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1、List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)Drug Trade NameNDA/BLADevice Trade NamePMADevice ManufacturerIntended Use (IU)/ Indications for Use (IFU)(Generic Name)Erbitux (cetuximab);BLA 125084;DAKO EGFR PharmDx KitP030044S001-S002Dako North America, Inc.The
2、EGFR pharmDx assay is a qualitative immunohistochemical (IHC) kit system to identify epidermal growth factor receptor (EGFR) expression in normal and neoplastic tissues routinely-fixed for histological evaluation EGFR pharmDx specifically detects the EGFR (HER1) protein in EGFR-expressing cells.Vect
3、ibixBLA 125147(panitumumab)EGFR pharmDx is indicated as an aid in identifying colorectal cancer patients eligible for treatment with Erbitux (cetuximab) or Vectibix (panitumumab).Erbitux (cetuximab); Vectibix (panitumumab)BLA 125084;BLA 125147therascreenKRAS RGQ PCR KitP110030Qiagen Manchester, Ltd.
4、The therascreen KRAS RGQ PCR Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene, using DNA extracted from formalin-fixed paraffin-embedded (FFPE), colorectal cancer (CRC) tissue. The therascreen KRA
5、S RGQ PCR Kit is intended to aid in the identification of CRC patients for treatment with Erbitux (cetuximab) and Vectibix (panitumumab) based on a KRAS no mutation detected test result.P110027Erbitux (cetuximab); Vectibix (panitumumab)BLA 125084;BLA 125147The cobas KRAS Mutation TestP140023Roche Mo
6、lecular Systems, Inc.The cobas KRAS Mutation Test, for use with the cobas 4800 System, is a real-time PCR test for the detection of seven somatic mutations in codons 12 and 13 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test i
7、s intended to be used as an aid in the identification of CRC patients for whom treatment with Erbitux (cetuximab) or with Vectibix (panitumumab) may be indicated based on a no mutation detected result. Specimens are processed using the cobas DNA Sample Preparation Kit for manual sample preparation a
8、nd the cobas z 480 analyzer for automated amplification and detection.ExjadeNDA 021882FerriscanK124065Resonance Health Analysis Services Pty LtdThe FerriScan R2-MRI Analysis System is intended to measure liver iron concentration to aid in the identification and monitoring of non-transfusion dependen
9、t thalassemia patients receiving therapy with deferasirox.(deferasirox)GilotrifNDA 201292therascreen EGFR RGQ PCR KitP120022Qiagen Manchester, Ltd.The therascreen EGFR RGQ PCR Kit is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of
10、 the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients with NSCLC for whom GILOTRIF (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indic
11、ated. Safety and efficacy of GILOTRIF (afatinib) have not been established in patients whose tumors have L861Q, G719X, S768I, exon 20 insertions, and T790M mutations, which are also detected by the therascreen EGFR RGQ PCR Kit.(afatinib)Specimens are processed using the QIAamp DSP DNA FFPE Tissue Ki
12、t for manual sample preparation and the Rotor-Gene Q MDx instrument for automated amplification and detection.Gleevec/GlivecNDA 021335;DAKO C-KIT PharmDxP040011S001-S002Dako North America, Inc.The c-Kit pharmDX assay is a qualitative immunohistochemical (IHC) kit system used on the Dako Autostainer,
13、 for the identification of c-kit protein/CD 117 antigen (c-kit protein) expression in normal and neoplastic formalin-fixed paraffin-embedded tissues for histological evaluation. The c-Kit pharmDX rabbit polyclonal antibodies specifically detect the c-kit protein in CD 117 antigen-expressing cells.(i
14、matinib mesylate)NDA 021588The c-Kit pharmDx is indicated as an aid in the differential diagnosis of gastrointestinal stromal tumors (GIST). After diagnosis of GIST, results from c-Kit pharmDx may be used as an aid in identifying those patients eligible for treatment with Gleevec/Glivec (imatinib me
15、sylate).Results from hematoxylin and eosin (H&E) stains and a panel of antibodies can aid in the differential diagnosis of GIST. Interpretation must be made by a qualified pathologist, within the context of a patients clinical history, proper controls, and other diagnostic tests.HerceptinBLA 103792I
16、NFORM HER-2/NEUP940004S001Ventana Medical Systems, Inc.The Inform Her-2/Neu gene detection system is a fluorescence in situ hybridization (FISH) DNA probe assay that determines the qualitative presence of Her-2/Neu gene amplification on formalin-fixed, paraffin embedded human breast tissue as an aid to stratify breast cancer patients according
