definiens: : shall mean a Mlilti - Analyte Assay(s ) provided as a product or a service 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 ancl : ( i ) diagnosis of the presence of, or absence of, a specific disease(s ), staters ) or condition(s ) in humans ; Page 7 CONFIDENTIAL TREA TMEI T ( 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