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STEMart Launches Genetic Toxicology Testing Services for Medical Devices

STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now introduces multiple medical device genetic toxicology testing services following the OECD guidelines modified for medical devices and performing under GLP conditions.

Genetic toxicology testing evaluates the potential of the test material to induce the gene mutation or chromosome damage using a range of bacterial, mammalian cells in vitro and in vivo test systems. STEMart offers many test types for genotoxicity biocompatibility testing, and this new genetic toxicology testing is an addition to its portfolio, which includes Bacterial Reverse Mutation Test (Ames), In Vitro Mouse Lymphoma Assay TK, In Vitro Chromosome Aberration Test, and Micronucleus Assay.

STEMart offers comprehensive services for genetic toxicology testing. For instance, the Bacterial Reverse Mutation Test (Ames) is used to evaluate the potential mutagenic activity of the materials extracted from a medical device. The Bacterial Reverse Mutation Assay (Ames test) is performed to determine if the material leached from the medical device is mutagenic. Another example is the chromosomal aberration test, which is used to evaluate the potential of a medical device compound to cause structural chromosomal abnormalities, and the test can be performed in HPBLs or established cell lines, such as Chinese hamster ovary (CHO) cells. This test is performed on devices that have permanent or prolonged contact with patient, or blood contact.

STEMart also provides the mouse lymphoma assay, which is used to detect a battery of cell cultures, usually mammalian, to determine gene mutations, change in chromosome structure, and other gene toxicities induced by medical devices or extracts. This can help eliminate the risk of eliciting genotoxicity for medical devices that have prolonged contact with patients.

"We also perform the micronucleus test (MNT) to evaluate the genetic toxicity of a compound by assessing the presence of micronuclei, which can be achieved by In vitro micronucleus test, in vivo rat micronucleus test, and in vivo mouse micronucleus test." said Tina Frederick, Executive Director of Marketing at STEMart. "STEMart offers comprehensive services for your medical device development through all phases, from the initial ideation stage, through product design, development and validation up to manufacturing and launch. Our engineers, physicists, industrial designers, regulatory and manufacturing experts will work together with your team to ensure an optimal outcome." added Tina.

If you have additional questions about cytotoxicity or would like to find out more about the medical device genetic toxicology testing service, please visit

About STEMart

STEMart is an industry-leading eCommerce platform with an expanded global footprint and has a broad portfolio of more than 10,000 products. It aims to provide best-in-class 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 towards the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer, and through that to accelerate access to better health for people everywhere.

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Last Updated: 20-Jul-2021