Table 2.

AKRO-QC-ICG imaging Pluronic F-127 hydro-gel#30 detects the human breast cancer tissue in vivo with a high sensitivity and specificity in NSG PDX mouse models.

Measure	Group Examined	n	Estimate	95% CI 2-Sided
Sensitivity	All samples	16	0.941 (16/16)	(0.692–0.997)
Specificity	All samples	20	1.000 (19/20)	(0.790–1.000)

Note: to assess efficacy of AKRO-QC-ICG hydro-gel#30 formulation for detecting cancerous tissue in vivo, the correlation between the inked areas, i.e., fluorescence, and pathologically confirmed cancer was determined as in Figure 4D. This PDX model dataset consists of 10 NSG mice with TM000098 (n = 3), TM000091 (n = 2), TM000089 (n = 2), and TM000284 (n = 3) human patient breast adenocarcinomas isolated cell xenografts as a PDX model. Since a mouse could have more than one tumor xenograft, the total number of samples was more than the number of animals tested. Ten NSG mice contributed 12 samples (tumors). Within a tissue cut, both tumor and surrounding normal tissues were captured. For each area (spot), the presence of black ink, indicating fluorescence, was recorded. From the 12 samples, a total of 12 histology slides (cuts) were made, and, on these 12 slides, there were a total of 36 areas (spots), 16 marked as having tumor and 20 marked as having no tumor. Analyses of the data to estimate sensitivity and specificity were carried out on a per-spot basis using pathological correlation of cancer with black ink, i.e., fluorescence.