definiens: : shall mean an assay provided as a product or service performed on a human tissue or other human biological sample containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and : PageJ CONFIDENTIAL TREA TMENT ( 1 ) diagnosis of the presence of, or absence of, a specific disease(s ), state(s ) or condition(s ) in humans ; ( ii ) predisposition to the presence of, or absence of, a specific disease(s ), state(s ) or condition(s ) in humans ; ( iii ) response or lack of response to disease therapy(ies ) in humans or preventative strategies in humans ; ( iv ) prediction of the disease course in humans . and or other changes in state(s ) or condition(s ) in humans over time ; ( v ) clinical traits in humans for which a medical professional should be consulted ; ( vi ) variation(s ) in specific trait(s ) and/or characteristics among individuals ; and/or ( vii ) predisposition to development of toxicities to disease therapies or preventative strategies in humans