Biocompatibility & Genotoxicity Assays
Ensure the safety of medical devices, drugs, and cosmetics using our in vitro assays to determine biocompatibility and genotoxicity of materials and devices.
Featured assays
Genotoxicity
Genotoxicity, the ability of a chemical agent to damage DNA resulting in mutations, is a required component across pharmaceuticals, chemicals, and personal care products. Genotoxic compounds induce DNA damage in the form of deletions, and single- or double-stranded breaks which, if unrepaired, can lead to cell death, cancer, or other adverse effects.
LifeNet Health LifeSciences performs two assays for the assessment of potential genotoxic effects of test compounds: the Ames bacterial reverse mutation test (OECD 471) and the in vitro mammalian cell micronucleus test (OECD 487). Learn more about each method below.
Hemocompatibility
Hemocompatibility assesses the potential for a device or chemical to induce hemolysis or alter normal blood clotting times.
LifeNet Health LifeSciences offers multiple in vitro assays to assess hemocompatibility of test compounds or devices tested using high-quality, donated and consented human (or other species) blood, serum, and/or PBMCs. Learn more about each method below.
In Vitro Hemocompatibility Assays:
• Hemolysis/Hemoglobin Denaturation Assay
• Prothrombin Time Assay
• Activated Partial Thromboplastin Time Assay
• Immunostimulation Assay
• Platelet Activation Assay
• Complement Activation Assay
Inflammatory Response
Inflammation is the body’s natural response to injury or infection, but when it becomes chronic it can damage healthy cells and tissues.
LifeNet Health LifeSciences offers customized in vitro assays to assess inflammation resulting from exposure to test compounds or devices. Examples of markers that can be measured include IL-1α, IL-6, IL-8, TNF-α, TNF-ß, and more. Our team can tailor testing to detect inflammatory markers specific to your project.
Common Assays We Offer
Biocompatibility and Genotoxicity Assays
Biocompatibility and genotoxicity testing are a vital part of ensuring the safety of medical devices. These assays are also required as part of the regulatory submission process for cosmetics and drugs in the United States, Canada, and the European Union. Biocompatibility tests measure cytotoxicity, sensitization, and irritation.
Our assay services team can support these efforts with in vitro assays, many of which are accepted as full replacement models following ISO 10993 and OECD Testing Guidelines, helping to reduce reliance on traditional animal testing.
Why partner with LifeNet Health® LifeSciences for your medical device testing?
Our experienced team is committed to helping you identify and customize safety studies that accurately assess your medical device using methods based on current regulatory guidelines.
Our expansive services portfolio includes standardized methods as well as advanced methodologies only available to our partners. Our ability to utilize directly sourced, high-quality human tissues sets us apart, enabling medical device assessments that more accurately reflect human biology.
Our assay services team is committed to performing biocompatibility studies and delivering high-quality data with timely turnaround—at every stage of your project.
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