Ban on Animal Testing

The development and validation of non-animal tests for toxicology testing opens a large market for Xgene Corporation. In Europe, several organizations have been created to evaluate (and validate) alternatives to existing animal tests. The following is included as background information on the efforts of these organizations and the directives from European Economic Community that govern their actions.

DIRECTIVE 86/609/EEC

Article 23

The commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals, but which involve fewer animals or which entail less painful procedures, and shall take such other steps as they consider appropriate to encourage research in this field. The commission and Member States shall monitor trends in experimental methods.

Article 7.2

An experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of animals, is reasonably and practicably available.

These policies have lead to the creation of several organizations that are supporting and standardizing methods to be used in in vitro testing. The European Centre for Validation of Alternative Methods (ECVAM) has been created, and for marketing in Europe Xgene Corporation will seek validation for the in vitro CESSE. ECVAM's mission statement is shown below:

To coordinate the independent evaluation of the relevance and reliability of tests for specific purposes, and in particular through prevalidation and validation studies, so that chemicals and products of various kinds, including medicines, vaccines, other biologicals, medical devices, cosmetics, household products and agricultural products, can be manufactured, transported and used more economically and more safely, whilst the current reliance on animal test procedures is progressively reduced.

In ECVAM's first meeting in 1993 they stated that "ECVAM will promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals." For sales in Europe it will be necessary for Xgene to have its CeSSE assays validated by ECVAM. Xgene Corporation's work will be to develop the in vitro CeSSE model, and actively seek validation from organizations such as ECVAM. There are other country organizations involved in these efforts, including ZEBET (Centre for Documentation and Evaluations of Alternatives to Animal Testing) in Germany and COLIPA (The European Cosmetic Toiletry and Perfumery Association). A complete ban on animal testing for all testing applications was enacted for January 1, 2009.

An analogous organization, Interagency Coordinating Committee on the Validation of Alternative Testing Methods (ICCVAM), was been established in the U.S. in May, 1997 as an offshoot of the Food and Drug Administration (FDA). The goal of this organization is also to facilitate development and application of new test methods, and improve animal welfare by finding alternatives to animal testing.

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