Periodic Reporting for period 2 - SmartGuide (Smart Biopsy Tool for Real-Time Cancerous Cell Characterization at the Tip of the Needle)
Reporting period: 2018-01-01 to 2018-12-31
Breast biopsies are a critical step in the diagnosis of suspect breast lesions, it is a procedure where part or all of a suspicious breast tissue growth is sampled and examined for the presence of cancer.
If the histological analysis of the tissue collected in the biopsy does not match the mammography, the patient will have to undergo a new biopsy. If the tissue removed for histological analysis does not correspond to the most advanced stage of the disease, the diagnosis will be incorrect and the patient might not receive adequate treatment.
NLBB used to be the gold standard procedure for the diagnosis of non-palpable breast lesions. However, it is a surgical procedure with high costs and for most of the patients, a traumatic experience. In the past few decades, less traumatic and cost-saving non-operative image-guided techniques, such as FNA and LCNB, have been advocated as an alternative.
However, even with the most advanced available methods, the staging of the cancer disease based on the biopsy sample remains a major challenge. The cancer is often “under-staged”, meaning that the sample collected for pathological examination does not reflect the most advanced stage of the disease and therefore the follow-up patient treatment is not optimized. In addition, up to 6% of the biopsies lead to false negative results, which means that some of the cancers are missed and the correct diagnosis is only done later, once cancer has progressed further. Furthermore, up to 18% of the patients have to undergo repeat biopsies due to inconsistent findings between histopathological and imaging analyses. In practice, about 25% of these repeat biopsies eventually lead to a carcinoma diagnosis, simply because the initial biopsy was not taken from the most advanced stage of the disease.
Altogether, every one million patients undergoing core needle biopsy will generate, on average:
•200,000 repeat procedures during which approximately 50,000 patients will be upgraded to a malignancy.
•Up to 40,000 patients incorrectly diagnosed as healthy.
•5,000 hematomas and 10,000 infections related to open biopsies perform to rule out malignancies.
SmartGuide is a novel type of diagnostic modality based on dielectric spectroscopy providing real-time information regarding the tissue properties during the biopsy procedure, it does not replace the need for histological analysis, but it makes sure that the excised tissue represents the most advanced stage of the disease so the subsequent histological analysis leads to an accurate diagnosis.
The main objective of the project is to improve the accuracy of the diagnosis, reduce the under staging risk by 95%, reduce the false negative rate by 80%, reduce the number of repeat biopsies by 80% and the number of excisional open breast biopsies by 50%.
The project results will lead to improved diagnosis, reduced clinical risks associated with unnecessary biopsies, and ultimately reduce costs for health providers, while improving the standard of care and quality of life for the patients.
In addition, production flowcharts and required production instructions were established and production tools were developed.
Batches of system’s components were manufactured, part of them were manufactured for V&V purposes, and part for clinical study routine use. Part of the assemblies were carried out at sub-contractor sites, and part at Dune lab by the R&D qualified staff, according to dedicated procedures.
V&V plan for the Biopsy system and corresponding V&V tests protocols were established, ensuring all design inputs and technical specifications requirements are covered by supporting V&V tests (sterilization, safety etc). All tests were successfully completed prior to the clinical study initiation.
In the clinical field, 3 sites were chosen to participate in the study and the principal investigators at each site were chosen as well. A clinical investigation plan for a single arm multi-center study was developed along with the required study-related documents. All required approvals for the clinical study were achieved, including Israeli MOH approval.
So far over 45 cases were conducted as part of the clinical study, 115 biopsy cores were analyzed, in 100 of them, the device readings were in correspondence to the histopathological analysis, showing 87% success of accurate breast tissue real-time characterization.
In the commercialization and communication field, comprehensive market analysis was conducted and a detailed commercialization plan and communication plan were established based on it. During the project period, the activities detailed in those plans were implemented in order to ensure success in the breast cancer field and to publicize the funding received by the EU Horizon 2020 grant. Those activities included participating in conferences, establishment of project website, meetings with potential customers to create a user community and a partner ecosystem, publications on social media channels, etc.
In order to achieve CE Mark and according to “Regulation of the European Parliament and of the Council on medical devices (MDR)” draft of CE certification technical file was prepared, and the risk class of the biopsy device was classified as class IIa.
SmartGuide has the potential to change the standard of care in breast cancer diagnosis, by addressing the top three issues that increase costs for healthcare providers and decrease the quality of care for patients:
•Studies have shown that up to 18% of patients undergo repeat biopsies due to inconsistent findings between imaging and histopathological analyses. These repeat biopsies reveal carcinoma in up to 25% of cases and could have been avoided with SmartGuide.
•ADH (benign lesion) patients will undergo an open biopsy and 10-25% of these patients will be upgraded to DCIS or IDC (malignant lesions), requiring a lumpectomy. These patients have undergone unnecessary open biopsy (more expensive and traumatic than a normal biopsy) and could have potentially gone right to lumpectomy with SmartGuide.
•All DCIS patients will undergo lumpectomy, typically without sentinel lymph node biopsy (SLNB),and 20% of these patients will be upgraded to invasive cancer after analysis of the surgical sample, requiring a second surgery for SLNB. These patients have undergone unnecessary repeated surgery and could have potentially gone right to SLNB in the first procedure with SmartGuide.
The estimation of the potential savings is 276M EUR per 1M biopsies.