Spotlight Drug Discovery & Pharmaceutical Analysis Genotoxicity Assay Scores Top Marks in New Pharmaceutical Study


Gentronix showcased its latest product and service developments at the Society of Toxicology 49th Annual Meeting and ToxExpo Salt Lake City. New research using 75 marketed pharmaceuticals shows GreenScreen HC from Gentronix is more predictive for genotoxic carcinogenicity than existing regulatory in vitro assays. Published in Mutagenesis, the analysis provides additional evidence to support the use of the Gentronix assay in the early identification of genotoxic liability or in non-clinical safety assessment of candidate pharmaceuticals during development. As well as more accurate prediction of in vivo genotoxicity (88%) and genotoxic carcinogenicity (93%) than other in vitro genotoxicity tests, the assay maintained its high specificity: no new genotoxicity and/or carcinogenicity alerts were produced for any of the compounds tested.


All marketed pharmaceuticals have other published regulatory in vitro and in vivo genotoxicity data, and often carcinogenicity study data. These allow accurate calculation of predictive statistical data. The accumulated data from carcinogenicity and regulatory genotoxicity studies to date, including this new study, shows the overall specificity and sensitivity of GreenScreen HC for genotoxic carcinogenicity to be 95% and 87.5% respectively. Data from this human cell-based assay has application in ‘weight of evidence’ approaches when assessing the biological relevance of positive in vitro mammalian cell assay data, where no bacterial mutagenicity has been observed, prior to conducting in vivo testing. With the high throughput, low resource and compound requirement of GreenScreen HC, data can be generated at an earlier stage of the drug development process. This additionally allows prioritisation of compounds to be progressed for non-clinical studies to support clinical investigations.


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Platform for a Complete Drug Discovery Solution


Label-Free Screening Platform


PharmaDiagnostics NV announced the launch of SoPRano(TM), a high-performance set of screening tools to accelerate the drug discovery process for pharmaceutical and biotechnology companies. SoPRano(TM)'s key advance is to use the proven principle of surface plasmon resonance (SPR) and make it available in high throughput on a standard plate-reader, without the need for costly specialist equipment. PharmaDiagnostics already offers ADME/PK and custom assay development products and services, and is working with leading research groups to introduce regular further platform enhancements in new application areas.


Label-free screening is currently an area of great interest in the pharmaceutical research market. PharmaDiagnostics' approach stands out as all other available label-free technologies require expensive dedicated equipment that restricts both breadth of application and compound throughput. PharmaDiagnostics' localised surface plasmon resonance technology (LSPR) is broadly enabling, with easy to use protocols, and is applicable to a range of assays for both small molecule and antibody screening and characterisation. For the first time, label-free screening can be applied in high throughput applications. "With SoPRano(TM), PharmaDiagnostics is providing label-free screening for a much broader range of researchers," said Dr David Ricketts, CEO at PharmaDiagnostics. "Early customer feedback has been extremely positive. This product launch at Screening Europe and our new corporate website and online SoPRano(TM) facility demonstrates PharmaDiagnostics' commitment to develop and enhance SoPRano(TM) and bring our customers real value."


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Cisbio Bioassays announced that it has introduced six multi- mode cell lines to its expanding Tag-lite®


cellular platform.


These new, multi-mode cell lines enable researchers to investigate the biological complexity of cell membrane receptors using the same cellular material, making Tag-lite a complete drug discovery solution for GPCR studies. In related Tag-lite news, five new fluorescent ligands, including ones for GABA-B and Grehlin receptor binding assays, have been added to enhance the platform, bringing the current number of ligands to 18.


Tag-lite is a non-radioactive, cell-based technological platform for cell surface receptor study and screening. Membrane receptors, in particular GPCRs, are major therapeutic targets in pharmaceutical research as they are involved in every aspect of human physiology. Given their biological complexity, Cisbio Bioassays developed the Tag-lite platform to provide a multi- angle investigational tool that addresses their structure and function, from ligand binding and dimerisation to second messengers and ERK phosphorylation. Tag-lite multi-mode cell lines now enable this analysis using the same cellular material, eliminating the need for researchers to develop and qualify their own cells for multiple assays.


Tag-lite cell lines released include, in particular, important GPCR targets such as CXCR4, as well as other chemokine receptors and cholecystokinin receptors. The cell lines have all been validated with HTRF reagents and kits for receptor ligand binding assays, receptor homodimerisation assays, functional assays (Cellul’erk) and second messenger accumulation assays (cAMP and IP-One). The Tag-lite platform’s growing catalogue of ligands, plasmids, cell lines, binding kits and assays enable scientists to investigate and screen using one solution. In addition, Cisbio Bioassays offers custom labeling and full assay development services for dimerisation and binding, led by its multi-disciplinary team of chemists, molecular and cellular biologists, and fluorescence technology and receptor specialists.


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Improved Non-Invasive Testing


Oxoid has improved its RAPID Hp StAR™ test for the detection of Helicobacter pylori antigen in stool samples. The test now delivers improved sensitivity and specificity, thus enhancing overall performance. RAPID Hp StAR is a rapid immunochromatographic membrane based assay that provides reliable results in just 15 minutes, without the need for special equipment. The speed and simplicity of this method make it suitable for small volume testing within the laboratory, or for near patient testing in gastroenterology clinics and doctors’ surgeries. Such convenience is ideal for monitoring the efficacy of antimicrobial treatment without the need for return hospital visits.


Also available is the Oxoid IDEIA™ Hp StAR test, which is a highly sensitive and specific enzyme immunoassay. The test is easy to perform using standard equipment, allowing the ‘test and treat’ policy recommended by the European Helicobacter Study Group to be implemented in routine laboratories. It is suitable for both manual and automated testing and has demonstrated excellent performance when compared to the urea breath test and alternative enzyme immunoassays.


Using a combination of unique amplification technology and monoclonal antibodies, both non-invasive tests are performed using a patient stool sample. They detect H. pylori antigen with a high degree of accuracy and can be used to diagnose current infection in both adult and paediatric patients. Unlike serology methods, these stool antigen tests can be used to detect active infection and to confirm the eradication of H. pylori following antibiotic therapy.


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Putting More Drug Discovery Tools in Customers Belt


LGC Standards has launched a new absorption, distribution, metabolism and excretion (ADME) toxicology guide comprising a unique collection of labelled and unlabelled reagents and standards, as well as important biological model systems. The Tools for ADME/Tox guide provides reference to Food and Drug Administration (FDA) guidelines and has specifically been developed for preclinical drug discovery and development scientists working across the spectrum of ADME and toxicology preclinical drug discovery and research.


The guide’s quick reference tables provide details of key metabolising enzymes with relevant substrates, metabolites, inhibitors and inducers. These tables then link to an alphabetical product listing which enable researchers to easily locate the specific reference standards and reagents required for their assays. The listing includes FDA Drug Development and Drug interaction guidance listing substrates, inhibitors and inducers as either preferred or acceptable. A significant number of metabolite standards are also available both labelled and unlabelled, with each product format’s availability clearly indicated. The guide comprises a collection of model systems commonly used in preclinical drug discovery research. The range includes fresh hepatocytes from a series of species, available the day after isolation and key immortalised cell lines such as Caco-2 (HTB-37™) and primary cells from ATCC®


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