- 1.“The phenotype or property. . . should be associated with pathogenic members of a
- genus or pathogenic strains of a species”
- 2.“Specific inactivation of the gene(s) associated with the suspected virulence trait
- should lead to a measurable loss in pathogenicity or
- virulence”
3.“Reversion or allelic replacement of the mutated gene should lead to restoration of pathogenicity”
4.Gene should be expressed during disease process
5.Immune activity against gene product should protect