Non-Standard Laboratory Services

What is the biological relevance of the results obtained from the standard battery of tests? Are the test compound, its metabolites, degradation products and/or impurities DNA reactive? These questions will need to be answered for regulatory submissions even if the standard tests aren't capable of addressing them.

Helix3 conducts DNA reactivity dose response curve studies exposing nuclear human DNA to a test compounds thereby eliminating the cellular requirements and functions that contribute to the poor specificity/sensitivity of most in vitro assays. This allows for the assessment of DNA reactivity and the determination of various forms of DNA damage all in the absence of cytotoxicity, repair, or cell line differences and without the requirements for cellular division.

Requiring minimal amounts of chemical, our protocol can be used to screen compounds during the early stages of development when manufacturing and resources are limited. It can also be used to understand mechanisms which may contribute to positive findings in the standard battery of in vitro tests and/or to determine the biological relevance of such findings. Conducted according to GLP requirements, our DNA reactivity data can also be included to supplement regulatory submissions.

The acute in vivo comet assay can also be utilized to screen compounds and minimize the use of longer term toxicology studies by providing the sensitive and early detection of potentially mutagenic events that can lead to tumorigenesis in target organs.

Using fewer animals, an exposure period of <3 days, and less toxic or more clinically relevant doses than a subacute or chronic toxicology study, the acute in vivo comet assay provides a cost effective method for reducing the use of animals. When comet is implemented during the screening phase of development, positive results can be used to prevent further development expenditures and/or to make adjustments to the development process. Negative results can provide additional assurance to proceed with development and the data can be included later in regulatory submissions.