Gentronix presents accurate, high-throughput, genotoxicity liability screening to reduce late-stage attrition in drug development
9 Sept 2008Gentronix is committed to helping the pharma industry reduce late-stage attrition by offering accurate and automatable tests for early liability screening. GreenScreen products are cell based assays for use in pharmaceutical genetic toxicity screening using simple, rapid and high-throughput protocols. GreenScreen is designed for use much earlier in drug discovery than the standard test battery for genotoxicity, and provides positive results that are more accurately predictive of in vivo risk than the current in vitro mammalian assays.
A patented GFP reporter system exploits the proper regulation of the GADD45a gene in human p53 competent TK6 host cells. The base assay detects all common mechanistic classes of genotoxin and a new protocol extends this to include the detection of genotoxic metabolites using S9 liver extracts.
Currently 55 companies in 11 countries are using GreenScreen HC data as part of their genotoxicity profiling strategy in drug discovery.
Summary:
- Most accurate genotoxicity screening test available
Unique combination of high specificity and high sensitivity for genotoxic carcinogens - Simple, robust and fast protocol
Microplate based assay with results in 48 hours using standard lab equipment - Conservative use of compound
Enables earlier screening in drug discovery and hence more effective use of resources - Reliable positive data
Avoids unnecessary animal tests and costly late stage failures of lead drug compounds - Compelling economic case
Minimal investment in early genotoxicity screening delivers major savings in time and money.
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GreenScreen HC
Gentronix Ltd.Gentronix has launched a new, accurate and fast in vitro mammalian cell genotoxicity assay - GreenScreen HC. The TK6 host cells are p53 competent and familiar to most genetic toxicology laboratories. A patented GFP reporter system exploits the proper regulation of the GADD45a gene. The assay delivers both high specificity and high sensitivity and detects all common mechanistic classes of genotoxin. The 96-well microplate format takes about 20 minutes to prepare and delivers results after a 48 hour incubation. A single microplate is sufficient for the simultaneous testing of 4 compounds over 9 serial dilutions. The protocol is also readily automated using standard laboratory liquid-handling equipment. The Biology GADD45a mediates the adaptive response to genotoxic stress. The patented GFP fluorescence reporter includes complex regulatory elements. The assay gives positive results for direct acting agents, as well as aneugens, and topoisomerase and polymerase inhibitors. Importantly the assay gives correct negative results for non-carcinogens, including many which give misleading positive results in other in vitro tests. The Assay Protocol Nine, 2-fold dilutions of each compound together with positive controls are set out in the microplate and growing cells are added to each well. After incubation and measurement in a microplate reader, simple software gives automated decisions and a clear graphical output. Validation A unique combination of both high-specificity and high-sensitivity genotoxicity assessment in a human cell line has been demonstrated. See: High-specificity and high-sensitivity genotoxicity assessment in a human cell line: Validation of the GreenScreen HC GADD45a-GFP genotoxicity assay. Hastwell P.W. et al (2006) Mutation Research 607: 160-175.