“…Out of 62 studies reporting on HER2 positivity prevalence by IHC, 26 (41.9%) used the positivity definition and grading criteria consistent with ASCO/CAP 2007, 2013, or 2018 guidelines and have been classified as ASCO/CAP compliant, while the remaining 36 (58,1%) studies were classified as ASCO/CAP non-compliant ( Fig 3 and Table 1 ). Among ASCO/CAP compliant studies, five used the 30% positivity cut-off point (ASCO/CAP 2007) [ 25 , 38 , 40 , 48 , 52 ], and 19 studies the 10% cut-off point (ASCO/CAP 2013 or 2018) [ 30 , 36 , 37 , 39 , 41 , 42 , 44 , 45 , 47 , 49 , 51 , 55 , 56 , 58 , 60 , 65 , 67 , 70 – 72 ]. Nine out of 11 studies that used ISH followed ASCO/CAP compliant or slightly more stringent positivity criteria ( S6 File ).…”