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Dako, an Agilent Technologies Company, Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma

Agilent Technologies

Dako, an Agilent Technologies Company, Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma

11 Feb 2016
Alex Waite
Editorial Assistant

Product news

Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, has announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the intended use of Dako PD-L1 IHC 28-8 pharmDx to include patients with melanoma.

Dako's PD-L1 IHC 28-8 pharmDx diagnostic first received approval from the FDA on Oct. 9, 2015, for non-squamous, non-small cell lung cancer (NSCLC). The complementary test has now been expanded to include melanoma and may be used by physicians to determine PD-L1 status. Positive PD-L1 status in melanoma has been correlated with the magnitude of treatment effect on progression-free survival from OPDIVO® (nivolumab), from Bristol-Myers Squibb. These complementary tests are distinct from companion diagnostics, which are essential for safe and effective use of a drug. Biomarker testing is not required for the OPDIVO + YERVOY® Regimen or OPDIVO as a single-agent, but it may provide additional information for physicians regarding the use of OPDIVO.

"We are truly excited about the FDA's approval of the PD-L1 test for use in melanoma in addition to the lung indication we received last year," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "This is testimony to the extensive work that has gone into developing this highly useful test and underlines the importance of the PD-L1 marker. Agilent proves its leadership yet again in the diagnostics space, as we are the first company providing FDA-approved tests for lung cancer and melanoma for PD-L1 markers."

Dako is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.

Information about Agilent is available at www.agilent.com, and information about Dako products is available here.

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BiosensorsBiosensors are devices used to detect an analyte using biological molecules specific to the analyte coupled to a detector. Biosensor instruments may be photometric, typically using surface plasma resonance (SPR), electrochemical or QCM (quartz crystal microbalance) biosensors. Biosensors should be selective, portable, robust and sensitive and have a fast response time. Systems may be manual or automated and usually have associated software.Combinatorial ChemistryCombinatorial chemistry, also known as combichem, is a technique used in drug discovery to create libraries of structurally related compounds. A library is generated by synthesis with a chemical reactor system or by computer-based modeling of compound combinations. When undertaking combinatorial chemistry consider reagents, buffers, resins and standards.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Cellular PathologyCellular Pathology deals with the microscopic analysis of tissue samples and cells. Sample preparation and processing includes fixation, staining, sectioning and slide mounting, using equipment such microtomes and cryostats. In choosing immunohistochemistry and immunocytochemistry kits, consider chromogens, staining method, antibodies, microscopes and imaging.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Cancer DiagnosticsThere are a wide variety of diagnostic tests for cancer available, and this range continues to expand as our knowledge of cancer improves. Current diagnostic methods include biopsy, imaging and blood tests for known biomarkers. New methods in research development include liquid biopsies and cancer breathalyzers.MelanomaLung CancerLung cancer is a leading cause of cancer-related deaths worldwide, often diagnosed at an advanced stage. Research focuses on early detection, targeted therapies, and personalized treatment strategies. Explore lung cancer research and diagnostic products in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Molecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. ImmunohistochemistryImmunohistochemistry (IHC) is a technique used to detect specific proteins in tissue samples by using antibodies that bind to target antigens. IHC is widely applied in pathology, immunology, hematology and cancer diagnostics. Explore IHC tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Biomarker DiscoveryClinical biomarkers refer to substances related to known medical conditions that can be accurately measured <i>in vitro</i>. Biomarkers can be used to diagnose presence of a disease and indicate disease severity. The discovery of new biomarkers is incredibly valuable in the field of diagnostics.

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