definiens: means the use of the SELEX ™ Process or Aptamers o r PhotoAptamers identified through theuse of the SELEX ™ Process in the assay, testing or determination, outside of a living organism, of a s ubstance in a testmaterial . In Vitro Diagnostics shall include, among other things, the use of the SELEX ™ Process or Aptamers orPhotoAptamers identified through the use of the SEL EX ™ Process in the assay, testing or determination : ( a ) outside of aliving organism, ( i ) of a human substance in a test material, often to identify or follow the progress ion of a disease or disorder, or to select a patient for treatment ; ( ii ) of a pla nt substance, animal substance or other substance i n a test material, often toidentify or follow the progression of a disease, pr ocess, or disorder in a human or non - human organism ; and ( iii ) ofenvironmental substances ( as in water quality testi ng ) ; and ( b ) of a substance on a test material such as cells ( as in FACSanalysis or other measurements of pathogens within biological samples )