OUR SERVICES

THE COMET ASSAY EXPERTS TAKE RESEARCH TO REGULATORY SUBMISSION

WHAT WE DO.

Helix3 customizes experimental designs and conducts all services according to the GLPs.  This minimizes the risk of false positive or unclear results while ensuring the dependability and reproducibility of the methods conducted.  As the acknowledged Comet Assay expert responsible for advancing Comet from a research tool to international regulatory acceptance, Helix3 has the expertise to help you with any of your research or regulatory submission needs.

REGULATED STUDIES

In Vivo Comet Assay

Conducted in any species/strain on any tissue:

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

Combined In Vivo Comet and Micronucleus Assay

Any comet tissue(s) and micronucleus evaluation of the bone marrow or peripheral blood from the same exposure unit

GLP RESEARCH SERVICES

Method Development

In vitro, in vivo, ex vivo  and/or clinical methods modified and optimized to accommodate specific exposure, application, or regulatory agency requirements

Screening Studies

In vitro DNA Reactivity Screening

In vivo target organ toxicity tests

Conducted to identify the best testing or development approach and to minimize the risk of unexpected positive safety testing results

Mobile Comet Assay

Conducted onsite at any client-specified facility, clinic or field site where our expertise is required to collect and process comet samples from any ongoing experiment, species or exposure condition

Investigative Studies

Weight-of-evidence (WoE) or mechanistic studies designed and conducted to answer a specific question or to further support a regulatory submission

Study Evaluation and Validation

Evaluation of previously conducted studies or experiments to determine the validity of the data,  identify optimization opportunities, and make recommendations for development progression

Experimental Design and Troubleshooting

Customized protocol development, troubleshooting, and method testing to achieve specific research or regulatory objectives