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BACKGROUNDScreening of asymptomatic women for early detection of Breast Cancer (BrC) is associated with improved survival. Presently, mammography is the standard of care (SoC) for BrC screening but has lower accuracy for invasive cancers as well as in women with higher breast tissue density.METHODSIn this manuscript, we describe an accurate blood-based breast cancer detection test based on functional enrichment of breast adenocarcinoma associated circulating tumor cells (BrAD-CTCs) and their identification via multiplexed fluorescence immunocytochemistry (ICC) profiling for GCDFP15, GATA3, EpCAM, PanCK and CD45 status.RESULTSThe test accurately detects BrAD-CTCs in breast cancers irrespective of age, ethnicity, disease stage, grade and hormone receptor status. Analytical validation established the high accuracy and reliability of the test under intended use conditions. A case-control study with samples from 9,632 healthy women and 548 known BrC cases established 100% specificity and 92.07% overall sensitivity; stage-wise sensitivities were 70.00% for Stage 0, 89.36% for Stage I, 95.74% for Stage II and 100% for Stage III and Stage IV cancers. In a prospective clinical study with 141 suspected cases of breast cancer who underwent a biopsy after blood collection, the test showed 93.1% specificity and 94.64% overall sensitivity in differentiating breast cancer cases (n = 112) from those with benign breast conditions (n = 29); stage-wise sensitivities were 87.50% for Stage 0, 95.83% for Stage I and Stage II, 95.00% for Stage III and 100% for Stage IV cancers.CONCLUSIONThe findings reported in this manuscript support the clinical potential of this test for blood based BrC detection. |
