With almost 25 years of experience and over 75 skillful employees, we are dedicated to offer you our services towards successful assay development. Our profound expertise makes Future Diagnostics a trusted partner for the development of your Companion Diagnostics. This can also be part of your personalized medicine, precision medicine, or as complementary diagnostics.
What are Companion Diagnostics?
A Companion Diagnostic (CDx) is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. It is usually part of personalized medicine or precision medicine. A Companion Diagnostic test assists a health care professional to determine whether a therapeutic product is beneficial to patients and will outweigh any potential serious side effects or risks. In other words, it is a tool to provide the right drug for the correctt patient, at the right time and in the right doses.
Therefore, a Companion Diagnostic should:
• identify patients who are most likely to benefit from a therapeutic product;
• identify patients likely to be at increased risk for serious side effects as a result of treatment with a therapeutic product; or
• monitor response to treatment with a therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.
That means that if a Companion Diagnostic is inaccurate, the decisions during treatment of a patient may not be optimal.
How we can assist you?
We can develop a Companion Diagnostics for your drug. In essence what we do is, first choose an assay format, collect the right components, and put together a good working protocol. Each assay format requires different numbers and varieties of components and offers a different level of detection capability, specificity, precision, and accuracy.
To ensure that test results are robust and accurate, we will systematically adjust and test all components and variables to optimize the assay. It is likely that there may not be a suitable critical reagents (i.e. antibodies) available and therefore need to be generated.
To ensure highest quality, conformity and transparency, we apply our proven New Product Development Process to all assay developments. Naturally, EN 13612:2002 and EN ISO 23640:2015 requirements and applicable CLSI guidelines are incorporated in this process, as is writing part of the Technical File.
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