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.
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.