Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - pathology - pd-l1 ihc 28-8 pharmdx is a qualitative immunohistochemical assay using monoclonal rabbit anti-pd-l1, clone 28-8 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-squamous non-small cell lung cancer (nsnsclc) and muscle invasive urothelial carcinoma (miuc) tissues using envision flex visualization system on autostainer link 48. pd-l1 protein expression in nsnsclc and miuc is determined by using % tumor cell expression, which is the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. pd-l1 ihc 28-8 pharmdx is indicated as an aid in identifying miuc patients with ≥ 1% tumor cell pd-l1 expression for treatment with opdivo® (nivolumab). pd-l1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in non-squamous nsclc (nsnsclc) may be associated with enhanced survival from opdivo® (nivolumab).

Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - immunology - for in vitro diagnostic use. flex monoclonal mouse anti-cytomegalovirus, clone cch2 + ddg9 ready-to-use, is intended for use in immunohistochemistry together with autostainer instruments. this antibody is useful for the identification of human cytomegalovirus (hcmv)-infected tissues. the clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - immunology - flex ready-to-use (autostainer/autostainer plus/link) immunohistochemistry reagents are intended for use together with autostainer/autostainer plus/autostainer link instruments, to identify antigens in tissues or cytologic specimens and are used after the primary diagnosis, and for use in diagnosis/staging/characterization of blood cancers, or detection of other hematology markers.

Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - gastroenterology & urology - 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 adenocarcinoma of the stomach including gastro-esophageal junction. her2 iqfish pharmdx is indicated in adjunction to herceptest™ in the assessment of patients for whom herceptin™ (trastuzumab) treatment is being considered. for breast cancer patients, results from 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.

Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - gastroenterology & urology - her2 iqfish pharmdx (dako omnis) is the hybridization probe for the automated direct fluorescence in situ hybridization (fish) assay onboard dako omnis instruments and is, together with accessory reagent devices, designed to quantitatively determine her2 gene amplification in formalin-fixed, paraffin-embedded (ffpe) breast cancer tissue specimens and ffpe specimens from patients with adenocarcinoma of the stomach including gastro-esophageal junction. her2 iqfish pharmdx is indicated in adjunction to herceptest™ in the assessment of patients for whom herceptin™ (trastuzumab) treatment is being considered. for breast cancer patients, results from her2 iqfish pharmdx (dako omnis) are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage ii, node-positive breast cancer patients.

Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - immunology - intended to be used to identify, by immunological techniques, antigens in tissues or cytologic specimens, and are used after the primary diagnosis.

Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - immunology - intended to be used to identify, by quantitative immunological techniques, antigens in tissues or cytologic specimens, and are used after the primary diagnosis.

Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - immunology - for in vitro diagnostic use. monoclonal mouse anti-human pd-l1, clone 22c3, is intended for use in immunohistochemistry. this antibody labels pd-l1 in normal and neoplastic tissue. the clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a certified pathologist. this antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.

Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - pathology - pd-l1 ihc 22c3 pharmdx is a qualitative 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), gastric or gastroesophageal junction (gej) adenocarcinoma, esophageal squamous cell carcinoma (escc), cervical cancer, urothelial carcinoma, head and neck squamous cell carcinoma (hnscc), and triple-negative breast cancer (tnbc) tissues using envision flex visualization system on autostainer link 48.

Singapore - engelsk - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - pathology - for in vitro diagnostic use. pd-l1 ihc 22c3 pharmdx is a qualitative 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 dako omnis. pd-l1 protein expression in nsclc is determined by using tumor proportion score (tps), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. the specimen should be considered to have pd-l1 expression if tps ≥ 1% and high pd-l1 expression if tps ≥ 50%. pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying nsclc patients for treatment with keytruda® (pembrolizumab). see keytruda® product label for expression cutoff values guiding therapy in specific clinical circumstances.