Table IIb.
FDA808k-1 multiple-organ cancer tissue array, including the pathology diagnosis and results of Tn expression studies by IHC
| FDA808k-2 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| No | Age | Sex | Organ/Anatomic Site | Pathology diagnosis | TNM a | Grade | Stage | Type b | Tn expression c |
| A1 | 48 | F | Uterus | Adjacent normal endometrium tissue | - | - | - | NAT | - |
| A2 | 18 | F | Uterus | Endometrium tissue | - | - | - | Normal | - |
| A3 | 41 | F | Cervix | Adjacent normal endometrium tissue | - | - | - | NAT | - |
| A4 | 36 | F | Cervix | Cancer adjacent cervical canals tissue | - | - | - | AT | - |
| A5 | 72 | F | Cervix | Adjacent normal cervix tissue | - | - | - | NAT | - |
| A6 | 65 | F | Cervix | Adjacent normal cervical canals tissue with squamous metaplasia | - | - | - | NAT | - |
| A7 | 40 | M | Skeletal muscle | Skeletal muscle tissue | - | - | - | Normal | - |
| A8 | 49 | F | Skeletal muscle | Adjacent normal skeletal muscle tissue | - | - | - | NAT | - |
| A9 | 50 | M | Skeletal muscle | Skeletal muscle tissue | - | - | - | Normal | - |
| B1 | 34 | M | Skin | Skin tissue of chest part | - | - | - | Normal | - |
| B2 | 21 | M | Skin | Skin tissue | - | - | - | Normal | - |
| B3 | 35 | M | Skin | Skin tissue of abdomen part | - | - | - | Normal | - |
| B4 | 23 | M | Nerve | Peripheral nerve tissue | - | - | - | Normal | - |
| B5 | 25 | M | Nerve | Peripheral nerve tissue | - | - | - | Normal | - |
| B6 | 50 | M | Nerve | Peripheral nerve tissue | - | - | - | Normal | - |
| B7 | 33 | M | Lung | Diaphragm tissue and mesothelial tissue | - | - | - | Normal | - |
| B8 | 19 | M | Cardiac pericardium | Pericardium tissue and mesothelium tissue | - | - | - | Normal | - |
| B9 | 43 | M | Cardiac pericardium | Diaphragm tissue and mesothelial tissue | - | - | - | Normal | - |
| C1 | 17 | M | Cerebrum | Glioblastoma | - | 4 | - | Malig | - |
| C2 | 65 | F | Cerebrum | Atypical meningioma | - | - | - | Malig | - |
| C3 | 40 | F | Cerebrum | Glioblastoma | - | 4 | - | Malig | - |
| C4 | 39 | F | Cerebrum | Oligodendroglioma | - | 2 | - | Malig | - |
| C5 | 62 | F | Ovary | Endometrioid carcinoma | T2N0M0 | 3 | II | Malig | Positive |
| C6 | 29 | F | Ovary | Mucinous adenocarcinoma | T3N0M0 | 3 | III | Malig | Positive |
| C7 | 16 | F | Pancreas | Islet cell tumor | - | - | - | Malig | - |
| C8 | 64 | M | Pancreas | Adenocarcinoma | T3N0M0 | 3 | IIA | Malig | Positive |
| C9 | 32 | M | Testis | Seminoma | T1N0M0 | - | IA | Malig | - |
| D1 | 30 | M | Testis | Embryonal carcinoma | T2N0M0 | - | IB | Malig | - |
| D2 | 33 | F | Thyroid gland | Medullary carcinoma | T3N0M0 | - | II | Malig | - |
| D3 | 46 | F | Thyroid gland | Papillary carcinoma | T4N0M0 | - | IVA | Malig | - |
| D4 | 67 | F | Breast | Intraductal carcinoma | TisN0M0 | - | 0 | Malig | - |
| D5 | 58 | F | Breast | Invasive ductal carcinoma | T3N1M0 | 2 | IIIA | Malig | Positive |
| D6 | 42 | F | Breast | Invasive ductal carcinoma | T2N1M0 | 3 | IIB | Malig | Positive |
| D7 | 21 | M | Spleen | Diffuse B-cell lymphoma | - | - | - | Malig | - |
| D8 | 61 | M | Lung | Small cell undifferentiated carcinoma | T2N0M0 | - | IB | Malig | - |
| D9 | 64 | M | Lung | Squamous cell carcinoma | T2N0M0 | 3 | IB | Malig | - |
| E1 | 42 | M | Lung | Adenocarcinoma | T2N0M0 | 3 | IB | Malig | - |
| E2 | 58 | M | Esophagus | Squamous cell carcinoma | T3N1M0 | 2 | IIIA | Malig | Positive |
| E3 | 63 | M | Esophagus | Adenocarcinoma | T3N0M0 | 3 | IIA | Malig | Positive |
| E4 | 73 | F | Stomach | Adenocarcinoma | T2N1M0 | 3 | IIA | Malig | Positive |
| E5 | 64 | F | Small intestine | Adenocarcinoma | T4N0M0 | 3 | IIB | Malig | Positive |
| E6 | 71 | F | Small intestine | Malignant mesenchymoma | T2N0M0 | - | I | Malig | - |
| E7 | 72 | F | Colon | Adenocarcinoma | T4N0M0 | 2 | IVA | Malig | Positive |
| E8 | 54 | M | Colon | Mesenchymoma | T2N0M0 | - | I | Malig | - |
