发布时间 : 星期四 文章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更新完毕开始阅读4aee3d25dcccda38376baf1ffc4ffe473268fd43
List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)
Drug Trade Name (Generic Name) Erbitux (cetuximab); BLA 125084;DAKO EGFR PharmDx Kit P030044S001-S002NDA/BLA Device Trade Name PMA Device Intended Use (IU)/ Indications for Use (IFU) Manufacturer Dako North The EGFR pharmDx? assay is a qualitative America, Inc. 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. EGFR pharmDx is indicated as an aid in identifying colorectal cancer patients eligible for treatment with Erbitux (cetuximab) or Vectibix (panitumumab). Vectibix (panitumumab) BLA 125147 Erbitux (cetuximab); Vectibix BLA therascreenKRAS RGQ PCR P110030(panitumumab) 125084;BLA Kit 125147 Qiagen Manchester, Ltd. P110027The 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 KRAS 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. Erbitux (cetuximab); Vectibix BLA The cobas? KRAS Mutation P140023(panitumumab) 125084;BLA Test 125147 Roche Molecular 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 is 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 and the cobas z 480 analyzer for automated amplification and detection. The FerriScan R2-MRI Analysis System is intended to measure liver iron concentration to aid in the identification and monitoring of non-transfusion dependent thalassemia Exjade NDA 021882Ferriscan K124065Resonance Health Analysis Services Pty (deferasirox) Gilotrif NDA 201292 therascreen EGFR RGQ PCR P120022Kit Ltd Qiagen Manchester, Ltd. patients receiving therapy with deferasirox. 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 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 indicated. 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. Specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene Q MDx instrument for automated amplification and detection. (afatinib) Gleevec/Glivec NDA 021335; DAKO C-KIT PharmDx P040011S001-S002Dako North The c-Kit pharmDX assay is a qualitative America, Inc. immunohistochemical (IHC) kit system used on the DakoAutostainer, 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. The 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 (imatinibmesylate). 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 patient's clinical history, proper controls, and other diagnostic tests. (imatinibmesylate) NDA 021588