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 could be used to treat and / orprevent such disease or condition;(b)defines the prognosis or monitors the progress of a disease or condition in a person for which aProduct could be used to treat and/or prevent such disease or condition;(c)is used to select a therapeutic or prophylactic regimen, wherein at least [ * * * ] potential therapeutic orprophylactic regimen involves a Product, and where the selected regimen is determined, based onthe use of such product or service, to likely be effective and/or to be safe for a person ; and / or(d)is used to confirm a Product ’s biological activity and/or to optimize dosing or the scheduledadministration of a Product