| E9 | 36 | M | Rectum | Adenocarcinoma | T2N0M0 | 2 | I | Malig | - |
| F1 | 63 | F | Rectum | Malignant mesenchymoma | T2N0M0 | - | I | Malig | - |
| F2 | 55 | F | Liver | Hepatocellular carcinoma | T3N0M0 | 2 | IIA | Malig | - |
| F3 | 17 | F | Liver | Hepatoblastoma | - | - | - | Malig | - |
| F4 | 60 | M | Kidney | Clear cell carcinoma | T2N0M0 | 1 | II | Malig | - |
| F5 | 80 | M | Prostate | Adenocarcinoma (Gleason grade:4) | T3N0M0 | 3 | III | Malig | Positive |
| F6 | 77 | M | Prostate | Adenocarcinoma (Gleason grade:5) | T2N0M0 | 3 | IIB | Malig | Positive |
| F7 | 56 | F | Uterus | Lowly malignant leiomyosarcoma | T2N0M0 | - | II | Malig | - |
| F8 | 50 | F | Uterus | Endometrioid adenocarcinoma | T1bN0M0 | 1 | IB | Malig | Positive |
| F9 | 57 | F | Uterus | Clear cell carcinoma | T1bN0M0 | - | IB | Malig | Positive |
| G1 | 36 | F | Cervix | Squamous cell carcinoma | T1bN0M0 | 3 | IB | Malig | Positive |
| G2 | 49 | F | Cervix | Squamous cell carcinoma | T2N0M0 | 3 | II | Malig | Positive |
| G3 | 20 | F | Skeletal muscle | Embryonal rhabdomyosarc-oma of left leg | T1aN0M0 | - | IA | Malig | - |
| G4 | 70 | F | Rectum | Malignant melanoma | - | - | - | Malig | - |
| G5 | 85 | F | Skin | Basal cell carcinoma of left face | T2N0M0 | - | II | Malig | - |
| G6 | 64 | M | Skin | Squamous cell carcinoma of chest wall | T3N0M0 | 2 | III | Malig | - |
| G7 | 21 | M | Nerve | Neurofibroma of back | - | - | - | Malig | - |
| G8 | 1 | F | Retroperitoneum | Neuroblastoma | - | - | - | Malig | - |
| G9 | 60 | M | Peritoneum | Malignant mesothelioma | T2N0M0 | - | II | Malig | Positive |
| H1 | 55 | M | Lymph node | Diffuse B cell lymphoma of armpit | - | - | - | Malig | - |
| H2 | 50 | F | Lymph node | Diffuse B cell lymphoma of right thigh | - | - | - | Malig | - |
| H3 | 27 | M | Lymph node | Mixed cell type Hodgkin‘s lymphoma of left groin | - | - | - | Malig | - |
| H4 | 36 | M | Lymph node | Anaplastic large cell lymphoma of left groin | - | - | - | Malig | - |
| H5 | 58 | F | Bladder | High grade urothelial carcinoma | T2N0M0 | - | II | Malig | Positive |
| H6 | 62 | M | Bladder | Leiomyosarcoma | T2N0M0 | - | II | Malig | - |
| H7 | 37 | F | Cartilage | Osteosarcoma of left femur lower section | T2N0M0 | - | IIB | Malig | - |
| H8 | 48 | F | Retroperitoneum | Highly malignant pleomorphic rhabdomysarcoma | T2N0M0 | - | IIB | Malig | - |
| H9 | 60 | F | Smooth muscle | Moderate malignant leiomyosarcoma of left buttock | T2N0M0 | - | IIB | Malig | - |
| H10 | 42 | M | Adrenal gland | Pheochromocytoma (tissue marker) | - | - | - | Malig | - |
a TNM grading, T—Primary tumor, Tx—Primary tumor cannot be assessed, T0—No evidence of primary tumor, Tis—Carcinoma in situ; intraepithelial or invasion of lamina propria, T1—Tumor invades submucosa, T2—Tumor invades muscularis propria, T3—Tumor invades through muscularis propria into subserosa or into non-peritonealized pericolic or perirectal tissues, T4—Tumor directly invades other organs or structures and/or perforate visceral peritoneum, N—Regional lymph nodes, Nx—Regional lymph nodes cannot be assessed, N0—No regional lymph node metastasis, N1—Metastasis in 1 to 3 regional lymph nodes, N2—Metastasis in 4 or more regional lymph nodes, M—Distant metastasis, Mx—Distant metastasis cannot be assessed, M0—No distant metastasis, M1—Distant metastasis, N—Regional lymph nodes, Nx—Regional lymph nodes cannot be assessed, N0—No regional lymph node metastasis, N1—Metastasis in 1 to 3 regional lymph nodes, N2—Metastasis in 4 or more regional lymph nodes, M—Distant metastasis, Mx—Distant metastasis cannot be assessed, M0—No distant metastasis, M1—Distant metastasis
b Type, Normal—Normal tissue, NAT—Normal adjacent tissue, AT—Adjacent tissue, Malig—Malignant tissue
c Tn expression, Indicates positive or negative staining in IHC
*Intracellular staining