Details
Project Title: RApid Oncology Diagnosis
Acronym: DORA
Abstracts: The project aims to develop a set of new tools for molecular diagnostics of oncological diseases characterized by high levels of diagnostic sensitivity, standardization, speed and ease of use intended for hospital laboratories.
Name: Davide Barberio
Organization: Bioclarma
Email: davide.barberio@bioclarma.com
Phone: 011 670 64 46 | 348 407 83 85
Lead Partner: Bioclarma Srl
Other partners: Aethia Srl
Type: Industrial research and/or experimental development project
Line: A
Topic: In Vitro Diagnostics
Duration: 24 months
Total project costs: 320,000 €
Total contributions requested: 160,000
Status: ongoing project
THE DESIGN IDEA
In many oncological diseases, a rapid diagnosis that can indentify specific molecular markers is an indispensable tool for diagnosis, prognosis, and therapeutic treatment management. Given the character of urgency lined by these diseases at the time of their clinical onset, there is a need to conduct this diagnosis as quickly as possible.
High-sensitivity techniques are critical to discriminate patients who, although asymptomatic, still have a significant amount of residual disease (MMR). Bioclarma currently produces a Product line called SensiQuant that enables monitoring of minimal residual disease in patients with Chronic Myeloid Leukemia.
Leveraging on the one hand the partnership’s strong technical and scientific expertise in molecular diagnostic methods and the development of innovative information technology solutions, and on the other hand through collaboration with research organizations, the consortium aims to bring to the market an integrated diagnostic system that can be used by all laboratories in a standardized manner, without the need for complex workflow and data management, a tool for rapid molecular diagnosis of various forms of neoplastic disease.
DEVELOPMENT GOALS
The project aims to:
- To develop a new product line based on a direct, fast and sensitive method for rapid molecular diagnosis of certain forms of neoplastic disease;
- Implement software that can interface with analysis tools and hospital management systems that manages the diagnostic pathway, provides interpretation of results, and is an effective tool for standardization of the data obtained and quality control procedures. This IT platform will be provided to accompany both the SensiQuant line of products for MMR monitoring and the new line of products for rapid molecular oncology diagnosis.
SCIENTIFIC VALUE AND POTENTIAL ECONOMIC IMPACT OF THE PROJECT
The integrated proposal of IVD software and reagents represents an innovation in the landscape of oncology diagnostics and will allow the substantial reduction of analysis time compared to the methods currently available on the market, simplification of the analytical procedure while adapting the new method to the platforms already in use in laboratories.
Bioclarma has developed a prototype-state diagnostic system that has been shown to highlight the presence or absence of molecular markers with a rapid and simple analysis protocol. The possibility of speeding up this analytical step, in conjunction with a computer support for interpretation of results to be developed by Aethia has a threefold advantage:
- Substantial reduction in analysis time compared with currently commercially available methods
- Simplification of the analytical procedure that would allow the test to be performed even by nonspecialists
- Adaptation of this method on the instrumental platforms already commonly found in analytical laboratories
The integrated proposal of IVD software and reagents represents an innovation in the oncology diagnostic landscape and possesses both technical and economic competitive advantages, with both economic and management-organizational benefits for potential customers.
