Exosomics Siena SpA
The Liquid Biopsy
New paradigm for non-invasive Cancer Diagnostics
We develop exosome based solutions for non-invasive unmet medical and pharmaceutical diagnostic needs
Exosomics Siena SpA is an innovative company located in Siena – Italy, developing exosome (and microvesicles) based diagnostics with a proprietary approach. Exosomics’ long lasting experience and unique expertise of its scientists, together with a significant IP portfolio, makes of Exosomics an acknowledged pioneer and an industrial leader in exosome science and in the diagnostic space.
Exosome-based diagnostics represents a cutting edge innovative frontier for cancer research and clinical management.
Science and Technology
Cells, cancer cells in particular, continually secrete a large number of small vesicles, macromolecular complexes and small molecules into the extracellular space. Of the secreted vesicles, nano- and micro- vesicles (exosomes and others) are currently being intensely investigated for their physiological role and unprecedented potential in biomedicine. Exosomes (and other microvesicles) contain active biomolecules, namely nucleic acid, proteins and lipids, mediating their traffic and inter cellular exchange between diverse compartments within the body, as well as characteristic discharge products. Exosome release is a well regulated process also reflecting early changes in cell metabolism or in cell-to-cell interactions in a tissue. This means that exosomes are early sentinels of cell/tissue alterations. Exosomes are secreted by all types of living cells and also found in abundance in body ﬂuids including blood, saliva, urine and breast milk. Due to their sorted and protected cargo they are considered as a privileged source of different types of biomarkers and an appealing biological material for biomarker discovery. Using exosomes as sources of concentrated multiple cancer biomarkers, Exosomics has created a range of novel diagnostic solutions. Exosomics platform is based on patented methods to immuno-capture exosomes and microvesicles, particularly specific subpopulations of cancer released vesicles, and to characterize their cargo of proteins or nucleic acids with immunodiagnostic (ID) and molecular diagnostic (MD) techniques. This is a simple, inexpensive platform based on ELISA-like assays. Exosomics’ platform uses proprietary assays with patented technology together with proprietary biomarker panels and antibodies. Besides the technological innovation of the Exosomics’ platform, Exosomics introduces a new, simple, elegant concept providing new features to consolidated markers. Today, soluble biomarkers are identified in the bloodstream mostly using ELISA or ELISA-like techniques. Nevertheless, soluble cancer biomarkers are just simply tissue biomarkers, and likely to be elevated in normal or non-cancerous conditions. Soluble PSA is a typical example. PSA can also be associated with exosomes, either released by normal or tumour cells. In the latter case the exosomes will co-express a tumour specific biomarker, used by the Exosomics method to selectively capture tumour originated exosomes. In this manner Exosomics method does not take into account either soluble PSA or PSA associated with exosomes which are not co-expressing another tumour biomarker, but targets only the set represented by an exosome co-expressing PSA and a second specific tumour marker.
Exosomics’ assays target more than two protein biomarkers per tumour (usually 3 or 4) in order to increase the robustness of the assay. Exosomics technology adopts exosome and microvesicle associated biomarker panels, developed in-house, falling into the following categories:
– Warburgian (related to tumor specific energetic metabolism features) exosome associated protein biomarkers. These are used to capture tumor derived exosomes (and are promising for the development of a solid cancer screening test, conveying high sensitivity and specificity).
– Reliable and clinically adopted exosome associated biomarkers, such as PSA, detected in combination with Warburgian biomarkers in an “exosome set”.
This approach significantly improves sensitivity and specificity of currently used biomarkers whilst introducing the ‘liquid biopsy’ concept in cancer diagnostics. The reason why a soluble tumor biomarker gains higher sensitivity and specificity in an “exosome set” is illustrated in the figure below.
Exosomics’ proprietary platform (EXOTEST™) is an immunodiagnostic (ID) technology already established and currently commercialized in the life sciences market for research use only applications. The platform is flexible and versatile allowing the implementation of novel capturing and detecting agents as well as upstream and downstream steps for extended features.
The EXOTEST™ platform is also suitable to analyse exosome shuttled RNA and DNA sequences. Exosome shuttled nucleic acids, mostly mutations and transcripts of cancer related genes, can be used for non-invasive patients’ profiling and monitoring of cancer evolution, therefore for patients’ stratification and monitoring.
Exosomics state of art assays are readily compatible with off-the-shelf equipment already adopted in clinical settings while alliances with leading technological partners is paving the way for the adoption of novel proprietary technologies and high tech solutions.
Collaborative and Contract Research Activities
We pursue collaborative projects with other entities (companies, academies, research centers) under different schemes and the creation of consortia aiming at rising complementary funding to co-develop activities and products of common interest.
We provide consultancy and technological services in exosomes manipulation and analysis (such as but not limited to sample preparation, sample analysis and characterization, specific training, etc.).
To address specific client’s needs, we conduct ad hoc contract studies in unexplored areas to test feasibility of specific exosomes based applications in diagnostics, companion diagnostics or therapy.
• Exosome based test for prostate cancer, with specificity and sensitivity never reached before;
• Exosome based test for colorectal cancer, with specificity and sensitivity never reached before;
• Exosome based screening test for solid tumors, with very high specificity and sensitivity;
• Companion diagnostic kits for several categories of drugs (in collaboration with pharma industries);
• Non-invasive testing of mutation (BRAF, KRAS and others).