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BioReliance Launches Next-Generation Genotoxicity Screening Service
BioReliance has contracted with Gentronix to offer their GreenScreen HC in vitro assay as a major part of BioReliance's portfolio of genotoxicity screening services. GreenScreen HC, in conjunction with Ames II assays, allows pharmaceutical companies to test for genotoxic potential earlier in the preclinical development process, using only a few milligrams of test compound as opposed to the gram quantities required by current ICH regulatory tests. Click here to read the press release.
Bioreliance Launches iNet, a Web-Based Tool for tracking Electronic Submissions of Biologics Tests
BioReliance is pleased to announce the release of iNet, a proprietary information technology system for submitting and tracking test article details via a controlled and secure Internet access from any location worldwide. Now you can view the status of current and past studies, keep informed of when testing will be completed, download reports, and allow your colleagues to view the status of your tests. iNet is currently available to US biologics testing customers upon request, but will be made available to a larger audience soon. Click here to read the press release.
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Determining the safety of a product, whether it is a pharmaceutical, biopharmaceutical, medical device or pesticide, may also include demonstrating its genotoxic potential.
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Back to Genetic Toxicology
Primary DNA damage represents possible premutational events that can be detected, either directly or indirectly, by a number of techniques using mammalian cells in culture or using rodent tissue. The unscheduled DNA synthesis (UDS) assay measures the ability of a test article to induce DNA lesions by measuring the increase in DNA repair. Autoradiography permits the visualization of DNA repair in cultured rodent hepatocytes. Sister chromatid exchanges (SCEs) represent the exchange, requiring breakage and reunion, of DNA replication products at apparently homologous loci of sister chromatids. Differential staining techniques allow visualization and rapid identification of the exchanges in cultured mammalian cells, as well as in rodent bone marrow or spermatogonial cells. The COMET assay, also known as single cell gel electrophoresis (SCG), is a microgel DNA electrophoresis technique that detects DNA damage and repair in individual cells. The COMET assay is conducted in both in vitro and in vivo systems and is increasingly being used in genotoxic testing.
Assays offered by BioReliance:
- In Vitro Unscheduled DNA Synthesis
- Unscheduled DNA Synthesis Assays for Medical Devices
- In Vivo/In Vitro Unscheduled DNA Synthesis
- COMET Assay/DNA Damage Assay
- DNA Damage to Germ Cells
- In Vitro Sister Chromatid Exchange
- In Vivo Sister Chromatid Exchange
| UDS assay in primary rat hepatocytes |
380 |
| UDS assay in primary rat hepatocytes with an independent repeat |
380001 |
| Biocompatibility testing of Medical Devices: Screening test |
380201 |
| Biocompatibility testing of Medical Devices: Full test |
380200 |
| Rat liver UDS assay |
381 |
| Mouse liver UDS assay |
382 |
| Rat Dose Range Finding Test |
000R |
| In vitro CHO Comet Screening Assay |
400 |
| In vitro Retinal Comet Screening Assay |
401 |
| In vivo Rodent COMET Assay |
410 |
| Detection of Single-Strand Breaks |
390 |
| Detection of Cross-Links |
391 |
| Sister Chromatid Exchange Assay (SCE) in CHO Cells |
350 |
| Sister Chromatid Exchange (SCE) Assay in Human Peripheral Lymphocytes |
351 |
Transformation assays available at BioReliance allow in vitro evaluation of carcinogenic potential using Syrian hamster embryo (SHE) cells or BALB/3T3 cells. The most frequently used endpoint for cell transformation is morphological transformation of mammalian cell fibroblasts in culture. Subsequent passage of these aberrant foci allows the expression of other characteristic phenotypes of malignant transformation, which include growth in soft agar and tumor formation in syngeneic hosts.
Assays offered by BioReliance:
- Syrian Hamster Embryo (SHE) cell Transformation Assay
- BALB/3T3 Transformation Assay
| Syrian Hamster Embryo (SHE) cell transfomation assay with 7-day treatment regimen |
308 |
| Syrian Hamster Embryo (SHE) cell transformation assay with 24-hour treatment regimen |
309 |
| Syrian Hamster Embryo (SHE) cell transformation assay with 24-hour and 7-day treatment regimens |
310 |
| In Vitro Transformation Assay in BALB/3T3 Cells with and without S9 activation |
304 |
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