FDA批准的精准医疗诊断体外器械一览表List of Cleared or Approved Companion Diagnostic Devices

PD-L1 positive if TPS ≥ 50% of the viable tumor cells exhibit membrane staining at any intensity. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA? (pembrolizumab). Lynparza? (olaparib) NDA 206162BRACAnalysisCDx? P140020Myriad Genetic Laboratories, Inc. BRACAnalysisCDx? is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparza? (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108. Mekinist (tramatenib); NDA Tafinlar (dabrafenib) 204114; THxID? BRAF Kit P120014bioMérieux Inc. NDA 202806 The THxID BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanoma tissue. The THxID? BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist]. The cobas? EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded tumor tissue (FFPET) from non-small cell lung cancer Tagrisso? (osimertinib) NDA 208065cobas? EGFR Mutation Test P120019S007v2 Roche Molecular Systems, Inc. (NSCLC) patients. The test is intended to aid in identifying patients with NSCLC whose tumors have defined EGFR mutations and for whom safety and efficacy of a drug have been established as follows: Tarceva? (erlotinib) - Exon 19 deletions and L858R Tagrisso? (osimertinib) - T790M Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas? EGFR Mutation Test v2: Tarceva? (erlotinib) - G719X, exon 20 insertions, T790M, S768I and L861Q Tagrisso? (osimertinib) - G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q For manual sample preparation, FFPET specimens are processed using the cobas? DNA Sample Preparation Kit and the cobas z480 analyzer is used for automated amplification and detection. Tarceva (erlotinib) NDA 021743 cobas EGFR Mutation Test P120019S001-S004Roche Molecular Systems, Inc. The cobas? EGFR Mutation Test is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) human non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used as an aid in selecting patients with NSCLC for whom Tarceva? (erlotinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated. The cobas? EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood. Tarceva? (erlotinib) 21743cobas? EGFR Mutation Test P150047v2 Roche Molecular Systems, Inc.