STEMart, a U.S.-based provider of comprehensive services for medical device development, has expanded its biocompatibility testing portfolio with the In Vivo Mouse Micronucleus Test. This new service helps medical device manufacturers identify potential genotoxic risks and ensure compliance with international regulatory standards including ISO 10993-3 and OECD Guideline No. 474.
Environmental mutagens may induce chromosomal mutations through various mechanisms, leading to serious health hazards. Genotoxicity assessment is typically required in chemical safety evaluations, and the in vivo micronucleus test receives more emphasis than other toxicological endpoints. The purpose of the micronucleus test is to identify substances that cause cytogenetic damage, resulting in micronuclei containing chromosomal fragments or entire chromosomes.
This assay is an in vivo cytogenetic test that analyzes red blood cells from rodent bone marrow to detect damage to mammalian cell chromosomes or the mitotic apparatus caused by chemicals. During the development of erythroblasts into polychromatic erythrocytes in bone marrow, the primary nucleus is expelled, potentially leaving a micronucleus in the nucleolus-free cytoplasm. Chromosomal damage manifests as minute extra-nuclear bodies that are clearly identifiable under an optical microscope. An increased incidence of micronucleated polychromatic erythrocytes in treated animals indicates genotoxicity.
With the accelerating pace of medical device innovation, the need for reliable genotoxicity assessment is more pressing than ever. Based on OECD Guidelines for Testing of Chemicals, Test No. 474, the in vivo mouse micronucleus test evaluates the presence of micronuclei in red blood cells that contain chromosomal fragments or whole chromosomes. STEMart now offers this test to detect potential cytogenetic damage to red blood cell chromosomes or the mitotic apparatus caused by medical devices. Manufacturers can conduct this testing under Good Laboratory Practice or non-GLP conditions to identify potential mutagens or carcinogens early in the development process.
STEMart is committed to being a one-stop provider for medical device testing, offering seamless continuity from initial biocompatibility screening to final clinical validation. By integrating in vivo mouse micronucleus testing into its service portfolio, STEMart provides clients with comprehensive final reports that include methodology, raw data, analysis, and result interpretation. This empowers developers to effectively mitigate risks. Additionally, by conducting in vivo mouse micronucleus tests under both GLP and non-GLP conditions, STEMart provides clients with the flexibility and scientific rigor necessary to meet global regulatory requirements.
STEMart offers medical device manufacturers comprehensive assays to ensure patient safety and meet stringent international regulatory requirements. For more information about STEMart's genetic toxicology services and the In Vivo Mouse Micronucleus Test, please visit https://www.ste-mart.com/in-vivo-mouse-micronucleus-test.htm.
