In Vivo Mammalian Alkaline Comet Assay
The comet assay, also known as the single-cell gel electrophoresis (SCGE) assay, measures DNA strand breaks in individual cells.
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Additional Support and Regulatory Follow-Up
When standard genetic toxicology assays return positive results, additional assays may be required to determine mechanism of action and qualify human risk.
- The comet assay, also known as the single-cell gel electrophoresis (SCGE) assay, measures DNA strand breaks in individual cells.
- Appropriate tissues are collected and processed to a single-cell suspension layered over a slide in a thin film of agarose.
- Electrophoresis is then performed to identify DNA damage by the migration of small fragments of broken DNA away from the nucleus forming a “tail” to the dense circular comet head of undamaged DNA.
- Testing is available for blood, liver, kidney, lung, bronchoalveolar lavage cells, stomach, duodenum, intestine, bone marrow, nose and eye.
- New tissues can be validated upon request.
When to Perform
- IND-enabling studies
- As part of the ICH S2(R1) standard battery (Option 2)
- As a follow-up to a positive in vitro mammalian cell clastogenic response
- REACH requirements
- As a follow-up to a positive result in an Annex VII or VIII genotoxicity test
Comet quantification on liver cell of rat treated with ethyl methanesulfonate