life
Sciences.
https://www.carislifesciences.com/news/caris-life-sciences-applauds-cms-decision-reaffirm-longstanding-coverage-next-generation-sequencing-assay/.Accessed April 10, 2018.