-- STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the launch of its In Vitro Chromosome Aberration Test service. This critical genetic toxicology assessment is essential for manufacturers seeking global regulatory clearance by evaluating the clastogenic potential of medical devices and materials.
Genotoxicity testing involves evaluating the risk that test substances will induce gene mutations or chromosomal damage, using multiple in vitro and in vivo bacterial and mammalian cell testing systems. As a specialist in the medical device services sector, STEMart offers a range of diverse genotoxicity and biocompatibility testing solutions, including the Bacterial Reverse Mutation Test (Ames) and the In Vitro Mouse Lymphoma Assay TK. These solutions are designed to meet the varied testing needs and requirements of clients. STEMart strictly adheres to OECD guidelines revised for the medical device sector and conducts testing under Good Laboratory Practice (GLP) conditions.
The In Vitro Chromosome Aberration Test is performed according to the rigorous standards of OECD Guideline for the Testing of Chemicals, Test No. 473, and is a core requirement within the ISO 10993-3 biocompatibility standard. The aim of this assay is to identify chromosomal structural abnormalities, including deletions, breaks and exchanges, that could potentially be induced when extracts from medical devices come into contact with mammalian cells. The results of this test provide critical data for assessing the genetic safety of new products.
STEMart now offers in vitro chromosome aberration testing to evaluate the ability of medical devices to cause structural aberrations in mammalian cell chromosomes. This testing can be conducted under GLP (Good Laboratory Practice) or non-GLP conditions. The assay can be performed using either human pulmonary alveolar epithelial cells (HPBLs) or established cell lines, such as Chinese hamster ovary (CHO) cells. This test is applicable to medical devices intended for permanent or long-term patient contact, or for contact with blood.
The testing can be conducted in two ways, including the short-term exposure (4 hours) with metabolic activation (S9) conditions, or long-term exposure (21 or 24 hours) without S9 conditions. Manufacturers can use this approach to comprehensively evaluate potential mutagenic effects. In addition, GLP-compliant and non-GLP options are available to meet diverse client requirements. STEMart also provides the final report that includes the detailed methodology, the raw data and expert interpretation to clients, supporting manufacturers to meet the regulatory goals and minimize the compliance risks.
STEMart offers the chromosomal aberration test to evaluate whether a medical device compound could cause chromosomal abnormalities. 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-chromosome-aberration-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.
Contact Info:
Name: Staci Horme
Email: Send Email
Organization: STEMart
Website: https://www.ste-mart.com/
Release ID: 89176671
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