Genotoxicity Evaluation

Genotoxicity is the property of chemical agents that damage the genetic information within a cell causing mutations, which may lead to cancer. This permanent, heritable change affects both the somatic cells of the organism and the germ cells that are passed on to offspring. Generally, researchers assay genotoxic molecules by analyzing DNA damage in cells exposed to toxic substrates. These DNA damage can be in the form of single- and double-strand breaks, loss of excision repair, cross-linking, alkali-labile sites, point mutations, and structural and numerical chromosomal aberrations. Alfa Chemistry is an expert in drug evaluation. Our specialized nonclinical evaluation technology platform provides technical support for the genotoxicity evaluation of oligonucleotide therapeutics.

Genotoxicity Testing

Oligonucleotides are considered synthetically manufactured drugs by most regulatory agencies and are therefore required to undergo a full battery of genotoxicity tests. Common genotoxicity tests are as follows:

In vitro assay for "point" mutations involving one or a few base pairs: the Ames microbial mutagenicity test is a widely used assay to assess the mutagenic potential of chemical compounds. The test is selected because of its historically high positive predictability for rodent carcinogens.

In vivo rodent assay for chromosomal damage: the most typical assay is the bone marrow micronucleus assay or chromosomal assay. The in vivo assay is needed because certain genotoxic carcinogens are known to be detectable only in vivo genotoxicity assay.

What We Offer?

With experienced experts and state-of-the-art equipment, Alfa Chemistry is able to provide customers with genotoxicity evaluation services and related technical advice for oligonucleotide therapeutics. We are committed to:

Our products and services are for research use only and cannot be used for any clinical purposes.

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