Helix3 Develops In Vivo Comet Crosslinking Positive Control
To facilitate evaluating for in vivo DNA crosslink induction that can lead to clastogenicity and/or aneuploidy in tissues that cannot be evaluated with the chromosome aberration or micronucleus assay, Helix3 has developed a method for easily incorporating a crosslinking positive control into any in vivo comet assay study design. This innovative method requires no additional animals and minimal additional effort and cost while substantially enhancing the data generated from
Helix3 Describes What Can Cause False Positive Comet Assay Results
The Helix3 publication "Reducing risk of false positive in the in vivo comet assay and improving result reliability" describes three in vivo comet assay studies in which three different laboratories generated false positive results. All three positive results were overturned by regulatory authorities when Helix3 repeated the studies and generated negative results using our standard methods incorporated to minimize procedural bias and variability.
IWGT Comparison of Comet HCD Data Highlights Superior Helix3 Quality
The 2023 publication of Assessing the quality and making appropriate use of historical control negative data: A report of the...
FDA Inspects Helix3 With No Findings
The U.S. Food & Drug Administration Bioresearch Monitoring Program reports no findings following an onsite inspection of Helix3 in April...
Helix3 Initiates HESI/GTTC Comet Project
Comet Expert Marie Vasquez is leading the HESI/GTTC Comet Project to make practical recommendations for improving the clarity and...
Manual for Conducting Regulated In Vivo Comet Assay Studies Published by Helix3
Marie Z. Vasquez (Helix3) and Roland Frötschl (BfArM) co-authored the In Vivo Comet Assay Test Book Chapter in the Genetic Toxicology...
Comet Mobile Unit Goes Where It's Needed
The Helix3 comet mobile unit travels to any test site within the US or Europe to provide onsite GLP comet sample processing and analysis...
Helix3 participates as expert panel member at the IWGT on the comet assay in Brazil
When the International Workshop on Genotoxicity Testing met in Iquazu Falls, Brazil to discuss the critical issues for the comet assay,...
Acellular Comet Detects DNA Reactivity
In response to regulatory requests for DNA reactivity data, Helix3 developed the acellular comet assay with positive controls for...
OECD TG 489 Prompts More Regulatory Requirements for the In Vivo Comet Assay
With the adpotion of OECD TG 489 for the in vivo comet assay, FDA, ECHA and EFSA regulators are poised and ready to require more comet...
