Carcinogenicity Testing
Ensure the life-long safety of your medical device. Our carcinogenicity assessments provide critical data on the potential for long-term material exposure to induce neoplastic changes, securing patient safety and regulatory approval.
Carcinogenicity testing is the most comprehensive assessment of a material’s long-term biological safety. Its purpose is to determine the potential of a medical device—or its leachable components—to induce tumors after chronic exposure. Given the high stakes of patient safety and the complexity of these studies, EBI provides expert guidance and testing protocols aligned with ISO 10993-3 and global carcinogenic risk management frameworks.
When is Carcinogenicity Testing Required?
According to ISO 10993-1, carcinogenicity must be addressed for devices with permanent contact (longer than 30 days). However, a full in vivo bioassay is not always the first step. Evaluation is typically triggered when:
- Chemical Characterization reveals the presence of known or suspected carcinogens.
- Genotoxicity results are positive or equivocal, suggesting potential DNA damage.
- Structural Activity Relationship (SAR) analysis indicates a chemical structure associated with carcinogenic potential.
- Historical Data on the materials is insufficient to rule out long-term risks.
Our Approach: The Tiered Evaluation Strategy
Carcinogenicity is a complex endpoint that requires a strategic approach to balance animal welfare, cost, and safety data.
1. Toxicological Risk Assessment (TRA)
Before physical testing, our toxicologists perform a deep-dive analysis of your device’s chemical profile. If the levels of leachables are below recognized Thresholds of Toxicological Concern (TTC), we can often provide a scientific justification to waive in vivo testing.
2. In Vitro Cell Transformation Assays (CTA)
As a modern alternative to long-term animal studies, we offer cell transformation assays. These studies observe whether a test substance can induce phenotypic changes in cultured mammalian cells, serving as a reliable indicator of carcinogenic potential.
3. In Vivo Carcinogenicity Bioassays
If required by regulatory bodies, we facilitate long-term in vivo studies designed to observe the animal for a major portion of its life span. These studies evaluate:
- Total tumor incidence and type.
- Time to tumor onset.
- Multiplicity and malignancy of any observed growths.
Standards & Regulatory Compliance
EBI’s protocols are designed to satisfy the most demanding international standards:
- ISO 10993-3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
- OECD Test Guidelines (451/453): International benchmarks for carcinogenicity and combined chronic toxicity studies.
- MDR 2017/745: Essential data for the technical file of high-risk (Class III) and long-term implantable devices.
Why Partner with EBI for Carcinogenicity?
- Modern Laboratory Infrastructure: We utilize high-resolution analytical tools (GC-MS, LC-MS) for the initial chemical screening that often precludes the need for animal testing.
- Expert Toxicologists: Our team includes board-certified toxicologists who specialize in translating complex chemical data into regulatory-ready safety conclusions.
- Risk Management Focus: We don’t just provide data; we provide a clear strategy to address carcinogenic risk while minimizing time-to-market and unnecessary testing costs.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: Frequently Asked Questions
Does every permanent implant require a 2-year carcinogenicity study?
Not necessarily. Many devices can be cleared based on thorough Chemical Characterization (ISO 10993-18) and a robust Toxicological Risk Assessment. If the materials have a long history of safe clinical use, a rationale for non-testing can often be established.
What is the link between Genotoxicity and Carcinogenicity?
Genotoxicity tests (like the AMES test) look for DNA damage, which is often the first step in the development of cancer. While most carcinogens are genotoxic, some „non-genotoxic” carcinogens work through other biological pathways, which is why a dedicated assessment is required.
Does every permanent implant require a 2-year carcinogenicity study?
Not necessarily. Many devices can be cleared based on thorough Chemical Characterization (ISO 10993-18) and a robust Toxicological Risk Assessment. If the materials have a long history of safe clinical use, a rationale for non-testing can often be established.
What is the link between Genotoxicity and Carcinogenicity?
Genotoxicity tests (like the AMES test) look for DNA damage, which is often the first step in the development of cancer. While most carcinogens are genotoxic, some „non-genotoxic” carcinogens work through other biological pathways, which is why a dedicated assessment is required.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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