Analytical Concordance Between OncoMetastat® and OncoDiscover®
17
True Positives
01
False Positives
01
False Negatives
13
True Negatives
94.4 %
Sensitivity
92.9 %
Specificity
94.4 %
PPV (Positive Predictive Value)
92.9 %
NPV (Negative Predictive Value)
93.8 %
Accuracy
93.7 %
Balanced Accuracy
OncoDiscover® is a DCGI-approved CTC enumeration assay employing EpCAM immunocapture and CK/CD45/DAPI staining; it served as the internal reference method in this preliminary analytical assessment. Data are from internal studies and has not been reviewed or approved by the U.S. FDA.
N=32
CTC Captured by
OncoMetastat®
Brightfield
DAPI
CK18
Merge
CTCs Captured on OncoMetastat® Platform on the EpCAM/Tf functionalized glass bead.
Blood Parameter Testing with OncoMetastat®
Evaluation of Potential Hemolysis in OncoMetastat® (OMS)
0.9 %
OncoSpiral
0.8 %
Glass Beads
<2.0 %
OMS Device
Blood Protein Level Changes During OncoMetastat® Processing
70
mg/m
Control Serum
68.96
mg/m
Processed Serum
1.5 %
Protein Loss to Processing
Evaluation of Leucocyte (WBC) Adsorption on OncoMetastat® Beads
2+/-1
WBC Count (Bead-adherent WBCs)
OMS Processing
1+/-1
WBC Count (Bead-adherent WBCs)
OMS (with Vibration)
Evaluation of OncoMetastat® Induced Pyrogenicity
37 °C
Body Temperature
Control
37+/-0.5 °C
Body Temperature
OMS
References
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Khandare, et. al. Automated Continual Flow Device to Deplete Circulating Tumor Cells using Spiral Cartridge Mediated by Antibody and Transferrin Glass Substrate. The Journal of Liquid Biopsy 2025; 9; 100334.
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Khandare, et. al. Extracorporeal microchannel device to capture and eliminate circulating tumor cells from cancer patient’s blood. J Clin Oncol 2022; 40.
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Khandare, et. al. Device for the enumeration and continuous removal of circulating tumor cells in improving overall survival of epithelial cancer patients. J Clin Oncol 2020; 38.