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Companion Diagnostic Immunoassays

A companion diagnostic is a medical device which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks. This could be by identifying patients who are most likely to benefit from a particular therapeutic product; identifying patients likely to be at increased risk for serious side effects; or monitoring response to treatment. If the diagnostic test is inaccurate, then the treatment decisions based on its data may not be optimal.

Example Project

Client's companion diagnostic strategy informed by Fleet's analysis

A North American company intended to market a novel therapeutic for Alzheimer's disease, and approached Fleet to help commercialise a companion diagnostic for the relevant receptor protein. Careful work by Fleet's experts highlighted performance issues with the diagnostic approach, informing the client's strategy with respect to this assay.

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