Companion Diagnostics
QAEC Limited is your trusted partner and expert in companion diagnostics, with decades of hands on practical expertise of working in the life science industry. Bringing a product from development to market can be challenging, which is why it is crucial to have expert support throughout the development life cycle for your Companion Diagnostic (CDx).
Companion Diagnostics Regulatory Compliance
Companion diagnostics refer to medical tests, which are categorised as medical devices and fall under In Vitro diagnostic (IVD) medical devices. These devices provide essential information for the safe and effective use of a corresponding drug or biological product.
Companion diagnostics can:
- Identify patients who are most likely to benefit from a specific therapeutic product.
- Identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product.
- Monitor the response to treatment with a specific therapeutic product to adjust the treatment for improved safety or effectiveness.
There is a growing demand for personalised medicine
Companion diagnostics play a crucial role in personalised medicine by testing for specific biomarkers, such as genetic mutations or protein levels, linked to a particular disease or the response to a specific treatment.
Physicians rely on the results of these tests to make informed decisions about which treatments are most likely to be effective for individual patients. This approach represents a significant shift towards tailoring medical treatments to each patient’s specific needs.
Companion diagnostics regulatory requirements
The regulations governing companion diagnostics vary depending on the specific country or region in which they are being marketed.
In general, companion diagnostics are subject to regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulations ensure that companion diagnostics meet certain standards for safety, efficacy, and quality before they can be marketed and used in clinical practice.
Regulations for companion diagnostics in the United States
In the United States, companion diagnostics are regulated as In Vitro diagnostic (IVD) devices by the FDA’s Center for Devices and Radiological Health (CDRH).
The FDA evaluates companion diagnostics to ensure that they are safe, effective, and reliable for use in guiding treatment decisions. The FDA also requires that companion diagnostics be developed and validated in accordance with established scientific principles and good manufacturing practices.
Regulations for companion diagnostics in the European Union
In the European Union (EU), companion diagnostics are regulated as medical devices under the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).
The regulations mandate that companion diagnostics must meet specific standards for safety, performance, and clinical evidence before they can be placed on the market. The MDR and IVDR also stipulate that manufacturers of companion diagnostics must implement a Quality Management System (QMS).
Whether you need regulatory assistance for your existing device, or you are considering launching a new companion diagnostic device but are unsure how to manage compliance, contact us today at +44 (0)1452 341913 or email us at enquiries@qaeclimited.co.uk to discuss your situation, as we have the expertise to support your product in meeting the specific regulatory requirements of your target markets.
QAEC Limited can provide the support and guidance that you need as your regulatory partner at every level. Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.
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