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Regulatory testing

Genetic toxicology is a significant field within the regulatory testing of compounds for national and international authorities.Within regulatory testing, it is essential to follow the principles of GLP and have excellent laboratory traceability and data management.  This traceability should extend to include your software systems also.

Micronucleus test & comet assay

Routinely, the micronucleus test is used as the first in vivo or in vitro test when investigating the genotoxic potential of a compound.   According to the ICH S2(R1) guidelines, this can be followed by a number of other tests, such as the comet assay and chromosome aberration test.

To ensure that your studies are performed in a robust, GLP compliant manner, consider using Cyto Study Manager.  Cyto Study Manager is a secure, web-based, GLP compliant system that integrates the data acquisition, reporting and management of your genetic toxicology data.  Comet assay data can be integrated directly from our world class scoring software, Comet Assay IV.

If you are doing combination studies (such as comet assay and micronucleus test), Cyto Study Manager can help you with the work load! For example, you would design one study layout, and only have to enter your treatment groups and sample information once, but have two separate assays conducted on the same hosts. The Cyto Study Manager can treat this as one study, or several studies should you wish, and can generate customised reports for your application, ultimately saving you time and money.

The Cyto Study Manager can be used for both in vitro and in vivo investigations; a single module (such as the comet assay module) will store data and experimental information from both types of investigations.  Cyto Study Manager modules are tailored to the requirements of each specific GeneTox assay using the regulatory guidelines, such as OECD and ICH S2(R1).

Ames Test

The Ames test is often used within multi-dimensional genetic toxicology studies which form part of a regulatory testing investigation, such as REACH.

Perceptive Instruments are able to offer a suite of products used by laboratories conducting the Ames Test to regulatory guidelines (e.g. ICH S2(R1), OECD 471).  Our world-renowned Sorcerer Colony Counter is able to effortlessly and automatically determine the number of bacterial colonies per plate and Ames Study Manager can be used to effectively manage the data generated within Ames test investigations. Ames Study Manager has been designed to work alongside protocols developed to regulatory guidelines. It is used in pharmaceutical, medical and chemical companies as well as contract research organisations.

Sorcerer Colony Counter and Ames Study Manager are clearly the products of choice for conducting the Ames Test. The combination of one of the most powerful and flexible image analysis systems on the market, with the most versatile and well-regarded study management system, gives unparalleled data control, perfect for those labs wanting to maintain high standards of GLP.

Unscheduled DNA Synthesis (UDS)

The UDS remains a popular assay for determining DNA strand breakages. It is often an accepted second genetic toxicology method because the OECD guidelines (both in vivo and in vitro) have been issued.

UDS is a recommended genetic toxicological technique in the ICH S2(R1) guidelines which details occasions when it is suitable.   Within the field of genetic toxicology, UDS has a clear niche.  The rat liver UDS test is viewed as complementary to the micronucleus test, and a combination of the two is generally considered likely to detect the majority of genotoxic compounds.

Sorcerer UDS consists of a series of modules for creating studies, randomisation, slide scoring, data saving and production of experimental summaries. Slide scoring can be based either on direct or indirect counts and the analysis of one or more cytoplasmic areas.

Contract research organisations, and other laboratories, performing high through-put UDS studies have chosen to invest in Sorcerer UDS.  Sorcerer UDS is the only automatic image analysis system available on the market designed specifically for the UDS assay.  Sorcerer UDS has flexible study design and interactive scoring techniques, making it the product of choice for those performing UDS.

GLP and regulatory compliance

All systems from Perceptive Instruments comply with GLP guidelines and the FDA 21 CFR Part 11 Final Rule on Electronic Records & Electronic Signatures.  Our software boasts exceptional database security and excellent flexibility in data entry configuration.

In addition, raw data is encoded and secure, and all audit trail files are automatically saved.  Our systems haves the ability to request secure passwords from users for a number of actions throughout the system.   Users can be prompted to justify all auditable actions in a customised manner, resulting in a robust, but adaptable, approach to achieving compliance.

More about REACH

REACH is the European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of CHemical substances. The law came into force on 1 June 2007 with the sole aim of placing greater responsibility on industry to protect human health and the environment. The number of scientific facilities offering genetic toxicology services for REACH testing is steadily expanding.

The 31st of May 2013 is the deadline for industry to register all phase-in substances manufactured or imported in the EU above 100 tonnes a year under REACH. Enforcement of REACH and CLP (Classification, Labelling and Packaging of chemical substances & mixtures) is undertaken by national authorities to verify the compliance of the duty holders with REACH and CLP Regulations. This includes checking whether the substance has been registered or pre-registered or verifying the presence and correctness of the Safety Data Sheets.

REACH requires that studies should be conducted in a Good Laboratory Practice (GLP) accredited laboratory, and in addition, the REACH initiative strives to minimise the number of animal tests. The REACH regulation provides a number of possibilities to adapt the testing requirements and to use alternative assessment approaches.

References

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