• What is the problem/issue being addressed?
Tumour heterogeneity emerges as a major cause of therapy failure and resistance to various oncology treatments. Accurate identification of the biomolecular profile of manageable targets requires multiple samples that are collected throughout the target, high-quality tissue samples, and preservation of labile biomarkers. False positive or negative results from the evaluation of biomarkers, or incomplete biomolecular profile of the disease, can directly affect patient diagnosis, treatment and outcomes. For most types of cancer, where correct diagnosis is critical, biopsy is the main source for biomarkers. Most of current devices do not collect multiple samples from multiple sites as needed for accurate and reliable diagnosis and do not provide rapid preservation of tissue samples.
• Why is it important for society?
We develop the Multi-Core Biopsy Device (MCBD) to eliminate current limitations in biopsy collection and processing. The MCBD provides substantial cost saving through the following innovations and improvements:
- Multi-core biopsy acquisition from different sites in a volume of interest (VOI) through single needle insertion will cut down the duration of the biopsy procedure, will save costs on physician fee, nurse and other clinical staff fees, and scanner use, and will provide more comprehensive assessment of the target to better account for tumour heterogeneity.
- Multimodal preservation compared with current formalin preservation will cut down costs on the use of kits that are needed to analyse the formalin-fixed tissue samples.
- About 50-60% of breast biopsies are done with costly vacuum-assisted biopsy (VAB) devices with price tags of €300-400, compared with price tag of €50-60 per use with the motorized MCBD.
- The sectionable cartridge will eliminate manual handling of multiple biopsy samples and will reduce substantially the costs of downstream processing in the pathology lab.
The new MCBD device will contribute to the emerging concept of precision/ personalized medicine, that by targeting the best treatment to each patient will improve outcome for patients with treatable targets and will eliminate unnecessary, disabling therapies to non-suitable patients. This will have an enormous impact on society by improving quality of life and survival of patients, benefiting not only the patients but also to their families and caregivers.
• What are the overall objectives?
1 - Optimize the design of motorized MCBD for acquisition and rapid preservation of multiple biopsy samples from a volume of interest (VOI).
2 - Conduct animal tests to assess the advantages of motorized MCBD in comparison with standard biopsy device.
3 - Conduct clinical study to demonstrate advantages of motorized MCBD.
4 - Get FDA clearance and then CE mark for the motorized MCBD device.
5 - Achieve additional funding to enable commercialization of the developed technology and establish strategic partnership alliances with corporations from various fields – medical devices, pharmaceutical and In-Vitro Diagnostic companies.
