Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial Molecular Analysis for Therapy Choice Clinical Trial
Lih CJ, Harrington RD, Sims DJ, Harper KN, Bouk CH, Datta V, Yau J, Singh RR, Routbort MJ, Luthra R, Patel KP, Mantha GS, Krishnamurthy S, Ronski K, Walther Z, Finberg KE, Canosa S, Robinson H, Raymond A, Le LP, McShane LM, Polley EC, Conley BA, Doroshow JH, Iafrate AJ, Sklar JL, Hamilton SR, Williams PM. Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial Molecular Analysis for Therapy Choice Clinical Trial. Journal Of Molecular Diagnostics 2017, 19: 313-327. PMID: 28188106, PMCID: PMC5397672, DOI: 10.1016/j.jmoldx.2016.10.007.Peer-Reviewed Original ResearchConceptsNext-generation sequencingNational Cancer Institute-Molecular AnalysisMultiple clinical laboratoriesParaffin-embedded clinical specimensTherapy Choice (NCI-MATCH) trialClinical Laboratory Improvement AmendmentsNext-generation sequencing assayPrecision medicine studiesStandard treatmentRefractory cancerClinical trialsBiopsy collectionClinical specimensPanel assayClinical useOverall sensitivityMedicine studiesPairwise concordanceReportable variantsCompliant useNGS assaysTrialsPrecision medicineCell linesClinical laboratories