definiens: means any product or service that(a ) identifies a person having a disease or condition, or a molecular genotype or phenotype that predisposes a person to suchdisease or condition, for which a Molecule could be used to treat and/or prevent such disease or condition;(b ) defines the prognosis or monitors the progress of a disease or condition in a person for which a Molecule could be used totreat and/or prevent such disease or condition;(c ) is used to select a therapeutic or prophylactic regimen, wherein at least one ( 1 ) potential therapeutic or prophylactic regimeninvolves a Molecule, and where the selected regimen is determined, based on the use of such product or service, to likely be effective and / orto be safe for a person ; and / or(d ) is used to confirm a Molecule ’s biological activity and/or to optimize dosing or the scheduled administration of a Molecule