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Exosomes (30-150 nm) are the smallest type of extracellular microvesicles (EMV), produced through inward budding multivesicular bodies (MVB), resulting in intra-luminal vesicles (ILV). ILVs are released into the extracellular media by exocytosis. Exosome-associated proteins are used to isolated microvesicles from biological fluids such as blood, urine or cerebral fluid and to identify the source of their origin. Example of such proteins are tetraspanins (CD9, CD63, CD81), immune regulation molecules (HLA-G, MHCI/II), membrane transport and fusion proteins (Rab5). Secretion of exosomes occurs by almost any “normal cell” such as thrombocytes, cells of the immune system, epithelial cells, or disease tissue, like tumor cells and virus-infected cells.

Oncosome.HER2 is a liquid biopsy diagnostic for the detection of HER2 in blood to identify patients eligible for HER2 targeted therapy. Oncosome.HER2 would address an high unmet medical need.

The acute SARS-CoV-2 infection is diagnosed routinely through PCR-based detection of viral RNA from nasopharyngeal swabs. Additionally, direct antigen detection of viral proteins is now available. The specific detection by PCR has a high sensitivity and specificity but delivers a false-negative rate of up to 38 % at the time of symptoms (Kucirka et al. 2020). The sensitivity and specificity of antigen detection tests are lower than PCR-based detection caused by methodology (CDC, Guidelines, August 1, 2020).

Interest in exosome research has increased dramatically in recent years due to their unique functions as intercellular messengers, abilities to alter recipient cell bioactivities, as well as in disease diagnostics. Despite significant efforts made in this relatively new field of research, progress has been held back by challenges such as inefficient separation methods, difficulties in characterization, and lack of specific biomarkers. Current applied methods for exosome purification are ultracentrifugation, precipitation with PEG, immunocapture with antibodies against CD9, CD63, CD81, TSG, Rab5 and others, microfluidic isolation or filtration. All these methods do not isolate all exosomes mainly subpopulations or even destroy the microvesicles during purification.

Personalized medicine aims to identify patients who require treatment and subsequently select the right therapy based on individual factors and tumor characteristics, i.e. personalized medicine targets to identify the right patients for the right therapy. Prognostic biomarkers provide information on the risk of disease recurrence whereby predictive ones will inform the physician of the potential clinical response of the patient to a given cancer therapy. “In personalized medicine biomarkers are used to predict prognosis (prognostic biomarkers) and treatment success (predictive biomarkers)”.