STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the availability of its robust In Vitro Micronucleus Test service to meet the genotoxicity testing requirements for medical devices. This essential assay helps manufacturers to ensure the safety and biocompatibility of their products in compliance with international standards.
The in vitro micronucleus (MNvit) test is a genotoxicity assay that detects micronuclei in the cytoplasm of interphase cells. Micronuclei can originate from acentric chromosome fragments (i.e. fragments lacking centromeres) or entire chromosomes that fail to migrate to the cell poles during metaphase. The assay quantifies the clastogenic and chromosomal aberration-inducing activity of test substances in cells undergoing mitosis during or following exposure to the substances. It can also serve as an alternative to chromosome aberration tests. As it examines interphase cells, micronucleus assessment enables faster scoring due to the fact that damage analysis is considered to be less subjective and more amenable to automation.
The in vitro micronucleus assay is an established method for quantifying DNA damage and is mandated by global regulatory authorities for screening chemical genotoxicity. There are two approaches to conducting the micronucleus test: counting micronuclei in mitotically arrested binucleate cells or counting them directly in non-arrested mononuclear cells. Various micronucleus counting methods have been developed, including manual and automated microscopy and conventional flow cytometry.
STEMart now offers In Vitro Micronucleus Test service that adheres to the OECD Guidelines for Testing of Chemicals, Test No.487, to determine whether a medical device is genotoxic to cells in culture. This assay is available under either GLP (Good Laboratory Practice) or Non-GLP conditions, utilizing relevant cell lines such as Human Peripheral Blood Lymphocytes (HPBLs), TK6 Human Lymphoblastoid cells, and Chinese Hamster Ovary cells.
STEMart’s MNvit service provides a thorough evaluation of the chromosomal damage potential of agents that can induce either chromosomal loss or breaks within a single endpoint assay. The assay offers enhanced sensitivity through the combined staining of telomeres and centromeres, which enables differentiation between aneuploidy and breakage inducers. Furthermore, as the assay is conducted during interphase, micronucleus evaluation is accelerated. Automated scoring via flow cytometry streamlines the entire process for greater efficiency.
Upon completion, STEMart will provide a detailed final report to clients, including the methodology, raw data, analysis, and interpretation of the results. The company is currently offering special promotions on all testing services, including the MNvit. To learn more about these services and other medical device testing solutions, or to consult with the experts at STEMart, please visit https://www.ste-mart.com/in-vitro-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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Website: https://www.ste-mart.com/