HELIX3
INC.
U.S. FDA Drug Safety Testing

ICH Safety Guidelines

European REACH Chemical Regulations

EMEA Guidance on Genotoxicity Testing of Medicines

Comet Assay Interest Group

U.S. Environmental Mutagen Society

Genetic Toxicology Association

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Our Services
GLP Laboratory Services
Helix3 performs all studies and services according to GLP requirements and with the highest scientific standards.  As a result, all of our data can be included with any regulatory submission package.
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Copyright© 2003-2012 Helix3 Inc.  All Rights Reserved
Comet Assay Studies
The Comet Assay is one of the fastest and most flexible resources available for assessing potential health risks.  Able to detect multipe forms of DNA damage in almost any cell type and under a variety of exposure conditions, safety testing with the comet assay requires critical assessment and customization of the study design to ensure the quality and defendability of the data.

Helix3 currently provides comet assay and combined comet / micronucleus assay studies evaluating DNA damage in the following tissues. 

Liver           Stomach      Adrenals          Sperm
Kidney        Duodenum   Hypothalamus  Ovary
Spleen        Colon           Thyroid             Prostate
Blood          Cecum          Pituitary           Mammary
Lung           Ileum             Pineal              Uterus
B.Marrow   Bladder        Pancreas        Testis
   
To faciltate the integration of the comet assay into ongoing toxicology or clinical studies, Helix3 also offers mobile comet laboratory and sample analysis services.
Screening / Mechanistic Studies
To evaluate the DNA reactivity and/or mode of action of test compounds, impurities, metabolites and/or degradation products, Helix3 designs and conducts a variety of non-standard studies to support drug development and safety testing requirements. 

Assay Development
Helix3 continuously strives to develop new assays and techniques  to enhance the understanding of standard test results and improve the efficacy of safety testing as new classes of compounds are developed.  Examples of our successes are currently incorporated in our standard protocols and services.

For more information about our customized services, please contact us.