Molecular Diagnostics Services, Inc.
A Contract Research Organization

MDS offers a series of in vitro and in vivo Tests for Genetic Toxicity


FDA recommends the use of a battery of short-term genetic toxicity tests for all when the cumulative estimated dietary intake exceeds 1.5 µg per person per day, corresponding to 0.5 parts per billion (ppb) in the total diet. It is essential that chemicals be evaluated for their ability to induce both gene mutations and chromosomal aberrations.

Genetic changes known to be associated with adverse human health effects include gene mutations, chromosomal rearrangements or deletions, and loss or gain of whole chromosomes (aneuploidy) or chromosomal segments. Cytogenetic analysis provides a valuable technique for evaluation of damage to chromosomes on the basis of direct observation and classification of chromosomal aberrations. The cytogenetic assays may be performed either in vivo or in vitro . In vitro cytogenetic assays are performed in the presence and absence of exogenous metabolic activation systems (S9).
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