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Analytical Validation of Blood-Derived Tumor Mutation Burden (bTMB) Assays: A Joint Consensus Recommendation of the BLOODPAC bTMB Analytical Validation Working Group.

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Title: Analytical Validation of Blood-Derived Tumor Mutation Burden (bTMB) Assays: A Joint Consensus Recommendation of the BLOODPAC bTMB Analytical Validation Working Group.
Authors: Baden J; Bristol Myers Squibb, Lawrence Township, New Jersey., Sausen M; Labcorp, Baltimore, Maryland., Anfora AT; LGC Clinical Diagnostics, Milford, Massachusetts., D'Auria KM; Guardant Health, Palo Alto, California., Dickey J; Labcorp, Baltimore, Maryland., Godsey JH; Quest Diagnostics, Secaucus, New Jersey., Guan L; Illumina, San Diego, California., Lococo JS; Illumina, San Diego, California., Mansfield E; Foundation Medicine, Boston, Massachusetts., Meier KL; Illumina, San Diego, California., Merriam D; LGC Clinical Diagnostics, Milford, Massachusetts., Pawloski T; Illumina, San Diego, California., Shukla S; Guardant Health, Palo Alto, California., Stetson D; AstraZeneca, Wilmington, Delaware., Stewart MD; Friends of Cancer Research, Washington, District of Columbia., Wenz P; Illumina, San Diego, California., Leiman LC; BLOODPAC, Chicago, Illinois. Electronic address: lauren@bloodpac.org.
Source: The Journal of molecular diagnostics : JMD [J Mol Diagn] 2025 Oct; Vol. 27 (10), pp. 914-919.
Publication Type: Journal Article; Review; Consensus Statement
Journal Info: Publisher: Elsevier Country of Publication: United States NLM ID: 100893612 Publication Model: Print Cited Medium: Internet ISSN: 1943-7811 (Electronic) Linking ISSN: 15251578 NLM ISO Abbreviation: J Mol Diagn Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Analytical Validation of Blood-Derived Tumor Mutation Burden (bTMB) Assays: A Joint Consensus Recommendation of the BLOODPAC bTMB Analytical Validation Working Group.
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  Data: <searchLink fieldCode="AU" term="%22Baden+J%22">Baden J</searchLink>; Bristol Myers Squibb, Lawrence Township, New Jersey.<br /><searchLink fieldCode="AU" term="%22Sausen+M%22">Sausen M</searchLink>; Labcorp, Baltimore, Maryland.<br /><searchLink fieldCode="AU" term="%22Anfora+AT%22">Anfora AT</searchLink>; LGC Clinical Diagnostics, Milford, Massachusetts.<br /><searchLink fieldCode="AU" term="%22D'Auria+KM%22">D'Auria KM</searchLink>; Guardant Health, Palo Alto, California.<br /><searchLink fieldCode="AU" term="%22Dickey+J%22">Dickey J</searchLink>; Labcorp, Baltimore, Maryland.<br /><searchLink fieldCode="AU" term="%22Godsey+JH%22">Godsey JH</searchLink>; Quest Diagnostics, Secaucus, New Jersey.<br /><searchLink fieldCode="AU" term="%22Guan+L%22">Guan L</searchLink>; Illumina, San Diego, California.<br /><searchLink fieldCode="AU" term="%22Lococo+JS%22">Lococo JS</searchLink>; Illumina, San Diego, California.<br /><searchLink fieldCode="AU" term="%22Mansfield+E%22">Mansfield E</searchLink>; Foundation Medicine, Boston, Massachusetts.<br /><searchLink fieldCode="AU" term="%22Meier+KL%22">Meier KL</searchLink>; Illumina, San Diego, California.<br /><searchLink fieldCode="AU" term="%22Merriam+D%22">Merriam D</searchLink>; LGC Clinical Diagnostics, Milford, Massachusetts.<br /><searchLink fieldCode="AU" term="%22Pawloski+T%22">Pawloski T</searchLink>; Illumina, San Diego, California.<br /><searchLink fieldCode="AU" term="%22Shukla+S%22">Shukla S</searchLink>; Guardant Health, Palo Alto, California.<br /><searchLink fieldCode="AU" term="%22Stetson+D%22">Stetson D</searchLink>; AstraZeneca, Wilmington, Delaware.<br /><searchLink fieldCode="AU" term="%22Stewart+MD%22">Stewart MD</searchLink>; Friends of Cancer Research, Washington, District of Columbia.<br /><searchLink fieldCode="AU" term="%22Wenz+P%22">Wenz P</searchLink>; Illumina, San Diego, California.<br /><searchLink fieldCode="AU" term="%22Leiman+LC%22">Leiman LC</searchLink>; BLOODPAC, Chicago, Illinois. Electronic address: lauren@bloodpac.org.
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  Data: <searchLink fieldCode="JN" term="%22100893612%22">The Journal of molecular diagnostics : JMD</searchLink> [J Mol Diagn] 2025 Oct; Vol. 27 (10), pp. 914-919.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>100893612 <i>Publication Model: </i>Print <i>Cited Medium: </i>Internet <i>ISSN: </i>1943-7811 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2215251578%22">15251578 </searchLink><i>NLM ISO Abbreviation: </i>J Mol Diagn <i>Subsets: </i>MEDLINE
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              Text: 2025 Oct
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