Genetic toxicology

Genotoxicity studies can predict the genotoxic effects of drugs and chemicals, including mutagenicity, clastogenicity, and DNA damage. We offer all assays included in the ICH S2(R1) standard battery and comply with international GLP regulatory guidelines. Our assay protocols are designed to meet the requirements of guidance documents issued by the U.S. FDA, U.S. EPA, ICH, OECD, and CFDA. Years of accumulated extensive historical control databases, a stable technical team, and highly qualified senior researchers ensure that we can provide our clients with high-quality services promptly and effectively. We are committed to developing cutting-edge genotoxicity methodologies and applying automated systems such as flow cytometry to genotoxicity research. We have participated multiple times in collaborative validation studies of new genotoxicity technologies and methods both domestically and internationally. In addition to the ICH standard assay battery, we can also provide clients with studies on genotoxicity mechanisms and additional assay methods, as well as genotoxicity assessments of impurities that meet the requirements of ICH M7.

Genetic toxicology

Genotoxicity studies can predict the genotoxic effects of drugs and chemicals, including mutagenicity, clastogenicity, and DNA damage. We offer all assays included in the ICH S2(R1) standard battery and comply with international GLP regulatory guidelines. Our assay protocols are designed to meet the requirements of guidance documents issued by the U.S. FDA, U.S. EPA, ICH, OECD, and CFDA. Years of accumulated extensive historical control databases, a stable technical team, and highly qualified senior researchers ensure that we can provide our clients with high-quality services promptly and effectively. We are committed to developing cutting-edge genotoxicity methodologies and applying automated systems such as flow cytometry to genotoxicity research. We have participated multiple times in collaborative validation studies of new genotoxicity technologies and methods both domestically and internationally. In addition to the ICH standard assay battery, we can also provide clients with studies on genotoxicity mechanisms and additional assay methods, as well as genotoxicity assessments of impurities that meet the requirements of ICH M7.

Experimental system

Cells: CHL, CHO, TK6, L5178Y, 3T3, etc. (purchased from ATCC)

S9 (purchased from MOLTOX)

Strain (purchased from MOLTOX):

—Salmonella typhimurium: TA97a, TA98, TA100, TA102, TA1535, TA1537

—Escherichia coli: E. Coli WP2 uvrA and E. Coli WP2 uvrA (pKM101)

 

Core Combination Test

Ames Test (OECD 471)

In Vitro and In Vivo Chromosome Aberration Tests (OECD 473/475)

Gene Mutation Assay (MLA, HGPRT, or XGPRT) (OECD 490/476)

In vitro and in vivo micronucleus assays (Manual & FCM) (OECD 487/474)

Comet Assay IV Software for In Vivo Multi-Organ Comet Assay (OECD 489)

 

Additional Trials/Mechanism Studies

In Vitro and In Vivo Pig-a Gene Mutation Assays

Multi-endpoint genotoxicity assay (γ-H2AX, p53, H3, Cleaved-PARP)

In vivo liver micronucleus assay