definiens: shall mean any product or service that:(a ) identifies a person having a disease or condition, or a molecular genotype or phenotype thatpredisposes a person to such disease or condition, for which a Product or Licensed Productcould 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 forwhich a Product or Licensed Product could be used to treat and/or prevent such disease orcondition;(c ) is used to select a therapeutic or prophylactic regimen, wherein at least one ( 1 ) potentialtherapeutic or prophylactic regimen involves a Product or Licensed Product, and where theselected regimen is determined, based on the use of such product or service, to likely beeffective and/or to be safe for a person ; and / or(d ) is used to confirm a Product or Licensed Product ’s biological activity and/or to optimizedosing or the scheduled administration of a Product or Licensed Product