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MULTIANALYTE ASSAYS WITH ALGORITHMIC ANALYSES

Multianalyte Assays with Algorithmic Analyses (MAAA)

Complex diseases with often unknown etiologies create serious challenges for physicians and their patients. Single tests and even batteries of test results don’t necessarily provide clinicians with effective tools for managing these patients.
Recent advances in clinical molecular diagnostic technologies coupled with biostatistical analysis have enabled the development of Multianalyte Assays with Algorithmic Analyses (MAAA).

MAAAs use multiple results derived from panels of analyses of one or more types. Algorithmic analysis using the results of these assays, sometimes in combination with other clinical information, leads to a single result that can be reported as a numeric score or as a probability. This may be a probability that a patient does or does not have a particular disease – often ending a long diagnostic journey as is the case with diseases such as SLE. Or it may represent the likelihood that a patient requires or does not require therapeutic intervention, or will/won’t respond to a particular form of therapy. These MAAA tests are exactly the types of significant advances that are the subject of the Precision Medicine Initiative, which was announced by the White House in 2015

MAAAs producing a single probability score must be validated in clinical trials against a clinical outcome (e.g., presence or absence of disease). Part of that validation includes the demonstration of improved clinical benefit relative to the individual tests

Today, many MAAAs are recognized as the standard of care for the diagnosis of certain conditions, or for the high-value prediction or monitoring of therapeutic response.