about-helix3-IT and quality

Monday December 6, 2009

Helix3 Publishes Combining the in vivo comet and micronucleus assays: a practical approach to genotoxicity testing and data interpretation to Address New ICH S2(R1)Guidelines

To address the recent S2(R1) modifications to the ICH Guidelines, Marie Vasquez published the most innovative protocol for combining the in vivo comet and micronucleus assays in Mutagenesis today. Using real study data, this publication provides for the first time and in explicit detail recommendations for study design, addressing cytotoxicity, and data interpretation in the comet assay. The complete article including supplemental figures is available free online at Mutagenesis.

Friday October 30, 2009

Helix3 Develops and Presents the Acellular Comet Assay as an Alternative In Vitro Testing Strategy Designed to Reduce In Vivo Requirements

Helix3 has developed an acellular comet assay protocol In response to the concern that cytotoxic doses in the in vitro standard battery of tests lead to "false positive" results requiring unnecessary animal testing. Unaffected by cytotoxicity, cell division, repair, and/or cell type, the acellular comet assay provides a quick and easy means for determining whether a compound directly interacts with DNA and may provide better concordance to the comet assay in target organs.

The acellular comet assay combined with In vitro comet in live cells (either dividing or non-dividing) may also provide valuable mechanistic data that could otherwise go undetected for many test compounds. In doing so, this testing strategy could minimize the need for in vivo studies and/or provide opportunities for optimizing regulated study designs.

January 2009

Guenter Speit, Andreas Hartmann, and Marie Vasquez Publish The comet assay as an indicator test for germ cell genotoxicity in Mutation Research

Helix3 historical control data for several sex-specific tissues (e.g. mammery and prostate glands), portions of the endocrine system (e.g. pituitary and hypothalamus glands) as well as data from germ cells were published to demonstrate how the comet assay may be utilized for detecting genotoxicity in cells or tissues that may be directly or indirectly affected by endocrine disruption which can lead to sex-specific cancers and other health affects.