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

HercepTest to Herceptin clinical outcome has not been established. NOTE for gastric cancer only: All of the patients in the phase III BO18255 (ToGA) study sponsored by Hoffmann-La Roche were selected using DakoHercepTest (IHC) and Dako HER2 FISH pharmDx? Kit (FISH). However, enrollment in the BO18255 study was limited to patients whose tumors were HER2 protein overexpressing (IHC 3+) or gene amplified (FISH+; HER2/CEN-17 ratio ≥ 2.0). No patients were enrolled whose tumors were not gene amplified but HER2 protein weakly to strongly overexpressing [FISH(-)/IHC 2+], therefore it is unclear if patients whose tumors are not gene amplified but HER2 protein overexpressing [i.e., FISH(-), IHC 2+ or 3+] will benefit from Herceptin treatment. The study also demonstrated that gene amplification and protein overexpression (IHC) are not as correlated as with breast cancer, therefore a single method should not be used to determine HER2 status. Herceptin BLA 103792; HER2 FISH PharmDx Kit P040005S001-S010Dako Denmark A/S HER2 IQFISH pharmDx is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HER2 IQFISH pharmDx is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin (trastuzumab) treatment is being considered and for breast cancer patients for whom Perjeta (pertuzumab) or Kadcyla (ado-trastuzumabemtansine) treatment is being considered (see Herceptin, Perjeta and Kadcyla package inserts). (trastuzumab); Perjeta (pertuzumab); BLA 125409 Kadcyla (ado-trastuzumabemtansine) For breast cancer patients, results from the HER2 IQFISH pharmDx are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients. therascreen? EGFR RGQ PCR P120022S001Kit Iressa (gefitinib) NDA 206995Qiagen 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 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) or IRESSA? (gefitinib), EGFR tyrosine kinase inhibitors (TKIs), is indicated. Safety and efficacy of GILOTRIF (afatinib) and IRESSA (gefitinib) have not been established in the 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. KEYTRUDA? (pembrolizumab) BLA 125514/s-5PD-L1 IHC 22C3 pharmDx P150013Dako, North PD-L1 IHC 22C3 pharmDx is a qualitative America, Inc. immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining. The specimen should be considered