NEW YORK, NY, February 10, 2026 /24-7PressRelease/ -- STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the expansion of its comprehensive biocompatibility testing portfolio with the In Vivo Mouse Micronucleus Test. This new service will help medical device manufacturers to 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 is given more emphasis than other toxicological endpoints. The purpose of the micronucleus test is to identify substances (liquid or solid) 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 (MN PCEs) 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 GLP (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.

About STEMart

STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.

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