The experimental design seems very small scale though. 17 cancer positive samples (of which only 1 was HER2 positive), 4 control. Since the strips are focused on HER2 detection I read this as "in 1 out of 1 samples, our test detected HER2 overexpression" but maybe I misread it.
[0] https://pubs.aip.org/avs/jvb/article/42/2/023202/3262988/Hig...