Biomaterials and Biomedical Devices

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Biomaterials and Biomedical Devices

Early In vitro screening for genotoxicity

  • Saves money and improves productivity
  • Enables chemists to modify materials to reduce genotoxicity without losing desirable properties
  • Gives a clear early assessment of genotoxic hazard

Further assays to understand the causes of positive results

  • Clearer decision to keep or reject candidate materials
  • Additional information to prioritise further testing

Why screen early?

Biological evaluation of medical devices is performed to determine the potential toxicity resulting from contact of the component materials of the device with the body. As one of the requirements the device materials should not, either directly or through the release of their material constituents: be carcinogenic or produce adverse reproductive and developmental effects.

Therefore, evaluation of any new device intended for human use requires data from systematic testing to ensure that the benefits provided by the final product will exceed any potential risks. It is therefore important to have a clear understanding of the potential genotoxicity of the materials to ensure compliance with the various regulatory bodies.

The very high levels of both sensitivity and specificity achieved with GreenScreen HC and BlueScreen HC, provides a valuable insight into genotoxicity liability; often at a very early screening stage in compound development.  This represents a direct and very important benefit when considering the essential requirement to provide laboratory and manufacturing staff personal protection in terms of Health and Safety.

When to Screen

The earlier a material is screened the greater the cost and time saving because the cost of rejecting a material based on genotox screening late in the development process is more than 10x greater than if it had been rejected at the discovery stage. Early hazard assessment provides a cost effective and expedient approach to increase productivity.